Monogram Biosciences Inc (MGRM)

[steviee]

7:04AM Monogram Biosciences obtains coverage for Trofile Assay from California ADAP program (MGRM) 1.36 : Co announces that the California ADAP program under the California Office of AIDS has established coverage and reimbursement for Monogram's Trofile Assay. This coverage will be administered by the "Public Health Service Bureau", the California ADAP Program's Pharmacy Benefit Manager. The California Office of AIDS has the lead responsibility for coordinating state programs, services and activities relating to HIV/AIDS for the State of California. The AIDS Drug Assistance Program, or "ADAP", is a state and federally funded program, administered separately in each state to provide healthcare coverage for HIV/AIDS patients.

[steviee]

Pfizer Receives E.U. Approval of Maraviroc; Monogram Initiates European Operations
Monday October 1, 7:00 am ET
Monogram establishes European organization for commercialization of Trofile and partners with Lab21, Ltd. in the U.K.

SOUTH SAN FRANCISCO, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced the establishment of its European organization to facilitate access to Trofile, its proprietary tropism test, following the announcement that Pfizer Inc. (NYSE: PFE - News) has received European Commission approval of the novel HIV therapy, Celsentri® (maraviroc) tablets (known as Selzentry(TM) in the U.S.). Trofile was the assay used for patient selection for maraviroc's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use globally.

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Maraviroc has been approved in the European Union for combination antiretroviral therapy for treatment-experienced adults who are infected with only CCR5-tropic HIV-1 detectable. Trofile is the only clinically validated diagnostic that can be used to determine viral tropism. Through the global collaboration, Pfizer will take the lead in commercializing Trofile outside of the U.S. Monogram will provide support for Pfizer's sales, marketing and educational activities.

Monogram also has taken several important steps towards establishing its European operations including the appointment of Corinne Danan as European Director. Ms. Danan will lead Monogram's efforts to introduce the Trofile assay in Europe and will work closely with Pfizer's European commercial team. Corinne Danan comes to Monogram with over 15 years at Eli Lilly in Europe and the United States in regional and global roles, serving as country manager in Israel and Poland as well as in a number of other marketing positions. Ms. Danan will be based in Paris.

Monogram has been working with Pfizer to develop the appropriate logistical arrangements for making Trofile available in those countries targeted for commercial introduction of maraviroc. All samples will be processed by Monogram in its laboratory in South San Francisco and Monogram is establishing, with funding from Pfizer, the laboratory and courier partnerships that are necessary to ensure that samples can be appropriately managed and delivered to South San Francisco for processing. Monogram announced that the first such partnership has been established with Lab21 Ltd., of Cambridge, U.K. Lab21 has considerable experience in HIV testing, as well as strong operations and logistics capabilities, and will provide access to Trofile in the U.K. and Ireland. Contracts are being finalized with other labs and logistics groups for the provision of such services in other European and international markets, coinciding with Pfizer's local launches of maraviroc and Trofile.

About Trofile

Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus infects the cell and it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. Monogram's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. Monogram's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the company and its technology can be found on its web site at www.MonogramBio.com.

About Lab21 Ltd.

Lab21 is a leading provider of cutting edge diagnostics, supporting drug discovery, healthcare and environmental monitoring. Its customers include healthcare providers, pharmaceutical and biotechnology companies. In addition, the Company supports organizations that need to monitor their impact on the environment. Lab21 has a rapidly growing portfolio of diagnostics to support early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry. A key function is the support of clinicians and healthcare providers as they treat and monitor patients. The company's products include diagnostic tests for cancer, liver disease, respiratory illnesses and infectious diseases such as syphilis through its subsidiary Newmarket Laboratories. Its pharmaceutical support services include lead identification and optimization of targets, drug resistance profiling, mode of action studies, and drug combination studies as well as clinical trial support. More information about the company and its technology can be found on its web site at www.lab-21.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; the amount of reimbursement that will be provided by third party payers; risks related to the implementation of the collaboration with Pfizer; whether we will be able to effectively build an appropriate organization and establish appropriate partnerships in Europe and other international markets; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a trademark and Celsentri is a registered trademark of Pfizer Inc.

contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: [phone] Tel: [phone]
[e-mail] [e-mail]


Source: Monogram Biosciences, Inc.

[steviee]

Monogram Announces First Medicare Payment for Trofile(TM)
Monday September 24, 7:00 am ET
Medicare to Pay for Trofile at Monogram's List Price

SOUTH SAN FRANCISCO, Calif., Sept. 24 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced that the first Medicare payment for its Trofile Assay has been processed, at an amount equal to Monogram's list price, by the National Heritage Insurance Company (NHIC), the contractor that administers Medicare programs in California.

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NHIC had previously established coding guidance for Trofile. For patients throughout the U.S., Medicare claims for Trofile are submitted to NHIC, which is the local Medicare part B Contractor in California, where Trofile tests are performed. NHIC's coding guidance for healthcare providers references the need for tropism testing as indicated in the FDA labeling for maraviroc, and acknowledges that Monogram's Trofile Assay was the test for tropism on which the FDA clinical trials of Selzentry (maraviroc) were based.

Monogram's Trofile Assay is the only clinically validated assay for assessing tropism of patients, is the only assay that has been used in phase II and phase III clinical trials of CCR5 antagonists, and has been used in all such clinical trials to date.

"Providing this reimbursement for Trofile is an important acknowledgement by Medicare of the value of Trofile as a tool for guiding the use of Selzentry," said William D. Young, Monogram CEO. "We are making good progress in our discussions with other public and private payers with regard to reimbursement for Trofile and, to date, we have submitted claims to 15 separate payers. We are encouraged by the initial adoption of Trofile by physicians."

About Trofile

Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus infects the cell and it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; the level of reimbursement that third party payers will authorize for Trofile; risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a
trademark of Pfizer Inc.

[wave]

Press Release Source: Monogram Biosciences, Inc.

Studies Highlight Superior Performance of Trofile(TM) Assay
Wednesday September 19, 7:00 am ET
Data based on the Trofile assay presented at 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

SOUTH SAN FRANCISCO, Calif., Sept. 19 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced multiple presentations demonstrating the strength of its Trofile(TM) Assay at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Among the presentations is one that details the superior ability of Monogram's Trofile assay to identify HIV patients that are most likely to respond to co- receptor inhibitors, a new class of drugs, compared to less sophisticated genotypic approaches. Another presentation reports on technical advances will allow improvements to be made to the assay resulting in a tenfold increase in Trofile's ability to identify patients with virus populations that harbor rare variants that are unlikely to be inhibited by specific drugs in this new class, and consequently are prone to treatment failure.
Trofile is a cell-based infectivity assay that directly and accurately determines whether HIV is able to gain entry into cells via the CCR5 or CXCR4 co-receptor, or both CCR5 and CXCR4. Last month, Pfizer Inc. (NYSE: PFE - News) received FDA approval for Selzentry(TM) (maraviroc), a CCR5 antagonist and the first orally available HIV treatment in this new class of medications. In a first for an HIV drug approval, the FDA approved label states that tropism testing should be used to guide the use of Selzentry, i.e. identify patients most likely to respond to treatment.

"As the only clinically proven assay for assessing tropism, our Trofile Assay has played a critical role in guiding the selection of appropriate patients for Selzentry in Pfizer's clinical trials and expanded access program, and that role is expanding now that drug is approved," said Monogram CEO Bill Young. "The studies presented this week enhance that position by providing further evidence of the superiority of our current Trofile Assay over potential genotypic approaches. Our presentations also detail technological advances that will improve the ability of the assay by tenfold to detect whether individuals are infected with CXCR4-tropic viruses, and therefore unlikely to respond to treatment with CCR5-inhibitors. In a world where patients and physicians are increasingly concerned about delivering the right drug to the right patient at the right time, we are pleased that Monogram continues to set the highest scientific standards in patient selection."

Trofile More Accurate than V3 Sequencing

In a study described in Abstract #H-1028, Monogram scientists compared the abilities of nucleic acid sequencing to Monogram's Trofile co-receptor tropism assay in accurately determining the tropism profile of HIV in treatment- experienced patients. Conventional nucleic acid sequencing approaches examine the genetic sequence of a relatively small region (V3) of the HIV envelope gene and use various algorithms to derive predictions of coreceptor tropism. Trofile's phenotypic approach provides a direct determination of co-receptor tropism by assessing the ability of viruses containing the entire envelope protein of a patient's virus to infect cells expressing either the CXCR4 or CCR5 co-receptor. The researchers found that determining the V3 sequences of envelope genes derived from patient viruses is technically hampered by the sequence diversity and heterogeneous length of the V3 region. The study also demonstrated that when V3 sequences can be unambiguously determined, state of the art interpretation algorithms significantly under-report the presence of viruses that use CXCR4 and are therefore highly unlikely to respond to Selzentry. Results of the study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.

Advancements in Trofile Assay Increase Sensitivity

A second study presented described in Abstract #H-1026 demonstrated that technical enhancements made to the Trofile assay allow it to identify patients that are infected with viruses that contain minor subpopulations of CXCR4- using HIV. These advances should make the Trofile assay an even more powerful tool for the selection of patients that can be successfully treated with CCR5 inhibitors. The detection of minor variants that use CXCR4 was enhanced tenfold without sacrificing the ability to reliably detect CCR5 variants. Results from this study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.

Tropism and Disease Progression

In a third study described in Abstract #H-1027, Monogram scientists evaluated the correlation between disease progression and HIV co-receptor tropism in untreated patients with chronic HIV infection. The study revealed that among these patients, individuals with viruses that can use the CXCR4 coreceptor have a faster rate of HIV disease progression compared to individuals with viruses that use only the CCR5 coreceptor. Results of this study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.

About Trofile

Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co-receptor on the cell surface. Once the virus infects the cell and it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus. The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a trademark of Pfizer Inc.


contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: [phone] Tel: [phone]
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com



Source: Monogram Biosciences, Inc.

[wave]

Press Release Source: Monogram Biosciences, Inc.

Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
Tuesday September 18, 12:10 pm ET
Pfizer reports long-term safety and efficacy data for HIV drug Selzentry(TM) (Maraviroc)


SOUTH SAN FRANCISCO, Calif., Sept. 18 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) announced today that its collaborator Pfizer, Inc. (NYSE: PFE - News) has separately announced data that reinforces long-term safety and efficacy of Pfizer's oral CCR5-antagonist, Selzentry (Maraviroc), which was recently approved by the FDA and is now available throughout the U.S. Monogram's co-receptor tropism assay, Trofile(TM), was used for patient selection for Selzentry's clinical development program, and is currently being marketed by Monogram's 50-strong sales and marketing organization. Recently, Monogram announced that the contractor that administers Medicare programs in California has established coding procedures for the company's Trofile Assay, indicating Medicare coverage of Trofile throughout the U.S.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Chicago, Pfizer presented data from a planned 48-week analysis of its clinical studies of Selzentry in treatment-experienced patients. This analysis confirms the previous 24-week data on which the FDA approval of Selzentry was based. The 48-week analysis showed:


-- that nearly three times as many patients receiving Selzentry in
addition to an optimized background regimen achieved undetectable
levels of virus compared with those receiving an optimized regimen
alone,
-- that Selzentry along with an optimized background regimen significantly
increased CD4 cells as compared to patients receiving optimized
background regimen alone, and
-- that patients receiving Selzentry experienced similar adverse events to
those receiving an optimized regimen alone.

Monogram's phenotypic resistance tests were used to optimize background therapy in Selzentry's clinical trials.

Selzentry is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Currently available in the U.S., Selzentry is the first drug in a new oral class of HIV medications to be approved in more than ten years. Selzentry (Maraviroc) is under review with European regulatory authorities and recently received a positive opinion from the CHMP.

Selzentry and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools, such as Trofile, are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.

About Trofile

Trofile is a patient selection co-receptor tropism assay that determines which co-receptor a patient's HIV strain or strains use for viral entry- CCR5, CXCR4, or a combination of CCR5 and CXCR4. Which of these "cellular gateways" that a particular HIV strain uses to gain entry into a healthy CD4+ cell is known as the patients "tropism." Trofile amplifies a patient's HIV genome (from their blood sample) to make HIV particles specific to that individual patient. The resultant HIV particles are then used to infect CCR5- and CXCR4- expressing cell lines. Once the virus infects the cell and undergoes its single round of replication, a reporter gene expresses its indicator gene (luciferase), giving a visible signal-thus identifying the patient's viral tropism. Viral load must be at least 1000 copies/mL to determine a patient's viral tropism.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a trademark of Pfizer Inc.


Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: [phone] Tel: [phone]
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com




Source: Monogram Biosciences, Inc.



.

[steviee]

At this point your guess is as good as anyones.

[Neilbaby]

FDA approval and this thing doesn't move. Where do you think the medicare news takes us?

[steviee]

7:21AM Mortgage Applications (BONDX) : The weekly MBA mortgage applications index were down -4.0% last week, with purchasing applications lower by -4.0% and refis dropping -4.2%. The fixed 30-yr mortgage rate was down at 6.41% while the 15-yr edged fell to 6.10%. The 1-yr adjustable rate mortgage rate rocketed to 6.51% from 5.84%, the largest single month jump in that detail since it began being compiled in 1996, according to Bloomberg.

[steviee]

Briefing.com...Lazard plugs MGRM for 2H07 (11 Ratings) 24-Aug-07 10:35 am
MGRM Monogram Biosciences' oncology franchise will garner increased attention in 2H07 - Lazard (1.68 +0.01)

Lazard says that following maraviroc's FDA approval and tropism testing mentioned on the label, all that is left for current HIV catalysts are the sales execution of maraviroc and Trofile. Firm believes MGRM's oncology franchise will garner increased attention in 2H07. Following the positive early data that was presented at A.S.C.O in June, firm looks forward to upcoming oncology assay catalysts: 1) additional VeraTag data, 2) scientific journal publications, and 3) corporate oncology partner announced. They believe MGRM's opportunity to secure oncology collaborations should surpass those it has in HIV.
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[steviee]

Monogram Biosciences to Present at the Thomas Weisel Partners Healthcare Conference 2007
Thursday August 23, 7:00 am ET

SOUTH SAN FRANCISCO, Calif., Aug. 23 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) announced today that William D. Young, CEO and Chairman, is scheduled to present a corporate overview at the Thomas Weisel Partners Healthcare Conference 2007 on Wednesday, September 5, 2007 at 3:15 p.m. (Eastern Time) at the Four Seasons Hotel in Boston, Massachusetts.

To access the live audio broadcast or the subsequent archived recording, log on to http://www.monogrambio.com and go to the investor relations section ("Investors/Media" tab) and click on the "Events & Webcasts" link provided on the sidebar menu on the page.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.

Contacts: Alfred G. Merriweather
Chief Financial Officer
Tel: [phone]
[e-mail]

Jeremiah Hall
Feinstein Kean Healthcare
Tel: [phone]
[e-mail]

[steviee]

http://www.phgfoundation.org/news/

[Ddog]

I haver never saw a good r/s. The pps goes up at the point the r/s happens but the brokers freeze trading because they know there will be a big sell off. When trading resumes the price drops like a rock. I hope you don't have to go through that. Good luck.

[Heedapeeker™]

Thanks Dog! MGRM is looking good (especially yesterday).

I'm looking for an exit point though, because there's talk of a R/S. I dunno about anybody else, but every R/S I've ever been through has cost me $.

GL to all who brave the R/S storm. I hope it pays off in spades for you!!

[Ddog]

Heedapeeker I hope everthing works out for you on Monogram.
Thanks for the private message I didn't know all that happened. I am obviously a cheap so and so(HA HA) or I could reply privatley. Thanks again.

[gibson99]

anyone listen to the CC? Any feedback? Thank you in advance.

[rob1]

Maraviroc approved
http://biz.yahoo.com/prnews/070806/nem068.html?.v=16

Let's hope we get a decent gain and hold onto it.

[mkendra]

I don't like reverse splits. I'm standing back for awhile.

[Increasecometh]

Finally, something to get excited about. This means the OS will be between 20 to 30 million correct? Depending on whether it's 4:1, 5:1 or 6:1. This will make the SP more volatile, which may not be good for a stock with a less bright future than MGRM, but at this stage in the game I think it will do us all a service. It also allows investment funds that won't touch stocks under $5 a chance to invest in us. I see forward splits coming within a year of the reverse split talked about for September as Trophile assay and Veratag (formerly e-tag) generate revenues in the US and abroad. I'm surprised AH is not up but who cares tomorrow is my BDAY and I predict green for us. The nasdaq was down 48 today and we stayed even. I'll take that anyday. One last thing, the short position in MGRM decreased by 50% this month from 12 mil. to 6 mil. Go figure, not much of a gain in share price to reflect that but then again there was no movement in sp when the 13 mil shares traded AH for "reconstitution" either. GLTA

[Heedapeeker™]

Form 8-K for MONOGRAM BIOSCIENCES, INC.

26-Jul-2007

Results of Operations and Financial Condition, Other Events, Financial



Item 2.02. Results of Operations and Financial Condition.
On July 26, 2007, Monogram Biosciences, Inc., or Monogram, issued a press release announcing its unaudited financial results for the quarter ended June 30, 2007. A copy of this press release is included herewith as Exhibit 99.1.





Item 8.01. Other Events.
On July 26, 2007, Monogram announced that it will file with the Securities and Exchange Commission a preliminary proxy statement regarding its annual meeting of stockholders, to be held on September 19, 2007. Included in the matters to be voted on is the approval of a series of alternative amendments to Monogram's Amended and Restated Certificate of Incorporation, as amended, to effect, at the discretion of the Board of Directors, (i) a reverse stock split of the Common Stock whereby each outstanding 4, 5, or 6 shares would be combined, converted and changed into one share of Common Stock, and (ii) related reductions in the authorized number of shares of Monogram's Common Stock.

The effectiveness of one of such amendments and the abandonment of the other amendments, or the abandonment of all amendments as permitted under
Section 242(c) of the Delaware General Corporation Law, would be determined by the Board of Directors prior to Monogram's 2008 Annual Meeting of Stockholders.

[mkendra]

Putting out that PR about the Pfizer comment just before the earnings report scares me a little. Why didn't they just wait, it wasn't THAT important?

Earnigs out at 4:30 pm EST.

[Increasecometh]

Today 7/26/07 is put up or shut up time IMO. Give us some guidance on Maraviroc assay test and etag breast cancer. Who cares about earnings as they will lose .06 again more than likely. With guidance comes future earnings=pps go up!

[Heedapeeker™]

This labeling issue . . .

is really pissing me off.

If we see a PPS drop on earnings, which I think we will, I'm gonna start flipping this thing. Given that you can buy it before the close on a daily basis - in the 1.60's and sell it 2-3 days later in the 1.70's - it just makes since. Still going to keep my core position tho.

GLTYA

[Increasecometh]

Well, let's hope this week is the start of a serious uphill chart. July is just about over with after this week and labeling issues were to be resolved by then. Earnings could be a surprise on Thursday but that should be a ho hum event as -.06 is expected I believe.

[steviee]

EU gives positive opinion on Monogram, Pfizer's HIV drug
By Sarah Turner
Last Update: 6:09 AM ET Jul 20, 2007

LONDON (MarketWatch) -- Monogram Biosciences Inc. (MGRM :
monogram biosciences inc com

MGRM1.75, +0.06, +3.6% ) said that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization of collaborator Pfizer Inc.'s (PFE :
Pfizer Inc

PFE24.99, -0.14, -0.6% ) investigational HIV medication Celsentri (maraviroc). A final decision from the European Commission, which has the authority to approve medications for the European Union, is expected within months. If approved,

[Increasecometh]

MGRM is trading in way too tight of a range lately. 1.64 is very near the bottom as the late selling at the end of day suggest someone trying to scare shares out of weak hands. 1.73 is the highest we've seen in a while but not worth selling at IMO. Not with labeling issues nearly done and a potential huge upside to come. HMMM

[Increasecometh]

From what I have heard and read good news came from this conference as indicated by AH +.03. Labeling issue involved working on the insert of the packaging. Maraviroc is approved and the trophile assay is the only one that will be used...end of story. No Dendreon here get ready for green days to come.

[steviee]

SOUTH SAN FRANCISCO, Calif., June 25 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) announced today that William D. Young, CEO and Chairman, is scheduled to present a corporate overview at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference on Wednesday, July 11, 2007 at 3:00 p.m. (Eastern Time) at the Mandarin Oriental Hotel in New York City, New York.
To access the live audio broadcast or the subsequent archived recording, log on to http://www.monogrambio.com and go to the investor relations section ("Investors/Media" tab) and click on the "Events & Webcasts" link provided on the sidebar menu on the page.

[Increasecometh]

Mgrm have you foresaken me too? Why do all the stocks I buy go down?

[Heedapeeker™]

Me too.

[Increasecometh]

I think it's going up from here not down.

[Heedapeeker™]

The Russell shuffle was indeed the culprit. Personally, I thought the PPS staying at 1.67 was a good thing!

Why do you think the PPS is going to tank now, if it didn't after over 8M shares traded on Friday?

[Increasecometh]

Wow! No post over the weekend about the crazy volume on Friday huh? Russell index shuffeling shares around sounds like a lame excuse to me. How could we end up where we started after 15% of the float traded in 1 day. 1.67 will be just a memory by the end of the week.IMO

[bpk4027]

What do you think Slick?
bpk

[steviee]

My my, where next

[bpk4027]

Well good point

No,
I am in this for the long haul. It does not have the chart to support day trading. CHCG does but anyway. I knew this company was going to be down at least 10% today. If it goes below 1.50 there will be even more of a sell off It she goes to 1.50, she'll end up at 1.25.
bpk

[steviee]

ss = sell short

[bpk4027]

Shares Short?
Is that what you mean?
Yes it is over 13,000,000 short. And has been for 4 monthes since early March. That does not mean anything right now, because the ones that are shorting are no being forced to cover. Look at the due dates, Look close. Then look next week. They will be rolled into July, why? I don't know. If they had to cover this would be at 5 bucks, not dicking around 1.60 like it has been for a year.
bpk

[steviee]

With such insight u should ss.

[bpk4027]

She's going to drop

Good morning everyone it has been awhile. I'm still in but she's slow, we would've seen 3 buck if the news was the other way. She'll be down to a buck 55 today.
bpk

[mkendra]

So...........the question is:

Is the glass half empty, or half full?

Based on pre-market activity today, the news is not being taken well. MGRM and PFE are both down pre-market. PFE has other problems, as well.

I don't know - this could be a buying op.

If this drops 30 cents or so, I might pick up a little more.

If not, I watch and wait.................

Thought, anyone?

[Heedapeeker™]

June 20 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, failed to win U.S. approval for maraviroc, the first new type of medicine in a decade to treat the virus that causes AIDS.

Pfizer is working with the Food and Drug Administration on changes the agency sought on the product's labeling, the company said in a statement today. The FDA didn't ask for any further studies, said Ray Kerins, a Pfizer spokesman, in an interview. He declined to specify what label issues were under discussion.

Full article: http://www.bloomberg.com/apps/news?pid=conewsstory&refer=conews&tkr=PFE:US&sid=al26g9eKl...

[steviee]

eggs

[forgreen]

It is an approvable letter. Meet the terms and you are approved. It is now just a market game of timing that for some. Others are actually calm because they know approval is in the pipeline for Maraviroc.

[steviee]

Pfizer Says FDA Asks for More Information on Its HIV Drug Candidate Maraviroc Wednesday June 20, 5:56 pm ET


NEW YORK (AP) -- Drug developer Pfizer Inc. said Wednesday the Food and Drug Administration asked the company for more information on its HIV treatment candidate maraviroc, which is under regulatory review.
ADVERTISEMENT


A Pfizer spokesman said the company is working to answer additional questions the FDA sent in an approvable letter. The questions will not require new clinical trials, the spokesman said.

The drug candidate is aimed at treating patients infected with CCR5-tropic HIV-1 who have become resistant to one or more currently available treatments.

More than 2,000 patients worldwide have received the drug candidate through clinical trials, Pfizer said.

Pfizer also said it established an expanded access program for maraviroc in 30 countries. The program is a clinical study that makes the drug candidate available to patients in countries where they have limited treatment options.
http://biz.yahoo.com/ap/070620/pfizer_ma...

[forgreen]

Market adoption of MGRM services. Very strong news. Will add to the bottom line. State by state, MGRM will enter the mainstream of modern medicine.

[forgreen]

Look at the big picture here. This is not a day trading stock for most people.

[mkendra]

Pre market looking good!

[steviee]

Medi-Cal Expands Coverage of Baseline HIV Resistance Testing
Monday June 18, 6:31 pm ET
Monogram Spearheads Effort to Improve Disease Management for All HIV Patients and Physicians

SOUTH SAN FRANCISCO, Calif., June 18 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) announced today that Medi-Cal has expanded its coverage of HIV resistance testing to include treatment naive patients as well as patients failing therapy. While genotypic resistance testing has traditionally been covered for patients who fail anti-HIV treatment, the expanded coverage allows for baseline genotypic resistance testing for all HIV infected patients, including those who are newly diagnosed and who are treatment naive. Medi-Cal is California's Medicaid program, which provides medical service coverage for low-income and disabled individuals.

ADVERTISEMENT
This coverage expansion was driven by scientific evidence that documents an increasing prevalence of patients who become infected with drug resistant virus: up to 16% in some geographic areas. Drug resistant virus may persist during the pre-treatment phase of HIV infection. The BGRT identifies anti-HIV drugs likely to be ineffective, when treatment becomes necessary, even when begun months or years later. Evidence shows BGRT guided initial therapy results in longer time of viral suppression.

The evidence was compiled by physician experts whose efforts were supported by Monogram Biosciences and advocates working to better the lives of patients living with HIV. Guideline recommendations from a antiretroviral guidelines Panel convened by the Department of Health and Human Services, Office of AIDS Research Advisory Council and the Henry J. Kaiser Family Foundation documents scientific evidence that supports expanding BGRT coverage to include chronically infected HIV treatment naïve patients. Specifically, the Panel recommended performing BGRT prior to initiating antiretroviral therapy in patients with acute or chronic HIV infection.

"We applaud Medi-Cal for setting coverage policies designed to bring personalized care to patients infected with HIV." says Tien Bui, Monogram Vice President of Medical Affairs. "Medi-Cal's coverage expansion is an important step towards ensuring that HIV patients and their physicians across California can make the best, most informed treatment decisions possible."

For more information on the New Policy and Frequency Restrictions for HIV Drug Resistance Testing please visit the following section of the Medi-Cal website: http://files.medi-cal.ca.gov/pubsdoco/publications/bulletins/ob/obbull_e.asp

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that regulatory authorities may not require a molecular diagnostic for patient selection for an HIV drug, risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Co-Receptor Tropism Assay for patient use in the event of approval of any CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc.

Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: [phone] Tel: [phone]
[e-mail] [e-mail]


Source: Monogram Biosciences, Inc.

[mkendra]

http://quote.barchart.com/texadv.asp?sym=MGRM

[Tina]

Let's see $2 today!