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I think what happened is that the stock was diluted, and that pushed the stock price down, when MAbcure recently converted a $500,000 bridge loan into equity securities. The capital will be used by MabCure to pursue its clinical trials in Europe and Asia. See below press release on 3/8/2010.
I think the stock will stay at these levels until Mabcure announces the results of the first clinical trial of
anti-ovarian MAbs or other significant news. They are in initial stage development of their products, and it will take some time for the products to come to market and for the stock to really take off. But if they are successful the rewards will be awesome. So I intend to stay invested for the long run.
For your information, there is another OTC company, Arrayit (ARYC) that is in late stage production of ovarian cancer diagnostics tools and they are hoping to submit application for FDA approval in the 2nd quarter of 2010.
-----------------------------------
3/8/2010 Mabcure press release:
MabCure Completes a Private Placement in the Aggregate Amount of $1 million
MabCure, Inc. (OTCBB:MBCI) (“MabCure”), a biotechnology company using its proprietary technology to create highly specific monoclonal antibodies (MAbs) for the early detection of cancer, today announced that it has recently completed a private placement in the aggregate amount of $1 million. The amount is comprised of a $500,000 cash investment and the conversion of a $500,000 bridge loan that was made in September 2009, into equity securities (together, the “Investment Transactions”).
Under the terms of the Investment Transactions, MabCure will issue 2,000,000 units to the investors at a price of $0.50 per unit. Each unit consists of: (i) one share of MabCure common stock; (ii) one two-year non-transferable common stock purchase warrant exercisable at a price of US$0.60 per share; and (iii) one two-year non-transferable common stock purchase warrant exercisable at a price of US$0.70 per share.
The new investment capital will be used by MabCure to pursue its clinical trials in Europe and Asia. Clinical trials to diagnose ovarian cancer are already underway after MabCure signed a clinical research agreement with the Ramathibodi Hospital, Mahidol University in Bangkok, Thailand. The study aims to evaluate MabCure’s panel of anti-ovarian MAbs in diagnosing ovarian cancer in the blood and urine of patients suspected of having the disease.
Dr. Amnon Gonenne, MabCure’s president and CEO commented, “We are very pleased to close this private placement and to convert our bridge loan into equity securities, particularly during challenging times for raising private equity. The funds will provide us with the near-term liquidity we need to sustain our clinical trials program and to grow the business.”
Bart, I see your point. Let's wait and see what (if anything) Arrayit's management does in the next few days to continue the momentum.
Bart and Silver, I think the marketing campaign worked in so far as it developed excellent investor awareness of the company and its potential. Up until now the stock was largely unknown by the investment community, and the stock traded just a handful of shares daily. Since the campaign started last weekend, close to 2 million shcares have been traded, and there has been a lot of buzz in the investment community.
It was clearly stated in the campaign that:
- application for FDA approval of OvaDx™ was expected in the 2nd quarter of 2010 via DOCRO and that DOCRO has a 99% success rate with FDA.
- upon FDA approval, OvaDx™ should have rapid adoption,accelerating revenue and earnings growth.
- Arrayit is Undervalued
The way I see it, the main event that has to happen is FDA approval application and then (hopefully) fast track FDA approval.
Price per share last Friday was 0.80, now is about 1.00 a 25% increase. But, we can't expect the stock to soar much beyond the $1.00 per share until FDA application and then approval. Investors have to be PATIENT.
Silver, I'm glad to hear of your assessment that Arrayit's "core business is fundamentally sound" and that the stock is probably a buy at these levels. This gives me more confidence about investing in this stock since you were the main skeptic on this board.
In this article they discuss the false-positive and false-negative issues with OVADX. It does not seem to be a show stopper.
From clinica.com.uk
Arrayit hopes to thwart "silent killer" with first ovarian cancer blood test
By Madeline Armstrong
January 15, 2010
Ovarian cancer is dubbed the "silent killer" because its unspecific symptoms often mean that patients are diagnosed with late-stage disease with a poor prognosis. Madeleine Armstrong spoke exclusively to Mark Schena, president of Arrayit, a company that is planning to change this with what it hopes will be the first ovarian cancer screening test, OvaDx
Ovarian cancer is the fifth leading cause of cancer death in women and the most deadly gynaecological cancer. It is often diagnosed at an advanced stage, meaning that the prognosis for most patients is grim – the five-year survival rate for late-stage disease is only around 20%. However, if it is diagnosed and treated while in its early stages, this could rise to over 90%.
Currently, only 20% of cases of the disease are diagnosed at an early stage. One of the problems with trying to increase this figure is that ovarian cancer symptoms are unspecific and common in many women without the disease. These include abdominal pain, discomfort or bloating, urinary frequency and abnormal vaginal bleeding.
Currently, there is no diagnostic test to screen for the disease: Vermillion and Quest Diagnostics' OVA1 is used to help determine whether women with a pelvic mass are likely to have ovarian cancer; while LabCorp has stopped selling its blood test OvaSure, which was designed to detect early-stage disease in high-risk women, after being criticised by the US FDA for launching it without regulatory approval (www.clinica.co.uk, November 13 2008).
CA125 is a known biomarker for ovarian cancer, but its use is limited by the fact that it may also be elevated in other cancers and benign conditions such as endometriosis. Its role in the early diagnosis of ovarian cancer is therefore controversial, and it is probably more useful for monitoring patients for recurrence rather than as a screening tool.
Microarray specialist Arrayit plans to remedy this situation with an ovarian cancer blood test, OvaDx, which is in late-stage development. The Sunnyvale, California firm is currently refining the test, and hopes to submit it to the US FDA in the second quarter. Approval could follow by as early as the fourth quarter of 2010. "We hope to get it reviewed on an expedited basis, as there is such an unmet need," Arrayit's president, Mark Schena, told Clinica. The company plans to CE mark the test for sale in Europe after US approval.
OvaDx is different than other available tests because it could be used for screening programmes in the general population, similarly to Pap screening for cervical cancer, which has dramatically reduced mortality from that disease. Like cervical cancer, ovarian cancer is quite easy to treat in its early stages, Dr Schena explained. "The procedure to remove an ovarian mass is relatively noninvasive. It's not quite an outpatient process, but for early-stage disease it's very close to that."
Arrayit hopes that its test could "nip ovarian cancer in the bud". It can detect an ovarian tumour that is around half a centimetre in diameter, Dr Schena said. In comparison, late-stage tumours (stage III/IV) can weigh from half a kilogram to several kilograms.
OvaDx only requires a few drops of blood, so could be added to a regular health check. "We would recommend that high-risk women and those over a certain age be tested annually, while average-risk younger women could be tested every few years," he said. Arrayit is currently looking into the age limit for yearly testing, but thinks the threshold would probably be around 50 years.
The test is based on over 100 protein biomarkers that are upregulated during the body's immune response to a tumour. "The test works by measuring markers produced by the immune system in response to early-stage ovarian cancer," Dr Schena explained.
In studies that have been carried out to date, in up to 1,000 patients, there have been no false-positive results, he said. "There have been several false negatives, but we expect this to be very low once we've refined the test." Although this means there is a slight risk of missing cases of cancer, Dr Schena pointed out that this was better than the current alternative – nothing.
As for the risk that a false positive could lead to unnecessary surgery, he was adamant that this would not be the case: "We would recommend that any positive result with OvaDx be confirmed with another technique such as ultrasound. Until then, patients should not undergo any treatment or surgery." Ultrasound would also help pinpoint the location of the mass and its size to aid surgical procedures.
Arrayit is also working on tests for the early diagnosis of other diseases such as Parkinson's and prostate cancer. But in the meantime it is "very excited about bringing this rather revolutionary ovarian cancer test to the market", Dr Schena said.
It might not be the only one: earlier this month, MabCure started a trial to evaluate monoclonal antibodies in ovarian cancer, which it hopes will be used for early diagnosis (www.clinica.co.uk, January 7). The company did not release many details about its diagnostics, and it appears to be in early-stage development.
Whether either or both tests succeed, it looks like there will soon be a screening test for ovarian cancer – potentially silencing the silent killer.
For whatever it is worth from TheMarketFinancial.com
Arrayit Corp Nears FDA Filing For Ovarian Cancer Diagnostic Screening Test
Written by Michael Vlaicu
4/30/10
Arrayit Corp (OTC:ARYC) could generate strong upward movement into the coming 510(k) New Medical Device submission, which could come at any point now. Subscribers at TheMarketFinancial.com should be well aware of our last over-the-counter penny stock alert, Cambridge Heart (OTC:CAMH), which went from $0.15 per share to $0.60 on 510(k) approval of their MTWA used to measure a patient’s risk of cardiac arrest. However, when noticing the vast array of products it has to offer, a comparisson to Nephros (OTC:NEPH) would be more appropriate, which saw its shares rise from $0.10 to well over $2.00 on 510(k) approvals.
OvaDX is a Pre-Symptomatic Ovarian Cancer Diagnostic Screening Test. Arrayit announced one month ago that they had appointed contract research organization DOCTRO to assist in obtaining FDA marketing clearance for OvaDx. Guidance was provided in mid April for a new medical device filing with FDA during the late 2Q10 to early 3Q10, in which Arrayit is also expected to close one or more round of financings.
John Howell, CEO of Arrayit Diagnostics, Inc., added, “With plans to market the test at a cost of approximately $350 per test kit and presuming we achieve our predetermined time-to-market objectives, we are confident that revenue of $4-$5 million is an attainable sales goal for 2010. Moreover, given that we estimate the total market for a viable early stage ovarian cancer screening test in the U.S., Japan and Europe could collectively represent use of up to 175 million kits per year; beyond 2010, annual revenues for Arrayit Diagnostics could ultimately reach into the hundreds of millions, and perhaps even billions, of dollars.”
Ovarian cancer presents with largely non-specific symptoms during its initial stages of progression, however there is currently no adequate screening or diagnostic test for early stage detection. As a result, most ovarian cancers are diagnosed only when later stage symptoms manifest and the disease has metastasized to other parts of the body. Consequently, the five-year survival rate for late stage diagnosis is less than 20%, which compares to an approximate 90% survival rate if the disease is identified at the earliest stages. According to the National Cancer Institute, it is estimated that 21,550 women will be diagnosed with and 14,600 women will die of cancer of the ovary in 2009 in the United States. Moreover, based on rates from 2004-2006, 1.4% of women born today will be diagnosed with ovarian cancer at some point during their lifetime.
Disclosure: Long ARYC
TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.
http://www.themarketfinancial.com/arrayit-corp-nears-fda-filing-for-ovarian-cancer-diagnostic-screening-test/2407
The way I see it, penny stocks and start up companies are inherently very risky. There are thousands of new companies trying to make it, and many of them will fail. When you invest in them you have to be prepared to lose all or most of your money. If one can’t afford to lose one's money, don’t invest in risky companies. And never invest more than 5% of your total portfolio in risky investments.
But then for the rewards - IF the company succeeds, you may have a windfall. And from what I have read, Arrayit has a potential game changer with OVA Dx diagnostic test since there is nothing like it in the market at present. And application for FDA approval will most likely happen this year. The FDA will decide whether this product is what it is cracked up to be. In addition, there are other potential groundbreaking products in the pipeline in addition to their existing products.
I have not read anything extremely negative or unethical about the company in the press. Most articles give a balance view of the potential versus the risks. But people are entitled to their opinion for or against the company and where it is going. The investor should take all into account and decide what to do.
Here is a list of the Cancer Diagnostic companies that appears in the Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th. Edition. Arayit is listed in the “New Entrants And new creation Developers” category. How many of the new entrants will succeed? Will Arrayit and/or Mabcure (MBCI), another exciting new entrant in the cancer Diagnostic field which is conducting ovarian cancer diagnostic trials in Thailand succeed? Time will tell.
The Top Tier of IVD Companies and their investment in cancer diagnostics
Abbott Diagnostics
Molecular Histology
Molecular Diagnostics
Immunoassays
Beckman Coulter Inc
FOB
Flow Cytometry
Becton, Dickinson and Company (BD)
Histology
bioMerieux Inc
Bio-Rad Laboratories Inc
Dako A/S
Fujirebio Diagnostics, Inc
Gen-Probe Inc
Hologic, Inc
Histology
HPV
Inverness Medical Innovations
Ortho Clinical Diagnostics
QIAGEN N.V
Roche Diagnostics Indianapolis, IN www.roche.com Recent Revenue History ($ million)
Histology
Immunoassays
PCR
Research
Siemens Medical Solutions Diagnostics
Molecular
In Vivo
Sysmex Corporation
The Status Quo in Cancer Diagnostics
AdnaGen AG
Agendia BV
AMDL Diagnostics, Inc. (ADI)
American Diagnostica Inc
Aperio Technologies, Inc
Asuragen, Inc
AviaraDx
protection Site (The) Ltd
BioCurex Inc
BioGenex Laboratories, Inc
BioImagene
Bio-Reference Laboratories, Inc
Biotage AB
bioTheranostics
BioView Ltd
Celera Diagnostics
China Medical Technologies, Inc
Cisbio Bioassays
Clarient Inc. (formerly ChromaVision)
Clinical Data, Inc
CytoCore, Inc
DxS Ltd
Epigenomics AG
Genetix Applied Imaging
Genomic Health, Inc
Genzyme Genetics
Health Discovery Corporation
HistoRx, Inc
Ikonisys, Inc
InterGenetics Inc
Ipsogen SA
Lab21 Healthcare
work Corporation of America Holdings (LabCorp)
Life Technologies
Monogram Biosciences, Inc
mtm laboratories AG
Myriad Genetics, Inc
Nanosphere, Inc
OncoVista Innovative Therapies, Inc
Pathwork Diagnostics
Precision Therapeutics
Titan Laboratories Inc
Quest Diagnostics
Response Genetics, Inc
Rosetta Genomics Ltd
Sequenom
Transgenomic Inc
Veridex, LLC
chromatic Inc
Zila, Inc
New Entrants And new creation Developers
20/20 GeneSystems, Inc
454 Life Sciences Corporation
Acrometrix Corporation (Life Tech.)
Acupath Laboratories, Inc
Advalytix
Affymetrix, Inc
Allegro Diagnostics
Althea Technologies, Inc
Amorfix Life Sciences Ltd
Arbor Vita Corporation
ArcticDx Inc
Arrayit Diagnostics Inc
AVEO Pharmaceuticals, Inc
Axela, Inc
Baypoint Biosystems, Inc
Biodesix, Inc
Biologix Diagnostics, LLC
BioMarker Strategies, LLC
Biomoda
BioMosaics
BioProspecting NB, Inc. (BPNBI)
BioServe
Biosystems International SAS (BSI)
BioTrove, Inc
Cambridge investigate & Instrumentation, Inc. (CRi)
Cangen Biotechnologies, Inc
Caris Diagnostics
Castle Biosciences Inc
Celerus Diagnostics
Cell Biosciences
CeMines, Inc
Cepheid
ChromoCure Inc
Chronix Biomedical Inc
Clinical Genomics Pty Ltd
CombiMatrix Molecular Diagnostics (CMDX)
broad Cancer Cell (CCC) Diagnostics Inc
Compugen Ltd
Correlogic Systems, Inc
CS-Keys, Inc
deCode Genetics Inc. —
DiaGenic ASA
DiagnoCure –
Diagnoplex
Diagnostic Biosystems Company
DNA Direct, Inc
DexTerity Diagnostics
EDP Biotech Corporation
Epistem Plc
Exact Sciences Corp
Exiqon A/S
ExonHit Therapeutics
Exosome Diagnostics Inc
Expression Pathology Inc
Falcon Genomics, Inc
FASgen Diagnostics, LLC
Fluxion Biosciences
Foligo Therapeutics, Inc
Gastrocor
Genelex Corporation
GeneNews Limited
Genoptix
iKaryos Diagnostics
Illumina
Inostics GmbH
InteRNA Technologies B.V
Intrinsic Bioprobes Inc
Invirion Diagnostics, LLC
InVivoScribe Technologies
stop BioTechnologies Inc
stop International, Inc
MabCure Inc
MacroArray Technologies, LLC
MagArray Inc
Martell Biosystems, Inc
Med BioGene, Inc. (MBI)
Medical Prognosis Institute
Metabolon, Inc
Miraculins Inc
MolecularMD Corp
Neogenix Oncology, Inc
NextGen Sciences
Nuvera Biosciences
Olink AB
Oncimmune LLC
OncoMethylome Sciences S.A
On-Q-ity
Orion Genomics
Oxford BioTherapeutics
Pacific Edge Biotechnology Ltd. (PEB)
Photocure ASA
Power3 Medical Products, Inc
Prediction Sciences
Predictive Biosciences
PrognosDx Health, Inc
Provista Life Sciences LLC
Rubicon Genomics, Inc
Rules-Based Medicine, Inc. (RBM)
Saladax Biomedical, Inc. (SBI)
SensiGen LLC
Sienna Cancer Diagnostics
mode Genomic Laboratories, LLC
Singulex Inc
Skyline Diagnostics B.V
Source MDx
Soar BioDynamics, Ltd
Strategic Diagnostics Inc
Synergenz Bioscience Ltd
Targeted Molecular Diagnostics (TMD)
Theranostics Health (TH)
TrimGen Corporation
TrovaGene, Inc
Vitatex Inc
WaferGen Biosystems, Inc
Xceed Molecular (formerly MetriGenix Corporation)
Zetiq Technologies Ltd
Feature about Arrayit litigation from DOTmed News
Pediatrix Gets New Trial in TeleChem (now Arrayit) Litigation
April 27, 2010
by Astrid Fiano, DOTmed News Writer
Pediatrix Screening, Inc. of Bridgeville, Pa., has won a new trial in a recent decision by the Third Circuit appellate court. Pediatrix and TeleChem International of Sunnyvale, Calif. had been in litigation over two contracts that developed from Pediatrix proposals regarding experimental microarray technology, including preparing a grant application to the National Institutes of Health, and a study to develop a microarray screening process for several genetic disorders. According to court documents, TeleChem had agreed that all grant money would go to Pediatrix and that TeleChem would devote commitments of personnel, research, equipment and supplies. TeleChem (now Arrayit) provides technical assistance and hardware for use in microarray technology for genotyping. Pediatrix (now PerkinElmer) provides genetic screening of infants.
As the appellate decision recounts, the two companies had agreed to set up a joint corporation--NGS-ArrayIt--although Pediatrix did not actually file the documents with appropriate authorities. TeleChem later accused Pediatrix of breach of contract, and then Pediatrix filed the suit in question a few days later in November 2001, also asserting breach of contract. TeleChem then filed a counterclaim, asserting breach of contract and tort actions in fraudulent misrepresentation and misappropriation of trade secrets.
At trial, the jury in this case had found that for the contracts under dispute, TeleChem had breached one, for which Pediatrix was awarded nominal damages, Pediatrix and TeleChem had breached the second, in which both were awarded $1 million in liquidated damages, and Pediatrix was liable for fraudulent misrepresentation, for which TeleChem was awarded $500,000 in compensatory and $3.5 million in punitive damages. The claims for misappropriation of trade secrets were nullified. The Third Circuit has allowed a new trial on the misrepresentation claim.
In the appellate court's opinion, the principal issues were if Pediatrix had preserved the misrepresentation question for appeal, and whether the trial court had erred in the legal ruling that allowed tort recovery for conduct (misrepresentation) that could also be breach of contract. The question of whether a case is a tort or contract case falls under the "gist of the action" doctrine. This doctrine prevents a plaintiff from construing a breach of contract case as a tort claim. To be construed properly as a tort, the complained-of action must be the "gist" of the action, and the contract only collateral to the action. Pennsylvania law, which controls this diversity action, states that if fraud claims are "inextricably intertwined" with contract claims, the gist of the action is contractual, and any tort fraud claim should be dismissed.
The appellate court found that Pediatrix had properly preserved the issue for appeal. The court also found TeleChem's characterization of the misrepresentation to be vague, as TeleChem's counsel had stated at different times that the misrepresentation was that TeleChem would benefit commercially from a grant collaboration or that it was fraudulent inducement of TeleChem to enter into the relationship in the first place. Therefore, too much uncertainty was in the record as to whether the misrepresenation was collateral with the first contract or was inextricably intertwined with the parties' actions in the collaboration, so the trial court erred in its disposal of the misrepresentation question. The appellate opinion pointed out that the trial faced difficulties in both parties changing counsel as well as two reassignments of judges, in addition to the complicated technical questions over the trade secrets. The court then ordered a new trial for the counterclaim of misrepresentation.
http://www.dotmed.com/news/story/12462/
Good to see the price went up 33% to 0.40 today at the opening in heavy volume. It'd be nice if the Mabcure Corporation made some kind of positive press release or announcement to perk up more buying interest in the stock.
What's going on with MBCI?
Does anyone know?
The stock has been trading in very heavy volume over the last couple of days, but the price went down 30% today at the last 10 minutes of trading. From 0.43 to 0.30 (all time low) Volume 102,216
genomeweb article on Arrayit
Arrayit Posts Flat FY '09 Revenues, Rolls Out Antibody Screening Arrays, New Instruments
April 20, 2010
By Justin Petrone
Arrayit last week said that it has made "significant progress" in its efforts to develop and launch pre-symptomatic tests, expand its microarray services, and introduce new instruments.
Specifically, CEO Rene Shena cited a recent agreement with contract research organization Docro to help prepare its OvaDx ovarian cancer test for submission to the US Food and Drug Administration for clearance later this year (BAN 3/23/2010).
Arrayit President Mark Shena noted in the statement that the firm has also made "important progress" to expand its biomarker discovery and validation services.
Still, the Sunnyvale, Calif.-based array company said its growth has been "frustrated" by a lack of capital and inability to meet orders, and that it expects to close one or more rounds of financing during the second quarter of this year.
"The company is pursuing growth capital to meet these objectives from several sources," Arrayit said in a statement. The firm also improved its balance sheet by retiring approximately $3.5 million in debt through equity conversion over the past few months, "further positioning the company for new investment."
Arrayit's lack of access to capital took a toll on its financial performance last year. As the firm reported in a recent filing with the US Securities and Exchange Commission, its revenues for the year ended Dec. 31, 2009, declined 1.7 percent to $4 million from $4.1 million in the prior-year period.
"Revenues remained virtually constant as our lack of financing hampered us in our efforts to accept more orders," Arrayit said of its performance.
Net loss in 2009 swelled 368 percent to $8.9 million from $1.9 million in the prior-year period.
Arrayit incurred a large non-recurring loss on derivative liability following its combination with Integrated Media Holdings in March 2009, through which it became a publicly traded firm.
Despite going public last year, Arrayit has "been frustrated in its ability to raise capital." In the SEC filing it said that if it is unable to complete licensing agreements for its diagnostic technologies, or raise $3 million in capital, it will be unable to pursue its business strategies.
"In the long term, [Arrayit] will need significant amounts of net cash to fund its research and development, to provide working capital and to repay its debt," the company said. "Failure to raise new capital will severely impact the company’s ability to complete its business plan."
Arrayit added that should it not be able to raise such funds, it will need to reduce expenses by "laying off staff and curtailing development." As of Dec. 31, 2009, Arrayit had 10 full-time employees and four part-time consultants.
Arrayit has been spending more to realize its transition from a firm that sells arrays and equipment for research purposes into a molecular diagnostics company. In August 2009 it established its Arrayit Diagnostics subsidiary in Houston to launch tests as they become available. In addition to its ovarian cancer program, Arrayit also has diagnostics for Parkinson's and Alzheimer's diseases in development (BAN 8/18/2009).
Specifically, the firm has an ongoing collaboration with the Parkinson’s Institute in Sunnyvale, Calif., to identify blood-based biomarkers associated with the disease. Arrayit is also working with Stanford University to identify blood-based biomarkers associated with Alzheimer's disease.
To support these efforts, Arrayit spent $335,100 on R&D last year. The expenditures were "primarily focused on our new diagnostic testing area," Arrayit said. The firm only had "minor expenditures" in 2008 on R&D.
The company ended the year with $1.7 million in net cash.
New Products
While molecular diagnostics remains at the forefront of Arrayit's agenda, the company has also been busy rolling out new products for researchers. Most recently, Arrayit partnered with Paris-based BioSystems International to produce and sell PlasmaScan antibody microarrays.
Paul Haje, Arrayit's vice president of sales and marketing, told BioArray News this week that the company now offers PlasmaScan antibody arrays in 80-antibody or 380-antibody array formats.
Commensurate with that launch, Arrayit began selling a protein array buffer kit that the firm claims can be used with an protein array.
On the instrument side, Arrayit recently rolled out its TrayMix S4 Automated Hybridization Station. The new instrument uses chaotic advection to speed hybridization time while allowing for through-binding of target and probe, Haje said. The hyb station can be used in gene expression, genotyping comparative genomic hybridization, and other array-based applications, he added.
The company also upgraded its SpotBot arrayer to include an improved printhead, software, and visualization system. Arrayit said that it has 339 SpotBots installed worldwide.
Arrayit is also now offering custom printing of proteins and peptides, Haje said. The company is also now making its variation identification platform available to customers who wish to develop and launch genotyping-based diagnostics on Arrayit's chips, Haje added.
http://www.genomeweb.com/arrays/arrayit-posts-flat-fy-09-revenues-rolls-out-antibody-screening-arrays-new-instru
Silver - Can one tell from Depth/LII tab on otcbb.com (or some other place) if the trade was someone buying or selling? Thanks!
Press release from ARRAYIT Corporation this morning titled
"Arrayit Achieves Significant Progress in First Quarter 2010"
In it it says among other things that the company anticipates submittal of the FDA application for OvaDx™ in late second or early third quarter 2010.
Thanks for the info about this tool
I'm not sure what you mean by this, about a 100 share trade at the close yesterday. What I saw is that there was no trading at all day and then between 3 an 4 pm over 27,000 shares were traded.
Thanks for the info JJ and Silverfusion
Where can I find a copy of the 10-K filed 1/31/10?
Your're welcome. I agree it is a lengthy report but a lot of good info here. You may want to read it online without printing it.
I'm not an expert reading these reports, but a few things stood out for me:
Risk Factors related to our Business:
(These are the headers, they give more details about each one in the report)
- We have no operating history and have maintained losses since inception, which we expect to continue into the future
-Our independent auditors’ report states that there is a substantial doubt that we will be able to continue as a going concern
- Our inability to complete our product development activities successfully may severely limit our ability to operate and finance operations
- Clinical trials are expensive, time consuming, and difficult to design and implement, and it is unclear whether the results of such clinical trials will be favorable.....We estimate that clinical trials of our proposed products will take at least several years to complete once initiated.
+ other risks
On the positive side:
Over the next twelve months, we plan to:
complete our Asian clinical study for the diagnosis of ovarian cancer;
initiate additional anti-ovarian cancer multi-center clinical studies;
initiate an anti-prostate cancer diagnosis clinical study;
initiate the anti-breast cancer program, with the objective of creating novel MAbs against this cancer;
initiate the antigen identification program in order to identify and sequence those antigens, or cancer markers, which are recognized by our novel MAbs. The first antigens to be studied will be the melanoma- specific cancer markers through the application of our anti-melanoma MAbs;
and
hire an additional scientist for our Belgian subsidiary to assist in carrying out the tasks described above
10K report - Road Map for Mabcure
Mabcure filed their 10K report today and makes for very interesting reading about the company.
http://www.faqs.org/sec-filings/100324/MABCURE-INC_10-K/
Article published today in Wall Street Journal
"Test to Help Determine If Ovarian Masses Are Cancer"
It is about the $650. OVA1 test, sold through Quest Diagnostics Inc, and will be available for general use Tuesday.
In the article they mention Arrayit:
"Tests for ovarian cancer have proved challenging to develop and gain FDA approval because it is difficult to prove a screening test is accurate. Laboratory Corp. of America in 2008 withdrew its OvaSure screen, designed to find cancer in high-risk women, from the market after the FDA and many physicians questioned its accuracy. Correlogic Systems Inc., Germantown, Md., was originally hoping to develop a test for finding cancer in high-risk women, but now is aiming for a more modest goal of a test with a purpose similar to the OVA1. Arrayit Corp., Sunnyvale, Calif., says it is working on a screening test, but it isn't clear yet if it will pass muster with the FDA."
http://online.wsj.com/article/SB10001424052748704869304575109703066893506.html?mod=googlenews_wsj
Between the clowning around from the interviewers, Dr. Schena said in the radio interview that he expected FDA approval in 2010. And when they asked him where he saw the company in 5 years, he said he could not tell share price wise, but that he envisions it been listed in the NYSE.
During the summer, Arrayit created a subsidiary, Arrayit Diagnostics, to market and sell OvaDx, as well as other tests under development.
John Howell IS the CEO of Arrayit Diagnostics.
Since the subject in question , John Howell, is the CEO of Arrayit Diagnostics , should we be worried?
"During the summer, Arrayit created a subsidiary, Arrayit Diagnostics, to market and sell OvaDx, as well as other tests under development. In the company's statement, Arrayit Diagnostics CEO John Howell said that the plan is to sell OvaDx as a test kit priced at about $350. If it is successful in getting FDA approval by the third quarter, revenue of $4 million to $5 million in its first year on the market "is an attainable goal," he said. After that, the total worldwide market for the test, he told ProteoMonitor, could reach into the billions of dollars."
Source:
http://www.thefreelibrary.com/United+States+:+Arrayit+Readies+Ovarian+Cancer+Dx+for+FDA+OK,...-a0216461116
In this 1/8/10 article in the thefreelibrary.com, it says:
"After a decade of getting its technology up to snuff and creating a business infrastructure for its clinical-diagnostics ambitions, Arrayit last month announced it would be seeking regulatory approval for a protein array-based ovarian cancer test, launching the firm into the diagnostics space.
In a statement announcing its plans, Arrayit said that it intends to file its OvaDx test for early ovarian cancer detection with the US Food and Drug Administration for 510(k) clearance. It added that barring "unexpected delays" in the FDA approval process, the test could be ready for full commercial launch as early as the third quarter, following its launch for research purposes in the first quarter"
McMac: has the timeline changed?
http://www.thefreelibrary.com/United+States+:+Arrayit+Readies+Ovarian+Cancer+Dx+for+FDA+OK,...-a0216461116
MabCure Featured in GenomeWeb
HASSELT, Belgium, Feb 01, 2010 (BUSINESS WIRE) --
MabCure, Inc. (OTCBB: MBCI | Quote | Chart | News | PowerRating) ("MabCure"), a biotechnology company using its proprietary technology to create highly specific monoclonal antibodies (MAbs) for the early detection of cancer, has been featured in a January 14, 2010 article published on GenomeWeb, the largest online news organization focused on advanced research tools in genomics, proteomics, and bioinformatics.
The cover story, written by Tony Fong and titled "MabCure Begins Clinical Trial for Antibody Technology for Use as Cancer Diagnostic," describes the company's "improvement over ... strategies employed by most proteomics companies," which rely on statistical differences in expression of normal proteins that may correlate with cancer. In contrast, MabCure is developing monoclonal antibodies against cancer-specific antigens (markers) which are unique to different types of cancers. In the case of ovarian cancer, MabCure's approach "seeks to detect antigens specific to ovarian cancer in order to diagnose the disease with a high level of certainty."
Highlighted in the piece is MabCure's revamped hybridoma technology which is "...able to generate thousands of antibodies in about four to six weeks" versus classic hybridoma which is capable of generating only a few hundred in four to six months. The article quoted Dr. Amnon Gonenne, MabCure's president, CEO, and co-founder, "...if you're looking to screen ... a very large population, you need to be able to [make] very large libraries of antibodies."
The article went on to discuss MabCure's scientific strategy to create antibodies against new and unknown cancer markers. "Rather than develop antibodies against defined and well-known antigens, the company took the opposite approach: They generated and found antibodies against specific antigens without knowing a priori what they were."
The article quoted Dr. Gonenne as saying, "...the company plans to extend the clinical trial to include centers in Europe for potential approval of a diagnostic in that market. Then, it would file with the FDA to market such a test in the US."
Dr. Gonenne commented on the GenomeWeb coverage, "we are delighted to receive coverage of this caliber from a news organization as esteemed as GenomeWeb. Media coverage such as this affords us the opportunity to share our science with the rest of the scientific community and the public-at-large."
SOURCE: MabCure, Inc.
MabCure
Dr. Amnon Gonenne
President and CEO
amnon.gonenne@mabcure.com
or
Investor Relations
Jim Fallon, 212-732-4300
jfallon@ceocast.com
Thanks McMac. Your reply helps me a lot in understanding these 2 companies.
I just invested in ARYC for the first time this week because this company sounds so promising in its quest to diagnose Ovarian cancer in the early stages when it is highly treatable. There is another company, Mabcure (MBCI), that I also invest in. They also announced on 1/6/10 in press release "MabCure Launches Clinical Trial to Diagnose Ovarian Cancer" they use a different technology i.e highly specific monoclonal antibodies MAbs. MBCI also plans to expand the research to colon, breast and prostate cancers. It appears that ARYC is in late stage developemnt of the Ovarian tests, where MBCI is in the early stage of the development process. I'm just curious if ARYC and MBCI both are successful in their trials whether they both can thrive in the testing market world.