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HUGE NEWS!!! StatSure Receives CLIA Waiver!!!
StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA
Monday November 5, 8:30 am ET
FRAMINGHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR.OB - News) announced today that the U.S. Food and Drug Administration ("FDA"), through its Center for Devices and Radiological Health, has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 ("CLIA") for an HIV 1/2 Rapid Test employing the Company's patented "barrel" technology. The HIV 1/2 product is marketed and distributed worldwide by Inverness Medical Innovations (Amex: IMA - News) under its Clearview® brand as "Clearview COMPLETE HIV 1/2."
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Specifically, the test has been waived for use in detecting HIV-1 and HIV-2 antibodies in human whole blood, serum, and plasma and demonstrates a sensitivity of 99.7% and a specificity of 99.9% in clinical trials. With this waiver, the CLEARVIEW ® HIV-1/2 test can be used by more than 189,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices. StatSure's patented "barrel" technology is designed to maximize safety, convenience, performance and shelf-life and minimize exposure to infectious agents.
Steve Peltzman, CEO of StatSure, stated: "We are very excited about this achievement and the underlying markets that now may commercially be pursued." StatSure hopes to leverage this proprietary "barrel" format to develop and commercialize additional point-of-care rapid screening tests for other infectious disease.
ABOUT STATSURE
StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company has developed and is marketing a product line of patented, oral- fluid collection devices. The Company's proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of the company's diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. Certain of these products are sold in the United States as well as internationally to various distributors for use in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations. Inverness Medical Innovations, Inc. (Amex: IMA - News), StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) and Chembio Diagnostics, Inc. announced in October of 2006 agreements that provide Inverness with exclusive worldwide marketing rights to Chembio's FDA-cleared, point of care, rapid test for the detection of antibodies to HIV. The test utilizes Inverness' proprietary lateral flow technology as well as StatSure's patented "barrel" technology designed to maximize ease of use and minimize exposure to infectious agents.
Please visit our website at http://www.StatSure.com
FORWARD-LOOKING STATEMENTS This press release may contain forward-looking statements within the meaning of the federal securities laws. These statements reflect StatSure's current views with respect to future events and are based on management's current assumptions and information currently available. Actual results may differ materially due to numerous factors, including without limitation, the future demand for HIV testing products; our ability to successfully commercialize the products; the intensely competitive environment in the relevant markets and the risks and uncertainties described in periodic reports filed by StatSure with the Securities and Exchange Commission under the federal securities laws, including periodic reports on Form 10-Q or Form 10-QSB, as applicable, for the period ended June 30, 2007. StatSure undertakes no obligation to update any forward-looking statements contained herein.
I came across an internet video bit the other day with Cramer and a cohort discussing pharma stocks and vaccines and related matters and they were big on Merck and IMA. IMA for testing stuff and as we know SSUR has a deal with IMA.Good prospects all and Cramer and friend agree.
SSUR Q report due within the next 2 weeks. It will be interesting to see how the accountants post the $500K from Inverness.
Ranking: “BUY”
Price at 10.25.07: $0.40
Valuation: $1.25
52 Week Range: $0.12 - $1.03
Market Capitalization: $15.27 m
Float: 23.27 m
Shares Outstanding: 38.18 m
Shares Fully Diluted: 46.20 m
Fiscal Year End: Dec
Exchange: NASDAQ (OTC: BB)
Scimitar Equity Research
http://www.scimitarequity.com/research/SSUR.OB.2007_Review.pdf
StatSure Diagnostic Systems, Inc. Review Issued By Scimitar Equity Research, Inc.
Last Update: 8:00 AM ET Oct 26, 2007
BOSTON, Oct 26, 2007 /PRNewswire via COMTEX/ -- Scimitar Equity Research, Inc. (Scimitar) issues a review of StatSure Diagnostic Systems, Inc. entitled, "Opportunity Unfolds for Investors Seeking to Participate In a Proprietary Point-of-Care Firm".
This review is available at our website: http://www.scimitarequity.com.
http://www.marketwatch.com/news/story/story.aspx?guid=%7B357C72AB-4D9B-4B70-858D-272B74200C20%7D&siteid=nbs&symb=
Last week before it jumped, I had a bid in for 5K on one account and 10K on the other. Those pesky MMs filled 4 shares for one and 8 shares of the other. It means I have to stay in until at least $2 just to break even on the trades. So, I guess I'm in for the long term, too. LOL But, what really burned my bacon was that they didn't post either fill so I didn't event get to see the trades lift the price from 20 cents. I almost went postal.
Ha d to go back to Hanoi for a week to lecture again and just got back... I got in for a long term play... If I can pick up more on these dips I do, but have not been able to fill anything for over a month...
To my loyal base. Sideways movement in a consolidating pattern and reduced volume. (LOL) Should sit here for a day or two before resuming the climb as we near financials and???
This is like watching paint dry, or grandpa fall asleep in the lounge, or... or... or guarding the food court, after hours. Yaaawn.
Hello!!! Hello!... hello!... hello....
Still an echo here. Anyone home?
Now that's interesting. 6K shares took the closing price from .30 to .40, and those 6K shares completely wiped out .35 which is now the bid. This will make $1 easily by Christmas with any meatie PR and a solid Q for mid-November.
Will we have another 1 cent per share profit for the quarter?
Dare I say? Suddenly the chart is looking (low volume) bullish.
Don't look now, but
SSUR is trading with a quasi-normal spread and activity. Actually have a volume of 12,700 with a spread of only 5 cents, .30/.35, with trades in between. Something has changed? Must be some Euro-contracts coming in. No, that would have stimulated even higher volume, or would it? Hmmmm.
Wow! Two days after the big PR and we finally get a little trading. Very little trading. 2400 shares for the day takes out .34 and now at .35 with a bid up .02 to .22. Well, looking at the spread, at least the bottom now shows I'm entirely green for my holdings of SSUR. Until the MMs decide to take out the bid again and return to the teens, anyway. Sure was difficult to acquire and accumulate here.
So, to the vaccum I call a chat board, have a great weekend.
What wierdness. I've never seen a PR met with absolutely no buying or selling. My .25 bid for 5K shares never posted. How can the MM bastages get away with not posting the best bid? What possible criteria could they use that would allow them to not post bids between .20 and .34?
Could be - IMA is the best and only associates with the best.
Just for yayas, 3 hours ago I placed an order for 5K shares @ .25 and the MM bastages still haven't posted it. 20 cents is not the best bid. These guys are hiding better bids to prevent trading. Bastages!!
Inverness says the current market value, discounted, should be .35. There are shares available at .34, yet the "best bid" posted by MMs is still .20. Does any of this make sense to anyone, or am I the only one shaking my head over the consistently wide spread?
Also, Inverness is betting that .75 will be a bargain in the future
The strategic investment consists of a purchase of 1,428,572 common shares at a price of 35 cents per share. Additionally, Inverness received 5 year warrants to purchase up to an additional 1.1 million shares of the Company's stock at a price of 75 cents per share. The proceeds of this investment will be used for general corporate purposes and to fund development of other infectious disease applications for the Company's patented test format.
So, this is not just good news to day, potentially it is VERY good news for us?!!!
I get the feeling that if IMA likes a company's products they buy the company!
Ref - from Yahoo:
StatSure Signs Strategic Financing and License Deals with Inverness Medical Innovations
PR Newswire (Wed 8:30am)
• Inverness Medical to buy Australia's Panbio for $37 mln
at Reuters (Mon, Oct 8)
• Inverness Medical Innovations Agrees to Acquire Panbio Ltd.
PR Newswire (Mon, Oct 8)
• Inverness buys UK firm
bizjournals.com (Thu, Oct 4)
• Wednesday's Health Winners & Losers
at TheStreet.com (Wed, Oct 3)
• Inverness Medical acquires Bio-Stat Healthcare for $33.4 mln
at Reuters (Wed, Oct 3)
• Inverness Medical Innovations Acquires Bio-Stat Healthcare Group
StatSure Signs Strategic Financing and License Deals with Inverness Medical Innovations
Wednesday October 17, 8:30 am ET
FRAMINGHAM, Mass., Oct. 17 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) today reported receipt of a $500,000 strategic investment from Inverness Medical Innovations, Inc. (Amex: IMA - News). In connection with this financing, StatSure and Inverness signed two additional agreements. First, the two companies signed an agreement whereby Inverness acquired an option to the exclusive, worldwide marketing and distribution rights to certain infectious disease diagnostic tests developed by StatSure that may utilize specified Inverness and/or StatSure intellectual property. If exercised by Inverness, the option provides for StatSure and Inverness to equally share development expenses and profits. StatSure and Inverness also entered into a license agreement whereby Inverness granted to StatSure a license to certain Inverness lateral flow patents for use in a rapid test to detect HIV antibodies in point-of-care markets subject to payment of royalties to Inverness. This license pertains to HIV tests using formats other than the StatSure's "barrel format" which is already being sold by Inverness and awaiting a CLIA Waiver from the FDA.
The strategic investment consists of a purchase of 1,428,572 common shares at a price of 35 cents per share. Additionally, Inverness received 5 year warrants to purchase up to an additional 1.1 million shares of the Company's stock at a price of 75 cents per share. The proceeds of this investment will be used for general corporate purposes and to fund development of other infectious disease applications for the Company's patented test format.
Steve Peltzman, StatSure's CEO and Chairman, stated: "We are delighted with the opportunity to broaden and strengthen our strategic relationship with Inverness and hope to take full advantage of these opportunities to build revenues, market share and profits."
SSUR believes it is now poised to become a key participant in the point- of-care market for infectious disease tests. The Company believes it has the simplest, safest and most reliable product platform that meets the needs of the public health clinics, doctors offices, military, insurance industry, hospitals, and potential OTC markets.
ABOUT STATSURE
StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company has developed and is marketing a product line of patented, oral- fluid collection devices. The Company's proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of the company's diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. Certain of these products are sold in the United States as well as internationally to various distributors for use in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations. Please visit our website at http://www.StatSure.com
Source: StatSure Diagnostic Systems, Inc.
Friday demonstrated just how few shares are available at the current price. Bid/ask locked at .30/.51, which is significantly changed from Thursday, and could easily change again before open on Monday.
Still, the 3 buys on Friday totaled 15,400 for the day, which is a significant change from the more than 2 weeks without a trade .30. It could easily be buying in anticipation of a 3rd consecutive quarter of profitable earnings, or it could be any number of other reasons, including my non-stop pumping of this stock on this forum.
Interesting, the bid just came up for the first time in 2 weeks. Something afoot? Hmmm.
Not a single trade since a week ago Monday. I can't say that I've ever been into a stock quite like this one. No buying because no leaking of info, no insider trading, and no selling for the same reasons. I wonder if the SP will begin to move soon? We should know when those Euro orders for field detectors are finally reported.
I always wonder why they do trades at .15 when there are bids out there at higher levels... MMs up to no good...
I've had an order in at .20 for the last 3 days and it has yet to post. So, I agree, the current price is no indication of market value. We do need some news soon, and I hope we don't have to wait for the next Q report in 4 to 6 weeks.
I have orders in @ .15 that dont get filled so we are not really at that low pps in my opinion...
I wish SSUR were speaking at the seminar with Dr S... need to see some movement here...
Hi DrFeelgood
Great name you have, guess you must have a lot of happy patients LOL. Anyways I have done some more DD on SSUR, when I posted my previous message I had only done some light DD late a night and just wanted to know if anyone knew of anything in particular that I should pay attention to.
Firstly I was a bit fast on the trigger as I thought SSUR had already received the CLIA waiver, don’t ask me how I misunderstood that (late evening I guess) but anyway they haven’t received it yet and that is obviously one of the things that the marked is waiting for.
Besides that here is what I found.
When I first looked at SSUR, I thought what a great product, HIV test in 15 min, I could see that there could be a huge marked for a product like that, especially if they could get to a point where they could sell over the counter like for example a pregnancy test, but SSUR is not the only company thinking that, this is according to SSUR themselves a very competitive marked.
This is from SSUR’s SEC filing
Orasure Technologies, Inc. is also a major competitor to our rapid HIV barrel technology in the U.S. Orasure Technologies, Inc. has an FDA approved blood-based and oral fluid-based rapid HIV test. Several companies market or have announced plans to market blood-based or oral fluid-based HIV rapid tests in the United States and abroad. MedMira and Trinity Biotech have also received FDA approval to sell rapid HIV blood tests in the United States. We believe other companies may seek FDA approval to sell competing rapid HIV tests in the future.
I had a look at Orasure which have a product similar to SSUR, it also gives a result in 15 min, and seems like it is also very easy to use, now Orasure has already received their CLIA waiver back in 2004 and has a very strong balance sheet with over 100 mil in cash and revenues of over 80 mil a year.
What I am trying to say is where is SSUR’s advantage, where is their competitive edge, if there is already a lot of companies out there making similar products then the only thing SSUR can compete on is price, which in the long run will erode profit margins, and if they are going to compete on price then Orasure is going to be a very strong competitor with a product that has already been on the marked for years and a lot stronger financial position.
Then there is the very low PE which SSUR have, but that has only been achieved through a non cash gain, here is from the SEC filings again.
Derivative income (expense): Derivative income of $644,435 was recorded in the second quarter of 2007 from a derivative expense of $(2,346,192) recorded in the second quarter of 2006, and derivative income of $2,040,696 was recorded in the first six months of 2007 from a derivative expense of $(2,346,192) in the first six months of 2006. The fluctuation was due to the mark-to market adjustment on embedded derivatives principally driven by the decrease in our common stock price $0.55 to $0.249.
I am not sure exactly what this is but looks like they have booked a non cash gain of $2,040,696 through some kind of hedging of their own share price, which means without this gain they would have posted a loss of around $0.03 per share, now I am not saying that this is bad, just that the profitability was not achieved through the sales of the company’s products but merely from this non cash gain.
They have however had increased GA cost due to the restating of quarterly filings back to 2005, and they might turn a profit in the quarters to come from sales alone if the GA costs are going to fall in the future.
With the information stated above I have decided not to take a position at this point in time, if I am going to invest in companies in the medical industry, then I would like them to have a competitive advantage so as to create some kind of monopoly, and at the moment I can’t see that SSUR has that. That is not to say that SSUR is not a good buy a these very cheap prices, but I am going to wait until they start making some more profit before I invest in them.
Besides that I have seen you on the NNVC board were you always post very good information, thanks for that. I am keeping an eye on that as well as I find that to be a very interesting company, and I will most likely take a position there at some time in the future.
Best of luck with your investments.
Regards
A.H
Did you find anything? I'm still looking for negatives. In the Q end March 31 filing they mentioned a need for money and the market seemed to think that meant dilution. My guess is that someone is short on this stock and the artificial huge spread is the result. Whence, very, very thin trading and a severely depressed price. JMHO
Hi guys
Just stumbled across this stock while surfing Ihub, looks almost to good to be true, a profitable company with the lowest PE I have ever seen, what seems to be a very good product, low OS, huge insider ownership, agreement already in place with 2 big companies and a recently received waiver which opens up the marked for up to 189000 outlets.
So what gives, why is the company trading at such a low price, is this just because we are on the OTC or is there something else to be aware of?
I have read through all the messages posted (thanks everybody for all the excellent info) but haven’t found anything worrying so far, not in the sec fillings either.
I will continue my DD, and if I can’t find anything worrying over the weekend, then I will probably take a small position next week.
Besides that, does anyone happen to know the sales and manufacturing cost of these test devises, i.e. profit margin, I can see in the filing that they will share the profit equally after manufacturing costs are covered, but would like to know any prices if anyone knows.
Have a nice weekend
TIA
A.H
All numbers are in thousands, of course. EOM
Net Income Applicable To Common Shares $228 $871 $2,321 $941
http://finance.yahoo.com/q/is?s=ssur.ob
Sure looks to me like SSUR will turn in a 3rd consecutive quarter of profits. They already have 3 cents a share for the first 2 quarters of the corporate year.
I'm curious about the statement, "...StatSure has been receiving initial purchase orders from twelve countries throughout Europe." If they are the chosen field testing medium for DUIs, then that could be some rather significant orders.
I also like the >80% recovery, with the highest rate of all tested for THC. I'm sure that was a major factor in the selection of StatSure by DRUID and those 12 countires. The results for Plastic Tube are interesting. I wonder what a 102% recovery is? Did they recover more than the original original sample?
Table 1. Results of the recovery experiments.
============================================
Device........Δ9-THC.......Other analytes
------------------------------------------
Greiner......73.60%........ 86.4%-98.5%
Intercept.... 37.60%....... 88.9%-116%
Quantisal.... 55.80%....... 81.1%-111%
SalivaSampler 85.40%....... 81.3%-91.1%
Cozart....... 75.90%....... 66.0%-91.6%
Salivette.... <10%......... 15.9%-51.8%
OraCol....... <10%......... <10%-69.8%
Salicule..... 45.90%....... 92.2%-99.6%
OraTube...... 47.50%....... 39.8%-86.7%
Plastic Tube. 74.60%....... 93.6%-102%
The Saliva•Sampler™
Oral fluid collection devices
The Saliva•Sampler™ Saliva Collection Device
Saliva•Sampler™ is the only collection device available that offers a built-in Sample Volume Indicator, that creates a blue mark when sufficient sample has been obtained. The unique design of this product also eliminates a potentially time-consuming , manual step-- centrifugation-- and offers a quick, convenient, dignified, and painless alternative for gathering oral fluids.
(US Patent# 5,376,337)[http://tinyurl.com/35gznd Inventor: Seymour; Eugene H.]
SALIVA TESTING
Numerous studies have shown that saliva as a drug test specimen represents a viable alternative for drug testing programs. Additionally, the use of saliva rather than urine makes it possible to address a number of burdensome issues that have plagued drug testing for many years. For example, saliva is, by far, a much less invasive specimen for collection purposes. Few people find it offensive to provide a saliva sample versus urine. Saliva also makes it possible to conduct an observed collection every time while urine would requires an observed donation to obtain the same assurance of sample integrity.
Interest in the use of saliva for drug testing purposes is growing rapidly and the guideline should not only reflect this, but also be careful not to inadvertently restrict or discourage its use. This is especially true at a time when adulteration and substitution problems associated with urine testing are beginning to impact the integrity of the drug testing process overall, and the provision of a specimen that can be observed every time significantly reduces the opportunity for substitution and adulteration.
Because saliva has a narrow window of detection time, depending on the drug, dosage level, sensitivity of the detection method, and the donor’s metabolic rate, saliva makes an excellent indicator of “under the influence” status, particularly effective as an accurate post-accident, reasonable suspicion test, or a fit-for-duty test. Additionally, all urine and saliva-based drug tests are “recent use” tests and as such have the capability to be used for pre-employment, random, and return-to-duty testing; in fact, with some drugs (e.g., cocaine, amphetamines and THC), depending on dose level and assay sensitivity, the window of detection for saliva will overlap that of urine (Cone, Edward J. in Malamud, D. and Tabak, L. (eds) Saliva as a Diagnostic Fluid. “Saliva Testing for Drugs of Abuse”, Annals N.Y. Academy, Sci., vol. 694 (1993), pp. 91-127).
Saliva has already been validated and approved in many states as a viable specimen for use in the criminal justice system, for all drugs, including THC (without any passive inhalation issues). Additionally, several participants in the European Union-funded ROSITA project have published the results of their studies and have defined the “perfect on-site drug test” as a saliva-based, instrumented (for objectivity and elimination of user interpretation), panel test, with results in 5 minutes.
http://www.statsurediagnostics.com/index.php?id=15,0,0,1,0,0
"Statsure collector gave best results for recovery (>80%
for all substances) and for stability, was quick to use
(<2min collection time) and got good user comments
Statsure was chosen for the OF collection
device of the DRUID project"
Concluding remarks, DRUID report
National Public Health Institute, Finland
http://statsure.com/TIAFT_OF_collection_devices.pdf
StatSure Saliva Sampler(TM) Chosen From Nine Different Collectors
Last Update: 8:30 AM ET Aug 28, 2007
FRAMINGHAM, Mass., Aug 28, 2007 /PRNewswire-FirstCall via COMTEX/ -- StatSure Diagnostic Systems, Inc. is pleased to announce that the results of the studies done at the National Public Health Institute of Finland, (Helsinki, Finland) whereby StatSure's Saliva Sampler(TM) was chosen as the standard for sampling oral fluid / saliva in all tasks in DRUID (EU funded research project Driving Under Influence of Drugs, alcohol and medicines), are being presented at TIAFT Conference (The International Association of Forensic Toxicologists) in Seattle this week.
The aim of the study was to investigate the best oral fluid collection device that is:
The investigated devices were Greiner Bio-One, Orasure Intercept(R), Immunalysis Quantisal(TM), StatSure Saliva Sampler(TM), Cozart(R), SarstedtSalivette(R), Malvern Medical OraCol, Acro Biotech Salicule, Varian OraTube(TM).
The overall recovery of the analytes, after the whole sampling process, is of primary importance when selecting an oral fluid collection device for toxicological analysis. Considerable differences in the overall reliability of oral fluid collection devices were noted. The results of the study emphasize the impact of the selection of the oral fluid collection device on the whole toxicological procedure. StatSure's Saliva Sampler(TM) gave best results for recovery (>80% for all substances), for stability, was quick to use(<2min collection time), and got good user comments.
As a result of being chosen by DRUID, StatSure has been receiving initial purchase orders from twelve countries throughout Europe.
For a copy of the complete report, please visit the following link on our website: http://statsure.com/TIAFT_OF_collection_devices.pdf
About StatSure:
StatSure Diagnostic Systems, Inc. is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company has developed and is marketing a product line of patented, oral- fluid collection devices. The Company's proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of the company's diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. Certain of these products are sold in the United States as well as internationally to various distributors for use in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations.
SOURCE StatSure Diagnostic Systems, Inc.
http://www.statsure.com Copyright (C) 2007 PR Newswire. All rights reserved End of Story
Wow, does this ever trade thin. 7700 shares have moved today, the first trades in a week, and the ask moves to .30. Looks like there is very little available at 30 cents, too.
If you folks want to load up on SSUR, the only way is to hit the ask. I know everyone is used to MMs lowering the price to the buyers, but I've been watching this for a while and for 3 months nearly the only orders filled have been at the ask. I loaded between .17 and .23 by doing that. I couldn't get fills any other way, and sure enough, my little bit of buying, along with one or two others, has lifted the price.
I'm waiting to clear some more funds so I can get some more under .30.
Seriously - if they could come up with a test that indicates one has that obesity virus - whatta boon to mankind - then just take the NNVC obesity virus killing viricide and voila - no more fatty me!! At least not because of the OV (Obesity Virus).
I certainly hope so, because I'd sure like to know what virus is causing me to have to work out every day just to stay minimally obese.
maybe they can get in on that obesity disease thing as well.. ;)
I find this especially interesting:
"According to Steve Peltzman CEO of StatSure: "Having this product CLIA waived should begin to capture the commercial potential of this product and allow SDS to go forward with its plan to expand the use of this format to other infectious diseases and to establish new strategic partnerships."
CLIA Waiver Submitted for Rapid HIV Test Employs StatSure's 'Barrel' Technology
Tuesday August 14, 8:30 am ET
FRAMINGHAM, Mass., Aug. 14 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is pleased to announce that its patented, "barrel- test" format for the detection of antibodies to HIV-1/2 in human whole blood, serum, and plasma has completed the trials needed for a CLIA waiver application and that the results have been submitted to the United States Food & Drug Administration (FDA) for their review. The Company believes the results of these trials were consistent or superior to those of other rapid point of care products that have received a CLIA waiver. The HIV 1/2 product is marketed and distributed worldwide by Inverness Medical Innovations (Amex: IMA - News) under its Clearview® brand as "Clearview COMPLETE HIV 1/2". If CLIA waiver were granted for this product, it would greatly expand the available market for this product in the U.S. There are approximately 189,000 testing sites across the United States, including doctors' offices and clinics that require a test to be CLIA waived before it can be used. The United States Centers for Disease Control recommends HIV testing as part of the routine medical care of most Americans. On May 25, 2006, this HIV 1/2 test received marketing approval from the United States Food and Drug Administration's (FDA) Center for Biologics and Research (CBER) -- a prerequisite to submitting the CLIA Waiver Application.
According to Steve Peltzman CEO of StatSure: "Having this product CLIA waived should begin to capture the commercial potential of this product and allow SDS to go forward with its plan to expand the use of this format to other infectious diseases and to establish new strategic partnerships."
About StatSure:
StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company has developed and is marketing a product line of patented, oral- fluid collection devices. The Company's proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of the company's diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. Certain of these products are sold in the United States as well as internationally to various distributors for use in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations.
Forward-Looking Statements
Statements contained herein that are not historical facts are forward- looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties.
Source: StatSure Diagnostic Systems, Inc.
Chembio Submits CLIA Waiver Data for HIV Barrel Test to FDA
Waiver Would Greatly Expand U.S. Market Potential of FDA-Approved Test
Last Update: 8:32 AM ET Aug 14, 2007
MEDFORD, NY, Aug 14, 2007 (MARKET WIRE via COMTEX) -- Chembio Diagnostics, Inc. has completed the studies required as part of a Clinical Laboratory Improvement Amendment (CLIA) waiver application for its "HIV barrel format" rapid test. Chembio has submitted this data and associated information in an amendment to its 2006 submission to the Center for Devices and Radiological Health division of the United States Food & Drug Administration (FDA). If the CLIA waiver is granted, it would expand the available market for Chembio's HIV barrel format test to include doctors' offices and clinics, as well as other hospitals and reference laboratories. This unique, self-contained rapid HIV test is FDA approved and exclusively marketed worldwide by Inverness Medical Innovations, Inc. as Clearview(R) COMPLETE HIV 1/2.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established that some tests could be waived from certain laboratory requirements. Waived products include tests that employ methodologies that are so simple to use as to render the likelihood of erroneous results negligible; or that pose no reasonable risk of harm to the patient if the test is performed incorrectly. Rapid HIV antibody tests were only added to the list of tests that could be waived within the last few years, and this development is what created the main U.S. market opportunity for these products.
A CLIA waiver greatly expands the available potential U.S. market opportunity for a product from sites that require much greater certification and oversight (i.e. reference laboratories and hospitals) to additional venues where point of care testing is particularly beneficial (i.e. emergency rooms, doctors offices and public health clinics). There are approximately 189,000 testing sites across the United States that can use tests that are CLIA-waived. The United States Centers for Disease Control has issued recommendations that HIV testing become part of the routine medical care provided to all Americans between the ages of 13 and 64. Chembio's HIV barrel product was approved in 2006 by the FDA, initially as a moderately complex product. This approval was a prerequisite to submitting the CLIA Waiver Application.
According to Larry Siebert, CEO of Chembio, "Obtaining a CLIA-waiver for our HIV barrel test, combined with our HIV STAT PAK(R) cassette product which is already CLIA-waived, should significantly enhance the point-of-care rapid HIV product offering of our US marketing partner."
ABOUT CHEMBIO
Chembio Diagnostics, Inc., a developer and manufacturer of rapid diagnostic tests for infectious diseases, is on the frontlines of the global battle against the AIDS pandemic. The Company has received marketing approval from the FDA for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid tests, marketed under the brand name Clearview(R) in the United States by Inverness Medical Innovations. The Company also manufactures rapid tests for veterinary Tuberculosis and Chagas Disease. In March 2007 Chembio was issued a United States patent for the Dual Path Platform (DPP(TM)), a next generation lateral flow platform. DPP has demonstrated significant advantages over currently available lateral flow methods, including increased sensitivity, sample flexibility, and multiplexing capabilities.
Further information please visit http://www.chembio.com
Contacts: Company Contact: Chembio Diagnostics, Inc. Matty Arce 631-924-1135 ext 123 www.chembio.com Investor Relations Contacts: Lippert/Heilshorn & Associates, Inc. Anne Marie Fields (afields@lhai.com) (212) 838-3777 Bruce Voss (bvoss@lhai.com) (310) 691-7100 http://www.lhai.com
SOURCE: Chembio Diagnostics, Inc.
http://www.marketwatch.com/news/story/story.aspx?guid=%7B5F86030A-24DE-42A3-8D43-9C957EBE5743%7D&...
10Q is out!!! Back to back profitable quarters!!!
http://www.sec.gov/Archives/edgar/data/885534/000114420407042227/v084069_10qsb.htm
Against the background of a very red market, SSUR had no sales, again. Yes, there was no selling, no buying either, sure, but no selling. Lets hope we continue the trend until the financials are released.
Good news/Bad news (GN/BN)
GN: No selling today as the lowest offered shares were at 30 cents all day. Only 5K share buy yesterday took out everything from .22 to.30.
BN: No buying since no one seems interested in paying more than .19 until the next Q report or PR, whichever comes first.
GN: MMs seem reluctant to make a market here since that would require induced buying and they probably don't want to get caught with open positions below .25 or .22 or .19 or whatever.
BN: The total lack of any dynamics whatsoever for 2 months has no doubt taken SSUR off the watch list of any TA investor.
GN: When the SP begins to move (And it has edged up from .17 to .22 over the past month) it could be days before it registers on anyone's radar, unless it triggers a price alert. So, the momo players will be slow to arrive.
BN: Looks like a lot of players will be slow to arrive for the same reasons.
GN: Once buying arrives on news that narrows the spread and takes the SP up to levels of higher volume, a reversal will confirm and a rise to above $1 is likely.
Score:
GN - 4
BN - 3
Wow, some volume today and a couple of trades. Must have been someone jumping over to HMPG. A little profit from the teens (I would hope) and an impatient jump to the big mover just before this one starts to move up. Such is life in the OTC/NASD.
I take it as a good sign. How rare is it for a BB listed stock not to trade for days as MMs are always overwhelmed by the need to make a market and feel compelled to fill orders by taking the price down? Don't see that here. Just waiting for the Q report due out soon (or later).
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