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Chembio Receives FDA Approval for Its Rapid HIV Tests Tuesday May 30, 7:55 am ET Company Expects New Market Opportunities and Revenue Growth
MEDFORD, N.Y.--(BUSINESS WIRE)--May 30, 2006--Chembio Diagnostics, Inc. (OTCBB:CEMI - News) has received approval from the U.S. Food and Drug Administration (FDA) for its SURE CHECK® HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid test Pre-Market Applications (PMAs). The approved PMAs allow Chembio to market its rapid HIV tests to clinical laboratories and hospitals in the United States. FDA approval also allows Chembio to further expand its international marketing efforts into countries that require regulatory approval in the manufacturer's country of domicile.
Lawrence Siebert, President and CEO of Chembio commented, "On behalf of all of our shareholders, I would like to congratulate our dedicated employees who have worked so hard for this achievement, one that has been accomplished with remarkable efficiency because of their hard work and commitment. FDA approval opens up the very important U.S. market to Chembio, one that should produce significant revenues. This importance has increased in view of the recommendations that are reportedly forthcoming from the United States Centers for Disease Control that HIV tests become a part of routine medical care for most Americans. Rapid HIV tests are essential tools for HIV prevention and treatment campaigns in the United States and globally, and these campaigns are scaling up. Chembio remains committed to being a global provider of competitively priced rapid HIV tests in order to help address this global epidemic. We expect that our rapid HIV tests will be sold in the U.S. market at higher average selling prices than our current sales to the developing world given our investment and ongoing costs related to U.S. approval, marketing and distribution."
SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid tests are easy to perform. They are highly sensitive (99.7% for HIV-1 and 100% for HIV-2) and specific (99.9%). The tests have a rapid turnaround time of approximately 15 minutes. They are safe to use, requiring a very small sample of whole blood (as little as 2.5-5.0 micro-liters which is approximately 1/10 of a drop of blood), easily obtained with a finger prick. Chembio's FDA PMA approval is for use not only with finger-stick whole blood samples but also with venous whole blood, serum and plasma samples. Both products have a built-in internal control (a true IgG), which gives confirmation of sample addition as well as valid test performance.
Chembio's tests uniquely offer a 24-month shelf life from date of manufacture at 46-86 degrees Fahrenheit, a significant advantage over other products currently on the market. This advantage may become more important if rapid HIV tests such as Chembio's are approved for the over the counter markets in accordance with guidelines that the FDA's Blood Products Advisory Committee (BPAC) recently recommended.
Chembio believes that the U.S. rapid HIV test professional market will exceed $50 million within the next couple of years. The U.S. market opportunity has been developing first in the public health and hospital emergency room segments. As a result of increased advocacy for routine testing as has been widely reported recently, this market will likely increase to include use of this technology in physician's offices, prisons, and other venues.
In the State of the Union Address this year, President Bush proposed more than $90 million for the purchase and distribution of rapid HIV tests for the testing of more than 3 million additional Americans. Worldwide, based upon an analysis done by the Global Business Coalition of HIV/AIDS (www.businessfightsaids.org), hundreds of millions of people will need to be tested over the next several years in order to insure that funded treatment targets are achieved.
The Company intends to file, during this current quarter, an application to the FDA for a waiver under the Clinical Laboratory Improvement Act (CLIA) of 1988. The CLIA waiver would expand the usage settings of the tests to beyond laboratories and hospitals to public health clinics, physicians' offices, and other venues. The Company has completed the studies required in order to submit the CLIA waiver application. The Company believes there are only two other rapid HIV tests that are PMA approved products and that are also CLIA waived. Chembio believes that its tests will meet the CLIA waiver requirements.
Chembio is currently in discussions with a U.S. marketing partner that it anticipates will exclusively market these products in the U.S. These discussions are continuing, though there is no assurance that these discussions will result in a definitive agreement.
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The first quarter 2006 financial results are also impressive, check it out:
Chembio Reports First Quarter 2006 Financial Results Monday May 15, 12:10 pm ET Net Product Sales Increase 238% Compared to the First Quarter of 2005
MEDFORD, N.Y.--(BUSINESS WIRE)--May 15, 2006--Chembio Diagnostics, Inc. (OTCBB: CEMI - News) reported first quarter 2006 financial results. Revenues for the first quarter of 2006 were $1.24 million, a 69% increase compared to first quarter 2005 revenues of $732,000. Net product sales for the first quarter increased 238% to $1.17 million compared to $346,000 for the first quarter of 2005. The first quarter 2006 net loss attributable to common stockholders was $1.94 million or $0.22 per share compared to a net loss attributable to common stockholders of $3.5 million or $0.50 per share for the first quarter of 2005.
The first quarter revenue growth was attributable to increased sales of the Company's rapid HIV tests. Rapid HIV test revenue for the first quarter of 2006 increased approximately 496% to $537,000 as compared to $90,000 in the first quarter of 2005. The Company also received its first significant order for its Chagas STAT-PAK(TM) rapid test, in the amount of $1.2 million, of which it shipped $480,000 in the first quarter of 2006 and expects to ship the balance in the second and third quarters of 2006.
Financial Outlook
The Company believes that sales of its HIV products will continue to increase in 2006 as a result of both the international marketing strategies that were implemented in 2005 and sales to the United States market after anticipated approval from the U.S. Food and Drug Administration (FDA). The Company also expects to generate additional revenues in 2006 from its Chagas STAT-PAK(TM) rapid test. Furthermore, with the commercial release in late 2006 of the PrimaTB STAT-PAK(TM) rapid test, the Company expects to begin generating revenues from that product in early 2007.
Recent Highlights:
*Received an "approvable" letter from the FDA for its SURE CHECK® HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid test Pre-Market Applications (PMAs). The FDA letter states that Chembio's PMA approval is subject only to final review by the FDA of the package inserts for each of the products, and other standard conditions related to all PMAs. The Company therefore anticipates that the PMA will be approved in the very near future. Chembio is in discussions with a marketing partner for distribution of the products in the U.S.
*Developed a Dual Path Platform technology for rapid diagnostic tests that offers significant advantages over the lateral flow technology used in commercially available rapid diagnostic tests. Chembio expects to develop new tests using the technology as well as license the technology to other companies for use in their tests.
*The Nigerian Ministry of Health designated Chembio's HIV 1/2 STAT-PAK(TM) as a screening test in four out of the eight testing protocols that comprise Nigeria's Interim National Testing Algorithm.
*Chembio's rapid HIV tests were evaluated and recommended for use in Kenya. The tests were evaluated by the National AIDS/STD Control Programme of the Kenyan Ministry of Health and met their sensitivity and specificity requirements.
*The FDA's Blood Products Advisory Committee proposed regulatory requirements for the approval of over the counter distribution of rapid HIV tests.
*The U.S. Centers for Disease Control and Prevention plans to issue revised HIV testing guidelines, which recommend that doctors begin voluntary HIV testing as a part of routine medical care, for everyone in the United States between the ages of 13 to 64.
"Chembio Diagnostics is very well positioned in all of its markets," said Lawrence Siebert, President and CEO. "The international market is growing rapidly as funded HIV treatment programs strive to reach treatment goals. Internationally, there is an expected overall demand for several hundred million rapid HIV tests over the next few years. The U.S. market is also growing rapidly and is expected to expand even further in the coming years boosted by CDC's recommendation for routine HIV testing and the progress being made towards approval of over the counter sales of rapid HIV tests."
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Due to the relatively low volume today following the FDA approval announcement this morning, I believe this stock (CEMI) is an undiscovered gold mine. Load up!
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Emerging Stock Report: Faster Testing = Better Health
M2 Communications via COMTEX
May 30, 2006 1:38:31 PM
May 30, 2006 (M2 PRESSWIRE via COMTEX News Network) --
It is believed that the U.S. rapid HIV test professional market will exceed $50 million within the next couple of years. The U.S. market opportunity has been developing first in the public health and hospital emergency room segments. As a result of increased advocacy for routine testing as has been widely reported recently, this market will likely increase to include use of this technology in physician's offices, prisons, and other venues. President Bush proposed more than $90 million for the purchase and distribution of rapid HIV tests for the testing of more than 3 million Americans. Worldwide, hundreds of millions of people will need to be tested over the next several years in order to insure that funded treatment targets are achieved.
The Emerging Stock Report is initiating coverage on Chembio Diagnostics, Inc. (OTCBB:CEMI). Chembio Diagnostics, Inc. possesses expertise in the development and manufacture of rapid diagnostic tests for various infectious diseases. The company is on the frontline of the global battle against the devastating AIDS pandemic.
The company announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid test Pre-Market Applications (PMAs). The approved PMAs allow Chembio to market its rapid HIV tests to clinical laboratories and hospitals in the United States.
SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid tests are easy to perform. They are highly sensitive (99.7% for HIV-1 and 100% for HIV-2) and specific (99.9%). The tests have a rapid turnaround time of approximately 15 minutes. They are safe to use, requiring a very small sample of whole blood (as little as 2.5-5.0 micro-liters which is approximately 1/10 of a drop of blood), easily obtained with a finger prick. Chembio's FDA PMA approval is for use not only with finger-stick whole blood samples but also with venous whole blood, serum and plasma samples. Both products have a built-in internal control, which gives confirmation of sample addition as well as valid test performance.
Chembio's tests uniquely offer a 24-month shelf life from date of manufacture at 46-86 degrees Fahrenheit, a significant advantage over other products currently on the market. This advantage may become more important if rapid HIV tests such as Chembio's are approved for the over the counter markets in accordance with guidelines that the FDA's Blood Products Advisory Committee (BPAC) recently recommended.
Rapid tests can detect HIV antibodies within minutes, the massive prevention and treatment programs that are now scaling up can be much more effective by providing results for earlier treatment. Chembio is one of four recommended global rapid HIV test suppliers under the Clinton HIV/AIDS Initiative. The company also manufactures additional rapid tests that it has developed for other deadly diseases, including human and veterinary Tuberculosis and Chagas Disease. Chembio is located at 3661 Horseblock Road, Medford, NY 11763.
The Emerging Stock Report profiles emerging growth companies and brings them to the attention of the investment community ahead of the market providing concise analysis and resources required in determining when a stock appears poised for growth.
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Chembio to Participate in the United Nations High Level Meetings on AIDS Wednesday May 31, 7:55 am ET
MEDFORD, N.Y.--(BUSINESS WIRE)--May 31, 2006--Lawrence Siebert, President and CEO of Chembio Diagnostics, Inc. (OTCBB:CEMI - News), was selected as a private sector delegate to the United Nation's High Level Meetings on AIDS to be held on May 31st - June 2nd, 2006 in New York. This is the first time that the private sector has been incorporated into the United Nation's High Level Meetings, with representation in plenary meetings, panel discussions, round tables, and interactive hearings.
The meetings are a follow-up on the implementation of the Declaration of Commitment on HIV/AIDS, adopted by UN Member States in 2001 at the UN General Assembly Special Session on HIV. The UN Secretary-General will present a report to the General Assembly on progress toward realizing the targets set out in the Declaration. The meeting will also identify common challenges to scaling up and sustaining national AIDS responses. Member States will consider recommendations on how to scale up HIV prevention, care and support with the aim of coming as close as possible to the goal of universal access to treatment by 2010 for all those who need it. Additional information about the meetings can be found at www.un.org/ga/aidsmeeting2006.
Mr. Siebert commented, "It is an honor to be able to participate in these meetings and work with the United Nations to help combat AIDS. Access to treatment is increasing but treatment goals have yet to be reached. Rapid HIV tests can identify those that are in need of treatment and therefore help achieve those goals."
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"This is the first time that the private sector has been incorporated into the United Nation's High Level Meetings, with representation in plenary meetings, panel discussions, round tables, and interactive hearings."
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