CEMI - mit Bluttests an die Spitze

Die aktuellen Notierungen der Chembio Diagnostics Systems-Aktie liegen gerade mal 20% höher und bieten eine ideale Gelegenheit, es dem Insider umgehend gleichzutun, so die Experten von "Global Biotech Investing". (Ausgabe 11 vom 09.06.200 (10.06.2008/ac/a/a) Analyse-Datum: 10.06.2008







Dazu hat man mit Bio-Rad Laboratories, Inc. ("Bio-Rad" (AMEX: BIO) einen milliardenschweren Partner an der Seite!

 

Meldung vom April:

Chembio Signs Exclusive DPP(TM) Development Agreement With Bio-Rad Laboratories, Inc.

Chembio Diagnostics, Inc. (OTC BB: CEMI) ("Chembio" or the "Company" announced today that it has signed an exclusive development agreement with Bio-Rad Laboratories, Inc. ("Bio-Rad" (AMEX: BIO) and (AMEX: BIOb) to develop a multiplex test employing Chembio's patented DPP(TM) Dual Path Platform test system. The test would also employ certain proprietary reagents belonging to Bio-Rad. The agreement contemplates that the parties would enter into a limited exclusive license to the DPP(TM) technology. Bio-Rad would have exclusive marketing rights for the product.

According to Chembio Chief Executive Officer Larry Siebert, "This collaboration with a world market leader like Bio-Rad is a good fit for Chembio, as it allows us to leverage our DPP intellectual property with our experience in product development and regulated manufacturing to develop a product to be marketed by a leading diagnostics company."

ABOUT DPP

The Dual Path Platform immunoassay is a recent Chembio innovation in the field of rapid testing for which the company received a U.S. patent in 2007. DPP(TM) technology employs two separate and distinct membrane strips, one for the sample migration and one for the test reagents. This unique dual-flow design allows for improved control and management of the sample flow. As a result, the immunological reaction is more efficient than lateral flow tests based upon studies performed by Chembio.

ABOUT CHEMBIO

Chembio Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic tests, participates in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third-party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP(TM)) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(TM). Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

FORWARD-LOOKING STATEMENTS

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner, and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.
Company Contact:
Chembio Diagnostics, Inc.
Susan Norcott
(631) 924-1135, ext. 125
(www.chembio.com)
Source: Marketwire (April 16, 2008 - 8:30 AM EDT)
News by QuoteMedia
www.quotemedia.com





Der Hiv-Test ist nicht das einzige Produkt - hier mal die Übersicht von der Homepage www.chembio.com

HUMAN DIAGNOSTICS PRODUCTS :

CHAGAS STAT-PAK® ASSAY
HIV 1/2 STAT-PAK® ASSAY
HIV 1/2 STAT-PAK® DIPSTICK
HIV 1/2 SURE CHECK®
SICKLE-STAT
TB STAT-PAK®II
ANIMAL / VETERINARY DIAGNOSTICS PRODUCTS :

BOVID TB STAT-PAK
BROCK TB STAT-PAK
CAMELID TB STAT-PAK
CERVID TB STAT-PAK
ELEPHANT TB STAT-PAK
PRIMA TB STAT-PAK
aviel verspricht man sich auch von der neu entwickelten Technologie:



DUAL PATH PLATFORM (DPP*) TECHNOLOGY
DPP Information
*Patent applications in the US and several foreign jurisdictions worldwide have been on file since March 2005

CHEMBIO has developed a new and innovative chromatographic immunoassay technology--Dual Path Platform (DPP)--for rapid diagnostic testing of a wide variety of analytes.  This technology offers significant advantages over current conventional Lateral Flow (LF) assays.





Hier noch zwei Präsentationen von der Homepage



Investor Präsentation )hier ist auch die genauigkeit des Tests beschrieben - man ist genauso gut wie der Markführer)
library.corporate-ir.net/library/12/121/121584/items /274982/Chembio%20Fact%20Sheet.pdf



FactSheet:

media.corporate-ir.net/media_files/irol/12/121584/InvestorP resentation11_07.pdf



Das Produkt HIV-Test ist ausgereift - sie waren schon letztes Jahr auf der internationalen Aids Konferenz in Mexico City vertreten und werden auch dieses Jahr wieder dort sein - noch was außergewöhnliches für ein OTCBB Unternehmen

Hier gibt es ein sehr interessantes Interview mit Lawrence A. Siebert, President and Director von Chembio, zu sehen

www.onemedplace.com/database/list/cid/2373/



Das ist ja ne richtige Perle die Chembio  ;)

Die für 0.25 sind weg  ;)

Bid Level #MM's Size  Ask Level #MM's Size
0.2400 1 50  0.2570 1 50
0.2350 1 50  0.2650 1 50
0.2200 1 50  0.2750 1 50
0.2000 1 50  0.2900 1 50

Von vor ein paar Tagen:

Finanzen.net
Chembio Diagnostics dranbleiben
Dienstag 8. Juli 2008, 08:43 Uhr




Endingen (aktiencheck.de AG) - Die Experten von "Global Biotech Investing" raten, an der Aktie von Chembio Diagnostics (ISIN US1635721004/ WKN A0JMX3) dranzubleiben.
Der Biotech-Titel habe seit Mitte Mai zu einer Kurserholung auf ein Zwischenhoch von 0,25 USD zugelegt. Doch nach Meinung der Experten dürfte dies noch nicht das Ende der Fahnenstange gewesen sein.

Denn so seien kürzlich gute klinische Zwischendaten zu einem HIV-Test für Jugendliche veröffentlicht worden.  
Der Test für Erwachsene habe bereits die Marktzulassung erhalten und seine US-Umsätze seien in Q1'2008 um 89% gestiegen. Daher wäre ein Erfolg als Beleg für die Qualität für die Plattformtechnologie von Chembio Diagnostics zu werten. Für diese habe man sogar kürzlich den Bio-Rad-Konzern als Forschungspartner gewinnen können.

Die Experten von "Global Biotech Investing" empfehlen, an der Aktie von Chembio Diagnostics dranzubleiben. (Ausgabe 13 vom 07.07.2008)
(08.07.2008/ac/a/a)
Analyse-Datum: 08.07.2008

Total revenues for the first half of 2008 were $5.08 million, an 11.9% increase compared with first half 2007 total revenues of $4.54 million. First half 2008 revenue growth came from $259,000 of increased product revenues and $283,000 of increased research and grant revenues. The increased product revenues for the first half of 2008 included an increase in rapid HIV test revenue of $171,000 to $4.13 million or 4.3% from $3.96 million in the same period of 2007. In addition, revenues from Tuberculosis tests increased by $59,000 in the first half of 2008 compared with the same period in 2007.

The net loss attributable to common stockholders decreased 43.8% to $1,161,000, or $0.02 per share, for the first half of 2008 compared to a net loss attributable to common stockholders of $2.07 million or $0.17 per share for the first half of 2007. The net loss attributable to common stockholders for the first half of 2007 included $711,000 in non-cash dividends to preferred stockholders. As previously reported, all of the Company's convertible preferred stock was converted into common stock in December 2007, which resulted in no preferred stock dividends in the first half of 2008.

Second Quarter and Recent Highlights

-- In addition to posting record quarterly total revenue, in the second
quarter of 2008 the Company posted its lowest quarterly operating loss
since the merger with Chembio Diagnostic Systems, Inc. in May 2004.
-- Strong sales of rapid HIV tests to Brazil and Africa offset decreased
sales of these products in the US. The decreased sales in the US are
due to a slower ramp in US rapid HIV test sales. The slower ramp is
partially due to the delay in obtaining the approval of our PMA
supplement to expand our HIV age testing range to include 13 to 17 year
olds. As reported in June we completed the required clinical study for
submitting this. In July we submitted the PMA supplement to the FDA,
and we are now waiting for its review to be completed. This change,
together with multiple initiatives by our marketing partner to expand
distribution of our products, and now new studies by the United States
Centers for Disease Control reported this past weekend of a 40%
under-reporting of HIV incidence in the United States, should increase
potential sales opportunities in the U.S. over the long term.
-- We remain bullish about our potential increased participation in the
global, as well as domestic, rapid HIV test market. We are pleased with
the more than tripling of the PEPFAR (U.S. President's Emergency Plan
for AIDS Relief) program signed into law last week by the President to
$48 billion over the next five years, and with the increased emphasis on
testing that is in the new legislation. As the only US-based
manufacturer of competitively priced rapid HIV tests, we look forward to
the potential of increased participation in PEPFAR.
-- Gross Profit increased 30.75% to $1,296,000 reflecting improved average
unit selling prices and continued improvements in manufacturing
efficiencies compared to a year ago.
-- Operating Loss decreased 44% to $365,259 as operating expenses (R&D and
SG&A) increased less than 1% from the second quarter of 2007.
-- All studies required to file for CE Marking of our FDA-approved HIV
tests are now complete. The CE marking certifies that a product has
met European Union health, safety, and environmental requirements. We
anticipate submitting the technical file very soon and therefore
receiving CE marking this year
-- Our patented DPP® platform is providing the Company with an historic
number of new product opportunities:
-- We have completed development of the three DPP® products in
connection with our contract with the Brazilian Ministry of Health;
tests for antibody detection of canine Leishmaniasis, Leptospirosis
and our first multiplex DPP® test, which is a point of care test
for the confirmation (as compared with screening) of HIV. We are in
the process of validating these initial products in order to scale
up their manufacture during the third and fourth quarter. Our current
forecast is to generate at least $500,000 of product and license
revenues from these products during the balance of 2008.
-- We have completed development of our DPP® HIV screening test as a
result of the successful conclusion of preclinical trials we
conducted during the second quarter. We are now validating this
product for production scale-up as well, and finalizing product
inserts and packaging so that export sales can begin as soon as
possible. We also are in discussions with potential marketing
partners for this product in the United States, which would require
a new PMA submission.
-- We have made excellent progress on the product development project
we entered with Bio-Rad Laboratories, Inc. We anticipate completing
the initial phase of this development during the next couple of
months, and thereupon proceeding to a long-term development and
license agreement with Bio Rad.
-- We are also completing development of our Syphilis screen and
confirm test and have several new OEM product opportunities under
discussion for DPP®. We are seeing an increasing interest in the
combination of our intellectual property with our development and
manufacturing capabilities.
-- During the second quarter we also received from the United States
National Institutes of Health a $296,000 grant for development of a
DPP® TB test.
-- The United States Patent and Trademark Office (USPTO) issued Chembio
an additional patent during the second quarter covering a point of
care rapid test platform that serves to broaden our intellectual
property coverage.
-- The USPTO also issued us the registration of our DPP® trademark,
enabling increased protection for this intellectual property.

Lawrence Siebert, President and CEO, commented, "We are pleased at the continued improvements from our base lateral flow business as we approach realizing new revenue streams from our DPP® products. We expect to continue this momentum despite a difficult economic environment as our products serve a global market. On a personal note, I am deeply saddened by the passing of Alan Carus, who was an outstanding and valued member of our Board of Directors and chairman of our Audit Committee since 2005. Al worked tirelessly, was a tremendous asset to Chembio, and he will be sorely missed."

Conference Call

As previously announced, Chembio has scheduled a conference call and webcast for 4:30 p.m. Eastern time on Monday, August 4, 2008. Participants may access the call by dialing (877) 407-0782 from the U.S. or (201) 689-8567 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until August 11, 2008 at 11:59 p.m. Eastern Time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S. and entering reservation account number 286 and conference ID 292790. The conference call may also be accessed via the internet at www.investorcalendar.com/IC/CEPage.asp?ID=132435. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

ABOUT CHEMBIO

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a third-party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio also has rapid tests for veterinary tuberculosis and chagas disease. In 2007 Chembio received a U.S. patent for its Dual Path Platform (DPP®) technology which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP™. Headquartered in Medford, NY, with approximately 100 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485.

Forward-Looking Statements

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing, to obtain regulatory approvals in a timely manner and the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

(Tables to follow)


Chembio Diagnostics, Inc.
Summary of Results of Operations


For the three months ended For the six months ended
-------------------------- --------------------------
June 30, June 30, June 30, June 30,
2008 2007 2008 2007
============ ============ ============ ============
Total Revenues $ 2,717,784 $ 2,502,773 $ 5,082,512 $ 4,541,093

Gross Profit $ 1,296,809 $ 991,900 $ 2,358,731 $ 1,651,718

Operating Loss $ (365,259) $ (654,597) $ (1,176,828) $ (1,565,735)

Net Loss $ (363,129) $ (625,856) $ (1,161,311) $ (1,354,662)

Preferred
Dividends, Deemed
Dividends and
Beneficial
Conversion Feature - $ 356,900 - $ 710,878

Net Loss
Attributable to
Common
Stockholders $ (363,129) $ (982,756) $ (1,161,311) $ (2,065,540)

Loss per share $ (0.01) $ (0.08) $ (0.02) $ (0.17)



Chembio Diagnostics, Inc.
Summary of Balance Sheet


June 30, December 31,
2008 2007
============== ==============
CURRENT ASSETS:
Cash $ 954,157 $ 2,827,369
Other current assets 3,195,964 2,643,938
-------------- --------------
TOTAL CURRENT ASSETS 4,150,121 5,471,307

NET FIXED ASSETS 964,542 829,332

OTHER ASSETS 1,103,970 284,358
-------------- --------------

$ 6,218,633 $ 6,584,997
============== ==============

TOTAL CURRENT LIABILITIES $ 2,323,476 $ 2,242,583

TOTAL OTHER LIABILITIES 570,519 79,588
-------------- --------------

TOTAL LIABILITIES 2,893,995 2,322,171

TOTAL STOCKHOLDERS’ EQUITY (DEFICIENCY) 3,324,638 4,262,826
-------------- --------------

$ 6,218,633 $ 6,584,997