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The following is a review of diagnostic product developments worldwide

The information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.

The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.

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Product developments in January 1999

American Bio Medica Corporation has received FDA clearance to market its 9 panel Rapid Drug Screen. The 9 panel test will be marketed to clinical sectors worldwide by Abbott Laboratories. The 9 panel Rapid Drug Screen tests for the presence or absence of THC, cocaine, opiates, PCP, amphetamines, benzodiazepines, methamphetamines, barbiturates, and tricyclic antidepressants.

Amira Medical has received FDA market clearance for The Amira Medical AtLast Blood Glucose System, the first blood glucose monitoring system that eliminates painful fingersticks. The AtLast System's all-in-one meter and sampler design uses a unique disposable test strip to make it easy to obtain a small blood sample from the forearm, thigh or upper arm. Joel Douglas, chief technology officer and co-founder of Amira Medical explained, "by using micro-components to integrate the optics, electronics and strip design into a single product, the elimination of fingersticks became practical." The AtLast System will be available in the second quarter of 1999.

Biopool International Inc. has entered into a supply agreement with i-STAT Corp. to provide specialized control products designed for use on the hemostasis cartridges and instruments currently under development at i-STAT. Michael D. Bick, Ph.D., chairman and chief executive officer of Biopool, stated: "Biopool developed these customized plasma control products to support the i-STAT test system during 1998 and, indeed, received FDA clearance on the products in June of last year. Since that time, we have delivered product to i-STAT to support their ongoing clinical evaluations. Full commercialization of the test system is expected to begin late in 1999."

ChemTrak Inc. is developing AccuMeter -- quantitative, whole blood rapid tests for the detection of antibodies or antigens in infectious diseases such as HIV, HBV and HCV. Clinical samples were tested in AccuMeter and ELISA with additional confirmation by Western blot for HIV. A 100% correlation was observed with 40 specimens (17 positives and 23 negatives) in HCV, 50 specimens (22 positives and 28 negatives) for HBsAg, and 344 specimens (70 HIV-1, one subtype 0, and nine HIV-2 positives, and 264 negatives) in HIV.

Diagnostic Products Corporation has acquired a non-exclusive license for Bio/Data Corporation's microfiltration technology. Under terms of the agreement, DPC will take a minority equity position in Bio/Data Corporation. Michael Ziering, President of DPC, said, "Microfiltration reduces the time required to produce plasma from, nominally, 20 minutes to 17 seconds, without the centrifugation of the patient whole blood sample. This agreement is significant because it gives DPC access to a key technology that meets our ongoing objectives of reducing total test processing time and improving operator convenience for our automated IMMULITE diagnostic systems."

Gen-Probe, Chiron and the American Red Cross (ARC) have reached an agreement that will see the ARC begin to use Gen-Probe's semi-automated amplified DNA probe test to help detect HCV and HIV-1 RNAs in pooled samples of plasma from blood donations. Investigational protocols have been submitted by Gen-Probe and the American Red Cross to the FDA for review and the implementation of the test by the Red Cross is expected to occur in early 1999.

International Medical Innovations Inc. is developing a test for CA1-18, a serum tumour marker for the early detection of colorectal and lung cancer. Clinical trials assessing the use of CA1-18 for the screening of colorectal cancer are underway at St. Michael's Hospital in Toronto. IMI also has licensed patents for RMT, a mucous test for the detection of several cancers, including colorectal cancer.

NeuroMetrix Raises $11.5 Million in Second Round Venture Financing: NeuroMetrix, Inc., is developing a new class of non-invasive products for point-of-care testing of neuromuscular disorders. The Company anticipates that its technology will provide physicians with immediate and cost-effective information to be used as an aid in the diagnosis of common neuromuscular conditions including repetitive stress injuries, peripheral and toxic neuropathies and low back pain. The first product, NC-stat is expected for full commercial release Q2 1999.

Quantech, Ltd. has filed a 510k application with the FDA for clearance to market a rapid, quantitative total beta-hCG pregnancy test to be run on Quantech's DBx rapid diagnostic instrument, based on digital biosensor surface plasmon resonance (SPR) detection technology. The first tests scheduled to be available on the system will be the quantitative HCG test, a cardiac panel (CK-MB, troponin I and myoglobin), a white and red blood cell count panel, a coagulation panel and an amylase test.

Sysmex Corporation and Roche Diagnostics have signed a distribution agreement whereby Roche will represent the full Sysmex hematology product line exclusively in the United States as of February 1st, 1999. The agreement follows the signing of a global cooperation agreement in May, 1998, between Sysmex and Roche Diagnostics to form a strategic alliance for hematology instruments and associated products. Current customers of Sysmex instruments will continue to purchase reagents and controls through the company's current distributors, including Allegiance Corporation. Additionally, Sysmex announced that it has advised Dade Behring's Integrated Services Division of its intention not to renew a service agreement currently in place between Dade Behring and Sysmex to service non-Robotics Sysmex Hematology analyzers. Roche will assume responsibility for providing service for the full Sysmex hematology product line as of July 1st, 1999. The Coagulation Alliance between Sysmex and Dade Behring will continue in force with Dade Behring providing all sales, support and service for the Sysmex Coagulation product line in the U.S.

Shield Diagnostics Group Plc and Axis Biochemicals ASA have merged. The merger will be effected through the issue of one new Shield ordinary share for each Axis ordinary share, giving Shield shareholders 62% of the enlarged group and Axis some 38 percent, valuing the new group at $293 million US. The companies say the enlarged group will be a significant force in cardiovascular disease prediction, and allow substantial scope for synergies and strengthen research and development.

Worldwide Medical Corporation has launched its First Check Breath Alcohol Testers-0.08% to the retail, over-the-counter, consumer markets. The simple, two-minute breath test consists of a small plastic tube surrounding a glass ampule containing yellow crystals chemically treated to change color to a blue-green, if a person's breath alcohol would reach 0.08% or higher. Packaged three tests per box, the First Check Breath Alcohol Testers-0.08% will retail under $10.00. The Company plans to have the First Check Breath Alcohol Tester-0.08% in more than 5,000 retail outlets during the first quarter of 1999.

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* Product developments - December 1998
* Product developments - November 1998
* Product developments - October 1998
* Product developments - September 1998
* Product developments - August 1998
* Product developments - July 1998
* Product developments - June 1998
* Product developments - May 1998
* Product developments - Avril 1998
* Product developments - March 1998
* Product developments - February 1998
* Product developments - January 1998
* Product developments - July 1997
* Product developments - June 1997
* Product developments - May 1997
* Product developments - April 1997
* Product developments - March 1997
* Product developments - February 1997
* Product developments - January 1997
* Product developments - December 1996
* Product developments - November 1996
* Product developments - October 1996
* Product developments - September 1996
* Product developments - August 1996
* Product developments - July 1996
* Product developments - June 1996

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Last modified: January 31, 1999