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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 September 1996

Athena Medical Corp., Portland. Ore, announced that it has received clearance from the U.S. Food and Drug Administration to market its home pregnancy test called Affirm.

Biocircuits Corp, Sunnyvale, Ca said it has filed an application with the U.S. Food and Drug Administration for marketing approval of its Quantitative hCG test, which helps track the progress of early pregnancies. The test is designed to be used with Biocircuits' immunodiagnostic system to allow testing in doctors' offices and other patient clinics.

Biopool International, Ventura, CA has received U.S. Food and Drug Administration 510(k) approval to market the company's new Spectrolyse Antithrombin-III (anti-Xa) Assay Kit, a test system designed to assess, in a clinical setting, a patient's risk for developing blood clots.

Chiron, Ortho Diagnostic Systems and International Murex announced that the three companies have reached a worldwide agreement concerning tests for Hepatitis C virus (HCV) under which all litigation between the companies will permanently cease. The agreement grants Murex a license to sell HCV Serotyping tests worldwide and other HCV tests in selected countries excluding North America, European Economic Community members and Japan. The agreement also grants to the Chiron-Ortho joint business rights to the Murex Sample Addition Monitor technology as well as an option to sell Murex's HCV Serotyping test.

The University of Colorado has opened a Cord Blood Bank for the storage of umbilical cord and placenta blood. The blood contains stem cells which can be used in place of bone marrow stem cells for people undergoing bone marrow transplantation. A university press release explains that research suggests that cord stem cells may be safer than marrow cells because cord blood is so immature, it is less likely to cause graft-versus-host disease.

ImmuCell Corp., Portland, Maine, announced the formation of a joint venture with Membrex Inc., Fairfield, N.J. called Clearwater Diagnostics Company LLC to commercialize Crypto-Scan water diagnostic test, to detect the presence of Cryptosporidium parvum oocysts in drinking water.

Dynagen Inc. has filed for FDA approval for its urine-based NicCheck test, which provides results in 15 minutes It can be used by physicians and health maintenance organizations to check patients who say they have quit smoking. According to company sources NicCheck will cost $1 wholesale.

Gen-Probe Inc, San Diego, CA has signed a contract with RELA Inc., Denver, CO to design and develop an instrument which will utilize Gen-Probe's patented genetic probe technology for the diagnosis of STDs, TB, HIV, other infectious diseases, and various forms of cancer.

American Biogenetic Sciences, Inc., Copiague, NY and Gull Laboratories, Inc., Salt Lake City, UT, have signed an agreement for the manufacture and distribution of ABS' proprietary Thrombus Precursor Protein (TpP) assay in various automated plate formats. The TpP test measures blood levels of soluble fibrin polymer, the immediate precursor to a blood clot. Elevated blood levels of TpP may indicate imminent or ongoing pathological clot formation.

Hemagen Diagnostics Inc., Waltham, Mass., announced the allowance of a patent for Ligand/Anti-Ligand assays for adherent proteins. This is a novel method to determine microquantities of lipophilic proteins in patient serum -- the major apolipoproteins of HDL and LDL.

Hybritech Inc., San Diego, Ca, has received clearance from the U.S. Food and Drug Administration market Tandem-R Ostase, for the management of postmenopausal osteoporosis.

IGEN, Inc., Gaithersburg, MD announced that it has received FDA clearance for the Company's ORIGEN Analyzer and a line of reagents. IGEN's corporate partner, Boehringer Mannheim, recently received FDA clearance for its ORIGEN-based Elecsys 2010 system and related clinical immunodiagnostic tests for the clinical laboratory market.

Instrumentation Laboratory, Lexington, Mass., and Mallinckrodt Group Inc. announced they have signed a definitive acquisition agreement under which IL will acquire Mallinckrodt Sensor Systems.

Meretek, Inc., Nashville, Tenn, announced receipt of market clearance and approval for their diagnostic breath test for detection of the ulcer-causing bacterium, Helicobacter pylori, by the Food and Drug Administration. The MERETEK UBT Breath Test for H. pylori is the first and only breath test for diagnosis of H. pylori cleared and approved in the United States utilizing patented non-radioactive technology.

Metra Biosystems Inc., Mountain View, CA, announced an agreement with Amersham International plc to market Metra's bone metabolism immunoassays. Metra also announced that Ciba Corning Diagnostics Corp., has filed a 510(k) premarket notification with the U.S. Food and Drug Administration for clearance to market Metra's Pyrilinks-D bone resorption technology for clinical use on Ciba Corning's ACS:180 automated immunoassay system.

InMedica Development Corp, Salt Lake City, UT is developing a noninvasive blood monitoring device to measure hematocrit levels. InMedica's device is applied to the patient with a conventional blood pressure cuff and a disposable, detachable electrode that attaches to the patient's finger. Once the electrode is attached, it is possible to observe hematocrit levels, essentially in real-time.

Optical Sensors Inc. Minneapolis, MN announced that its marketing partner, Marquette Medical Systems, is now producing Online ABG modules for Marquette's Tramscope customers and Optical Sensors is now beginning to book sales of its SensiCath Sensor., a patient-attached, on-demand arterial blood gas monitoring system, which provides precise and accurate ABG results within 60 seconds without depleting the patient's blood supply.

Perkin-Elmer Corp, Norwalk, Conn., has introduced TaqMan Salmonella PCR Amplification and Detection System, an automated DNA-based test for specific and rapid detection of salmonella in food. The system can detect salmonella in less than 24 hours.

Nippon Telegraph and Telephone Corp., (NTT) Tokyo, has developed technology for freeze-drying red blood cells, enabling preservation for three months or more. Adding liquid reconstitutes the blood product. The technology could be used in preparing blood typing reagents.

Scios Inc., Mountain View, Ca, and Shionogi & Co., Ltd. announced the introduction in Japan of the first blood test for the diagnosis and monitoring of congestive heart failure. Shionogi is marketing the test, based on the detection of BNP (b-type natriuretic peptide) levels in the blood, for use in patients with acute heart failure. Scios is seeking additional licensees to develop BNP-based diagnostic tests. Cardiac and circulating blood plasma levels of BNP are elevated during heart dysfunction in both symptomatic (late-stage) and asymptomatic (early-stages patients.

TCPI Diagnostics, Fort Lauderdale, Fl, has launched the One Step Cardiac Troponin I Test (cTnl) which is performed with one drop of whole blood obtained from a finger-stick and produces test results in 10-15 minutes.

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