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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 February 1997

Abbott Laboratories has acquired Alcyon Analyzer S.A., Saint Mathieu de Treviers, France a manufacturer of benchtop clinical chemistry analyzers. Alcyon manufactures line of three, automated, clinical chemistry instruments.

 Affymetrix, Santa Clara, Ca and Hewlett-Packard Company, Palo Alto, CA have announced that HP's G2500A GeneArray scanner is now available as a part of the Affymetrix GeneChip System. The scanner can read DNA probe arrays containing more genetic information and can scan faster than was previously possible by other commercial scanners. Affymetrix intends to market a jointly developed GeneChip assay for analysis of p450 drug metabolism genes.

AMDL, Tustin, CA, has launched five in vitro diagnostic tests for the management of cancers of the prostate, colorectum, liver and testicle. AMDL's new tests include the: CEA Diagnostic Kit for the detection of carcinoembryonic antigen, PSA Diagnostic Kit to determine the presence of prostate specific antigen, Total BETA-hCG Diagnostic Kit for testicular cancer, AFP Diagnostic Kit to detect alpha-fetoprotein and the Ferritin Diagnostic Test Kit to detect ferritin. Elevated levels of both AFP and ferritin can be associated with liver cancer.

 ChemTrak, Sunnyvale, CA is introducing ColoCARE, a home test for the early detection of colorectal disease which is FDA-cleared. The ColoCARE test is easy to use, sanitary and reliable. Used in the privacy of the bathroom, the user simply removes the test pad from its envelope and drops it into the toilet following a bowel movement and before flushing. Chemicals in the pad cause it to turn blue within 30 seconds if occult blood is present in detectable amounts.

American Biogenetic Sciences, Copiague, NY has developed a patented Functional Intact Fibrinogen (FiF) test for the quantitative determination of fibrinogen in human plasma.

Gen-Probe, San Diego, CA has received US FDA clearance to market the Gen-Probe Amplified CT Assay, a new amplified Chlamydia test. The test can detect as few as one Chlamydia organism present in a patient's urine or swab sample.

Hemagen Diagnostics, Waltham, Mass, has received FDA clearance to market its VIRGO ELISA CMV IgG kit. The test detects current or past cytomegalovirus (CMV) infection.

 Somatogen, Bolder, Co, is developing Optro, recombinant human hemoglobin, designed to deliver oxygen and restore volume in the treatment of acute blood loss associated with surgery. The company is conducting a late Phase II, multi-center, intraoperative blood loss study in North America,

Hybritech , a wholly owned subsidiary of Beckman Instruments Inc., was issued a patent on Dec. 31, 1996, for monoclonal antibodies that recognize the bone-specific isoenzyme of alkaline phosphatase.

Instrumentation Laboratory has received FDA clearance to market the Synthesis family of Critical Care instruments. The Synthesis integrates blood gas and electrolyte tests with on-line CO-Oximetry.

Marquette Medical Systems, Milwaukee, Wis and Diametrics Medical, St. Paul, Mn, have announced that they will collaborate on the development of an interface that links the technologies of their existing product lines. Marquette, a manufacturer of bedside vital signs monitors and clinical information systems, will integrate data at the point of care from Diametrics' IRMA SL blood testing unit via the interface into their Unity Network.

Meridian Diagnostics, Cincinnati, Ohio has received FDA clearance to market ImmunoCard H. pylori-WB, a rapid test for detecting Helicobacter pylori antibodies from a finger-stick whole blood sample.

 Oncor, Gaithersburg, Md, has been issued a patent covering the use of genetic mutations for the detection of lung cancer cells using sputum samples. The test provides a non-invasive, rapid, method for detecting mutant nucleotide sequences found in lung cancer cells. The technology can identify one cell carrying a mutant gene among a large number (greater than 10,000) of normal cells.

Pace Corp., Toronto, has received U.S. FDA approval for its rapid and quantitative Myoglobin cardiac diagnostic test. This is the second Pace test to be approved by the FDA of four separate rapid quantitative cardiac diagnostic tests to be marketed in a staged launch as the CARDIOLOGIC System. The system also includes a low cost, menu-driven data reader and quality control reagents.

Pharmacia has received U.S. FDA clearance to market a laboratory blood test for latex allergy. The ImmunoCap serum test can identify immunoglobulin E antibodies (IgE) specific to latex allergies.

The US FDA has approved Genetics Institute's, Cambridge, Mass, BeneFix a genetically engineered version of Factor IX.

Behring Diagnostics has added 12 additional Emit assays for the SYVA-30R analyzer including: four new protocols for quantitating tricyclic antidepressants, serum barbiturate, benzodiazepine, and acetaminophen assays.

Technical Chemicals & Products, Inc., Pompano Beach, Fla and its wholly owned subsidiary, Health-Mark Diagnostics have launched the HealthCheck brand of over-the-counter diagnostic and health screen products. The HealthCheck line is being introduced in the United States with 14 accurate and easy to use products for consumers which consist of at-home, diagnostic tests and screens for cholesterol, diabetes, urinary tract infection, pregnancy, ovulation, deteriorating vision and abnormal skin growth, as well as a series of health journals design to educate and keep track of important health information.

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* 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: March 3, 1997