The following is a review of diagnostic product developments worldwide

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.

Biocircuits Corp, Sunnyvale, CA has received clearance from the U.S. FDA to market its Quantitative hCG assay and TSH assay on the IOS immunodiagnostic system that allows testing in physicians' offices and other points of patient care.

Biopool International, Ventura, CA has received U.S. FDA approval to market their new Chromolize PAI-1 Assay Kit, which measures the level of plasminogen activator inhibitor-1 (PAI-1) in blood. Plasminogen activator inhibitor-1 is one of the most important naturally occurring proteins regulating fibrinolysis. It does so by modulating the activity of tissue plasminogen activator (tPA), which is the body's key enzyme responsible for the dissolution of blood clots.

Healthcare Technologies, Ashdod, Israel has launched, SeroCP, an ELISA-based kit for the diagnosis of chlamydia pneumonia - a bacterium that may play a significant role in heart disease, chronic bronchitis and asthma - amid enthusiastic interest. The test detects chlamydia pneumonia IgG, IgA, and IgM antibodies

Cortecs International, London , UK has signed an exclusive agreement with Cancer Research Campaign Technology Limited for the development of diagnostic tests for nasopharyngeal cancer (NPC). Cortecs plans to initiate a program aimed at developing and commercializing a series of diagnostic products, using whole blood, plasma, serum or saliva, suitable to assist in diagnosing NPC.

Cardiovascular Diagnostics, Raleigh, NC has received a research grant award of $750,000 from the National Institutes of Health. The grant will be used over the next two years to fund further development and clinical field trials of new diagnostic systems for rapid monitoring of thrombin inhibitor agents. These drugs are used as anticoagulants to prevent thrombosis.

Dade MicroScan has received FDA approval for a new strep test for antimicrobial susceptibility of three different classes of streptococcus including Streptococcus pneumonia, viridans streptococci and beta-hemolytic streptococci.

Vysis, Inc., Downers Grove, Ill has received clearance from the U.S. FDA to market their CEP 8 Spectrum Orange DNA Probe Kit, to identify and enumerate abnormal chromosomes of leukemia patients. CEP 8 is the first IVD test utilizing Fluorescence In Situ Hybridization (FISH) technology available for clinical use. Used on patient samples of bone marrow, the test provides information useful in assisting the management of the patient's disease.

Researchers at Graz University, Austria evaluated the accuracy of six commonly used home glucose monitors in the measurement of hypoglycemia and reported that all six failed to meet the American Diabetes Association's criteria for accuracy. They found that, of the six, the One Touch II (LifeScan), Refloflux (Boehringer Mannheim), HemoCue (HemoCue) and Accutrend (Boehringer Mannheim) performed at the highest level, yielding measurements closest to the chosen reference method--the Beckman Glucose Analyzer 2. Meters that yielded the most variable results in terms of the reference value were the Companion II (MediSense) and Elite (Bayer) meters. The American Diabetes Association has recommended that home glucose monitors have a target variability or error rate that does not exceed 5%. They found that none of the evaluated devices met these criteria at blood glucose levels [below] 3.89 mmol/l. Source: Diabetes Care 1996;19:1412-1415.

HEMISPHERx, Philadelphia, PA has received patent approval on its Chronic Fatigue Syndrome (CFS) diagnostic, Diagen, in ten European countries. The Company believes that the Diagen technology should be the first accurate and direct diagnostic for CFS. The assay tests a patient's peripheral blood cells for specific immune deficits believed to be characteristic of CFS and evidencing an abnormal viral footprint.

Mosaic Technologies, Boston, Mass has developed a fiber-optic biosensor for analyzing multiple DNA sequences, simultaneously and allows fast (10 minutes) and sensitive (10nM) detection of multiple DNA sequences simultaneously. The company's preliminary commercial focus is development of DNA cytokine test kits to replace antibody-based cytokine assays. The assay uses Bridge Amplification, Mosaic's proprietary PCR process, a solid-phase application of the conventional liquid- phase PCR process.

Chromatics Color Sciences International, New York has developed the Colormate III, a transcutaneous bilirubinometer. The company is seeking FDA marketing clearance for use of the Colormate III in the noninvasive monitoring of bilirubinemia in newborn babies.

Beacon Diagnostics, Foster City, CA has signed an exclusive worldwide agreement for saliva-based cancer screening tests with Centocor, Inc. using Centocor's tumor markers in the development, manufacturing, and distribution of products for the detection of gastrointestinal, prostate, breast and ovarian cancers. Beacon has gained the rights to five of Centocor's tumor markers: CA 19-9 and CA 72-4 for gastrointestinal cancers, especially of the pancreas and stomach, Prostate Specific Antigen (PSA) for prostate cancer, CA 15-3 for breast cancer, and CA 125 for ovarian cancer.

Avitar, Wallingford, Conn has begun to market a saliva collection system for DNA testing. The system will be sold for use as a component in the performance of DNA amplification techniques for the determination of paternity, the detection of genetic disorders, the detection of infectious diseases, and forensics.

Product developments - November 1996
Product developments - October 1996
Product developments - September 1996
Product developments - August 1996
Product developments - July 1996
Product developments - June 1996