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.

Adeza Biomedical, Sunnyvale, CA announced that the US FDA approved their premarket approval application for expanding the intended use of Adeza's diagnostic test to detect the risk of preterm delivery to include women without symptoms of preterm labor. The test detects the presence of fetal fibronectin (fFN), which has been in the vaginal secretions of women between 24 and 34 completed weeks of pregnancy.

Affymetrix, Inc. has entered into a collaboration with Glaxo Wellcome collaborating to understand the correlation between mutations in the HIV virus and response to antiviral drugs. The collaboration will use Affymetrix' proprietary GeneChip technology to build a database of genetic information from a selected sampling of patients with the virus.

Baxter Healthcare Corporation has received clearance from the U.S. FDA to market a blood-collection device that is quicker, easier to use and results in higher-quality platelet products. The Amicus separator prepares leucoreduced platelet preparations without the need for a second filtration step.

Biocontrol Technology, Pittsburgh, PA has launched an in-home study with the Diasensor 1000 noninvasive glucose sensor.

Biota Holdings, Melbourne, Australia is partnering with BioStar, Boulder, Colorado, for the development of a point-of-care diagnostic test for all strains of influenza. The test uses Biostar's proprietary Optical ImmunoAssay system.

A healthcare team at the University of California San Francisco has developed a noninvasive testing to uncover and measure hidden heart risks. Called the Cardiovascular Health Assessment and Modification Program (CHAMP), the testing is available at three levels depending on the patient's health and medical history, and is geared to detecting heart disease in the absence of symptoms. CHAMP measures traditional areas such as blood pressure, serum lipids, lipoprotein (a) and features Ultrafast CT for looking at asymptomatic coronary artery plaque.

Chiron has acquired a sublicense from ImClone Systems, New York, to use the company's Ampliprobe DNA probe technology.

Cortecs International, London, U.K. has launched the Helisal One Step rapid point-of-care test for Helicobacter pylori. A fingerstick blood sample is collected on a comb-shaped key which is then pushed into the Helisal One Step body and snapped shut. The result can then be read within five minutes

Dade MicroScan Inc. has received U.S. FDA clearance for the Dade MICroSTREP Panel, a test for three strains of streptococcus infection. The panel tests for antimicrobial susceptibility of three different classes of streptococcus.

Dr. Brown's Home Drug Testing System, an over-the-counter test for drug use has received US FDA market approval. The kits will reach drugstores within six weeks and will cost less than $30. Consumers will mail a urine sample in a protective tamper-proof package to a government-certified laboratory. One to three days later, consumers, using a code number to preserve anonymity, call an 800 number for the results.

Body Ammo, the leading manufacturer of over-the-counter DHEA, in conjunction with National BioTech Laboratory, Seattle, Washington, is introducing a new program to help consumers figure out exactly how much DHEA their bodies need -- the Salivary Hormone Test. The kit includes a vial, some gauze and a mailer box to the vial to the laboratory for testing. The lab sends back a comprehensive DHEA analysis that includes what average DHEA levels should be at any given age, so the consumer will know just how much DHEA his (or her) body needs.

Vysis, Inc., Downers Grove, Ill, announced it received clearance from the U.S. FDA to market the company's CEP 12 Spectrum Orange DNA Probe Kit, for use as an adjunct to standard cytogenetic analysis to identify and enumerate chromosome 12 in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL).

Instrumentation Laboratory has introduced the ACL 6000 system. This compact, benchtop analyzer performs clotting and chromogenic assays and includes system features such as autodilution and an on-board data management system capable of storing patient demographics and results.

Intelligent Medical Imaging , Palm Beach Gardens, Fl has received clearance from the US FDA to market the MICRO21 system for nDNA analysis. The nDNA screen is a indirect enzyme antibody test for the semi-quantitative detection of nDNA antibody in human serum. This procedure is used in the detection of systemic rheumatic disease, such as lupus erythematosis and other connective tissue diseases. It automates microscopic procedures including White Blood Cell Differential Analysis, WBC Morphology, Red Blood Cell Morphology, Platelet Estimates, Reticulocyte Count, ANA Analysis and nDNA Analysis.

Marquette Medical Systems Milwaukee, Wis, has developed a connectivity device that provides hospitals with a quick, simple interface between their existing bedside medical equipment and clinical information systems. The Octacomm allows automatic plug and play connectivity of up to eight bedside components such as patient vital signs monitors, ventilators, infusion pumps, etc. No user configuration

or device re-booting is required.

Mosaic Technologies, Boston has entered into a product-development agreement with Boston University's Center for Photonics Research. Mosaic and BU will build a multiple-test, second-generation, fiber optic-based DNA sensor to detect virus- or organism-infected blood from donors. The test is based on Bridge amplification, Mosaic's proprietary process, which is a novel solid-phase application of the conventional liquid-phase PCR technology.

Optical Sensors, Minneapolis, MN, has received clearance from the U.S. FDA to market its new OpticalCAM arterial blood gas monitoring instrumentation. The system uses the SensiCath Sensor, a patient-attached, on-demand arterial blood gas monitoring system, which provides precise, accurate results within 60 seconds without exposure to potentially infectious blood or depleting the patient's blood supply.

A study published today in the Journal of the American Medical Association shows that the OraSure HIV-1 Antibody Testing System, the first oral HIV antibody test, is a highly accurate alternative to blood testing. The OraSure HIV-1 Western Blot Kit was cleared by the FDA last June, and is marketed by SmithKline Beecham Consumer Healthcare. The technology uses a sample called oral mucosal transudate (OMT), not saliva.

Furu-Steri Corp., Osaka, has developed a disposable Petri dish made of biodegradable plastic. The new plastic Petri dishes, made using a lactic acid-based biodegradable plastic developed by Shimadzu Corp. (7701), are sterilized with gamma radiation. The cost of a dish about 50 cents.

Roche Molecular System's Amplicor PCR tuberculosis test is the second to be approved for market. It will be sold at $25/test, the same as Gen-Probe's product, the other gene amplification tuberculosis test on the U.S. market.

Trinity Biotech, Dublin, Ireland, has signed an agreement with Calypte Biomedical to develop a one-step urine based HIV test. The collaboration combines Calypte's expertise in urine assay development for HIV with Trinity's expertise in developing one-step rapid tests for HIV. Calypte is the only company with an FDA licensed laboratory based urine HIV test. Trinity is the only company to have submitted a rapid one-step whole blood HIV test to the FDA for approval.

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