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.

Array Medical, Somerville, NJ has received FDA clearance to market their new Actalyke Activated Clotting Time Test (ACT) System. Designed for use at the point of patient care to monitor heparin anticoagulation therapy, the Actalyke system is comprised of a portable, battery-operated instrument and disposable tubes. Array Medical also markets the Ichor hematology analyzer, a miniaturized cell counter for

performing the Complete Blood Count (CBC) at the point of patient care.

Avitar, Inc, Canton, Mass. and Sun Biomedical Laboratories are developing saliva-based drugs of abuse tests. These tests incorporate Avitar's patent-pending saliva collection system.

Becton, Dickinson and Company has signed a definitive agreement with Difco Laboratories Incorporated, under which Becton Dickinson will acquire Difco.

Biosite Diagnostics, San Diego, Ca, has signed an agreement with Scios Inc. granting Biosite a license to certain technology and patents developed by Scios for use in developing a new point-of-care diagnostic for congestive heart failure. The test is based on the detection of B-type natriuretic peptide (BNP) levels in the blood, for use in hospital patients with acute congestive heart failure or acute exacerbation of chronic congestive heart failure (CHF).

BioStar, Inc., Boulder, Co, has entered into a joint marketing program with General Injectables and Vaccines, Inc. (GIV), a subsidiary of Biological and Popular Culture, Inc., to market BioStar's Chlamydia Optical ImmunoAssay (OIA) point-of- care test and Pfizer's antibiotic Zithromax, distributed by GIV. Under the agreement, the companies will combine the CHLAMYDIA OIA diagnostic test with the single-dose Zithromax treatment and offer the package to Planned Parenthood affiliates, public health facilities and university student clinics.

Boehringer Mannheim Corporation (BMC) has received 510(k) clearance from the FDA for its ultra sensitive CARDIAC T Rapid Assay, a device designed to detect troponin T in the bloodstream for the identification of myocardial damage. The ultra sensitive CARDIAC T Rapid Assay features a cutoff of 0.08 ng/mL, allowing physicians to detect even small amounts of troponin T for improved risk stratification of patients with chest pain.

Calypte Biomedical Corp., Berkeley, Ca, has completed the clinical trials regarding the use of a urine-based Western blot for HIV-1 antibodies. The Western blot is intended to be used as a specific, supplemental test on urines which are repeatedly reactive using Calypte's Urine HIV-1 EIA screening test.

Molecular Informatics Inc., Santa Fe, NM a developer of bioinformatics software, has signed a licensing agreement with Chiron Corporation MII's BioMerge bioinformatics software, that integrates genomic data from multiple sources.

Dade International, Deerfield, Ill, and Hoechst AG have signed an agreement for Dade to merge with Hoechst's Behring Diagnostics business unit. The resulting stand-alone company is to be named Dade Behring Inc. The merger is expected to be completed in the summer of 1997

Diagnostic Products Corporation, Los Angeles, CA has launched CAM 17.1 a screening test for pancreatic cancer. The company anticipates filing an application for domestic marketing clearance to the U.S. FDA in 1998.

FlexSure HP Whole Blood H. pylori test from SmithKline Diagnostics Inc., Palo Alto, CA is now waived under CLIA '88. The waived status expands the availability of the test to offices of primary care physicians who are certified to perform only waived tests.

LXN Corp., San Diego, CA, has received FDA clearance to market their blood glucose monitoring system that would allow diabetics to measure fructosamine levels at home. The fructosamine test is meant to be used every few weeks in conjunction with hemoglobin A1C and daily blood glucose tests.

HemaSure Inc. Marlborough, Mass, In-Line Diagnostics, Riverdale, Utah, and the American Red Cross have entered into a joint venture to develop a new, non-invasive anemia screening device based on In-Line's hematocrit technology.

Specialty Laboratories Inc., Santa Monica, CA, has developed the HIV-1 GenotypR PLUS blood test to detect resistance-associated HIV mutations for each of the FDA-approved antiviral drugs (nucleoside analogs and the new protease inhibitors, including Viracept). This test provides physicians the information they need to choose more effective drug cocktails for their HIV-positive patients. HIV-1 GenotypR PLUS uses PCR technology and automated DNA sequencing to identify specific HIV gene mutations in a patient's virus, and then matches them to known drug-resistant HIV viruses to identify similar resistance-associated mutations.

International Technidyne Corporation, Edison, NJ, was granted 501K marketing clearance by the US FDA for the home-use of the ProTime Microcoagulation System. ProTime can be used by patients on oral anticoagulant therapy to monitor the efficacy of their coumadin treatment.

Astra Merck Inc, Wayne, Pa,. has received US FDA approval to market the HpChek, a whole-blood, one-step single-use physician's office test to confirm the presence of H. pylori. The test was developed by ChemTrak Inc., Sunnyvale, CA, and will be marketed by Astra Merck as a companion product for Prilosec the company's prescription medication used for the treatment of several acid-related disorders, including active duodenal ulcer.

Meretek, Nashville, Tenn., has launched the MERETEK UBT Breath Test for H. pylori, a non-invasive, non-radioactive diagnostic to directly detect the presence or absence of active H. pylori infection. The test can be performed in the doctor's

office in about 30 minutes

International Murex Technologies, Toronto, ON has completed evaluation trials of a new HIV-1 Reverse Transcriptase (RT) monitoring test that simultaneously detects wild-type and HIV mutations associated with the drugs AZT, ddI, ddC and 3TC. Resistant mutations occur with all the approved HIV therapies. Therefore, it is critical to monitor the development of mutations so therapies can be appropriately combined and adjusted.

Sumitomo Metal Industries Ltd., Tokyo, and BML have jointly developed a testing kit for pancreatic cancer based on detection of mutated genes. The onset of pancreatic cancer is closely linked to a genetic mutation known as K-ras.

A team of investigators from Cal Tech, Dupont and Columbia University have developed a polymer that can be used to measure glucose concentrations in complex biological media. The metal-complexing polymer binds glucose and instantly

releases protons in proportion to the glucose concentration over a clinically relevant range.

Sanofi Diagnostics Pasteur has signed an agreement with the Beckman Instruments, Inc. involving the sale of assets linked to the automated ACCESS Immunoassay System and a long-term alliance in this area of business. The two partners have agreed to share development, production and marketing of the product.

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