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.

Calypte Biomedical Corporation has received FDA clearance to market the urine HIV-1 Western Blot test that confirms the presence of antibodies to HIV-1 in urine samples. The test is used on samples that are repeatedly reactive in the Calypte HIV-1 urine antibody screening test.

ChemTrak Inc. has signed an agreement with Pfizer Inc. to develop a disposable, quantitative, fingerstick whole blood test for one of Pfizer's drugs in development using ChemTrak's patented AccuMeter technology.

Digene Corporation is developing its Hybrid Capture II technology for DNA diagnostic testing, to improve detection, screening and monitoring of patients with HSV Types 1 and 2 infection. The total number of HSV tests performed annually is estimated to be 3-5 million in the U.S. and 6-10 million worldwide. Hybrid Capture tests for HPV, CMV, HIV, HBV, chlamydia and gonorrhea are already available.

Epitope, Inc. and STC Technologies, Inc., have received FDA clearance for the STC Opiates Metabolite Micro-Plate EIA Kit for use in detecting opiates and opiate metabolites in oral fluid collected with the OraSure/EpiScreen Oral Specimen Collection Device manufactured by Epitope. This assay joins other OraSure-based tests for cotinine, a metabolite of nicotine, and the NIDA-5 drugs, cocaine, methamphetamines, cannabinoids (THC), opiates, and phencyclidine (PCP).

Bayer Corp and Intelligent Medical Imaging Inc. have begun formal discussions regarding a possible licensing agreement for IMI's hematology slidemaker/stainer technology.

Medical Analysis Systems Inc. (MAS) has entered into an agreement in principle to acquire the assets of the TQC (controls) product line of Dade Behring. MAS has an exclusive agreement with CMS/Fisher HealthCare, a distributor of medical lab supplies and equipment. The Dade Behring TQC products are distributed through Allegiance Healthcare Corp., another distributor of medical equipment and supplies. MAS is not planning any changes in distributor relationships.

Medical Science Systems, Inc. is developing an osteoporosis genetic susceptibility test and analysis service. The company is gathering more clinical utility data for both the osteoporosis and coronary artery disease genetic susceptibility test products and expects to introduce one of those products upon completion of this phase within 12 months.

Morphometrix has developed 2 products for the automation of the Pap test. The first is an independent automated reader that analyzes Pap test specimens and can screen 40 specimens per hour. The second product is a monolayer preparation machine that prepares carefully controlled specimens in the laboratory.

American Biogenetic Sciences, Inc. has entered into an agreement with New Horizons Diagnostics Corporation to develop a point of care platform for the Thrombus Precursor Protein (TpP) and other tests. NHD has already produced a prototype of the test during a feasibility analysis. In addition, the agreement provides ABS with the right to distribute and sell NHD's other POC products. The test is expected to offer semi-quantitative results from a portable, user friendly, hand-held device in about five minutes. Further development of the POC test should be completed by the end of 1998.

Vysis, Inc. has developed the PathVysion HER-2 DNA Probe Kit, a diagnostic test to detect and quantify the HER-2 gene in breast cancer patients. An abnormally high level of the HER-2 gene has been associated with the rapid growth of tumor cells, resistance to therapy, shorter disease-free survival and poor prognosis for women with this disease. The test is based on Vysis' patented Fluorescence In Situ Hybridization (FISH) technology. Vysis is developing a completely automated instrument to process all the steps of its FISH-based assays.

Zeneca Diagnostics has launched its ELUCIGENE K-RAS7 test that detects gene abnormalities associated with bowel, pancreatic and lung cancers. ELUCIGENE K-RAS7, which uses Zeneca Diagnostics' proprietary ARMS (Amplification Refractory Mutation System) technology, detects seven frequently found mutations in the Kirsten ras oncogene. The test allows clinicians to detect low amounts of the mutated gene even when high levels of normal DNA from non-cancerous tissue are present. K-ras is believed to play an important role in up to 30% of human cancers where cells divide out of control. It is implicated in 25% of lung cancers, 50% of colon cancers and 90% of pancreatic cancers.

Product developments - May 1998
Product developments - Avril 1998
Product developments - March 1998
Product developments - February 1998
Product developments - January 1998
Product developments - July 1997
Product developments - June 1997
Product developments - May 1997
Product developments - April 1997
Product developments - March 1997
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