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.

Accumetrics, Inc. has received FDA clearance to market its POC Ultegra System to measure platelet function in patients undergoing coronary interventional procedures. The Ultegra System, which consists of an instrument and single-use disposable cartridges, provides an assay result in less than two minutes using a sample of whole blood. The blood sample is drawn using a standard blood tube which is then inserted into the test cartridge in the instrument.

American Bio Medica Corp. has acquired the exclusive rights for distribution and marketing of DRUG DETECTOR from Mistral Security, Inc., in North and South America. A patented on-site drug detection system, DRUG DETECTOR tests for the presence or absence of residue from marijuana, cocaine, heroin or methamphetamines without the need for urine, hair or saliva samples. The product comes with a special pad and aerosol spray, which are utilized to perform the test. The pad is used to wipe a surface and then the spray is applied to the pad; a specific color change on the pad indicates the presence of the drug residue. American Bio expects to have the product, which does not require FDA clearance, on shelves in retail stores across the US by spring 2000.

Ampersand Medical Corporation has developed a new approach to automated PAP testing. Protein-based biomolecular markers are the central component of the new InPath System for cervical cell collection and analysis system. The system uses a proprietary cell collection device that improves sampling by gathering cells from the complete cervix, versus only random areas sampled with the current brush/spatula method.

bioMérieux has introduced a new, rapid, confirmatory test for ESBL enzymes, a resistance mechanism associated with serious infections.
ESBL producing strains of bacteria are appearing with increasing frequency in U.S. health care institutions. The new assay became available in December 1999 on two new gram negative cards for the VITEK System.

Biopool International Inc. has filed an FDA 510(k) pre-market notification for its MiniQuant D-dimer test system, a rapid, quantitative method for determining the fibrin degradation product D-dimer in plasma. The assay is performed using Biopool's MiniQuant latex agglutination reagent and the MiniQuant-1, a compact two-channel LED photo-optical detection system for use in laboratory and emergency care environments.

Calypte Biomedical Corp. has launched Sentinel, a urine-based testing service for HIV-1 antibody, chlamydia and gonorrhea in collaboration with Wampole Labs, with a unit of Carter Wallace Inc. The Sentinel service targets a three-day response and will be available exclusively to medical clinics and physicians beginning in the second quarter of 2000.

Careside Inc. has received FDA clearance to market its CARESIDE Direct Bilirubin blood test. This test clearance brings the current number of cleared or exempt tests on the CARESIDE Analyzer to 37. The company has reported that it will continue to add other chemistry tests as well as coagulation tests to the menu.

Cholestech Corp., marketer of the POC Cholestech L.D.X System for glucose and lipids has acquired Health Net, Inc. a healthcare wellness testing company that specializes in providing cholesterol, lipid, glucose, hemoglobin A1c and osteoporosis testing to consumers. Health Net administers consumer wellness testing programs in venues across the United States.

Cardiovascular Diagnostics has received FDA clearance to market its Heparin Management Panel and Accent system, that combines Thrombolytic Assessment System (TAS) technology and the currently marketed Heparin Management Test with two new test cards - the Heparin Titration Test and the Protamine Response Test along with the Accent, a microprocessor-based device that automatically calculates the information required by physicians to manage the anticoagulation of patients during cardiopulmonary bypass procedures. The system will be marketed by Bayer Diagnostics as Rapidpoint ACCENT with a launch anticipated in Q2 2000.

Diagnostic Products Corporation has entered into an exclusive U.S. sales and marketing alliance with Dade Behring, Inc. for Novation customers that covers the Immulite portfolio of immunochemistry diagnostic systems and tests. Dade Behring has been awarded an immunochemistry contract to 2,000 healthcare organizations that purchase supplies through Novation, the supply company for VHA Inc. and the University HealthSystem Consortium, two national health care alliances.

e-UMEDIK Inc. is developing e-UMEDIK DIA/PRO System, a biomedical product, is a proprietary platform technology, designed to provide immunodiagnostic results in several main fields of application, including point-of-care, medical, veterinary, pathogen detection, home care and over the counter testing. The hand held reader may directly interact with a patient's database to provide a test result dependent mode of action for the physician and the patient.

InteCardia, Inc., a cardiology services company, and LipoMed, Inc. will co-promote LipoMed's new NMR LipoProfile blood test. The NMR LipoProfile simultaneously analyzes more than 15 different subclasses of lipoproteins.

Nymox Pharmaceutical Corporation will acquire majority ownership of Serex, Inc. in a share exchange agreement. Serex has developed the Serex LabTab system used in rapid testing of blood, urine and saliva samples in laboratories, hospitals, doctors' offices or homes. Serex has recently developed and started to commercialize the NicoMeter urine and saliva tests that measure tobacco use or exposure.

Polymer Technology Systems has received FDA clearance to market the blood ketone test on the company's BioScanner 2000 analyzer, designed for both home and physician office use. This brings the number of tests available for the BioScanner 2000 in the over-the-counter market to three including glucose and total cholesterol.

StressGen Biotechnologies Corp. has introduced its EIA kit for the measurement of heat shock protein 70 (Hsp70) in a variety of species and sample types. The kit includes all components required to detect Hsp70 in samples in under 4.5 hours. It is currently available for $650.00 US. The production of Hsp70 is increased in response to exposure to stress such as hypothermia, hypertension, toxic exposure to chemical agents, hypoxia, ischemia, inflammation, autoimmunity, apoptosis, cancer, organ transplantation, bacterial and viral infections.

TheraSense, Inc. has received FDA clearance to market its FreeStyle glucose monitor which will allow people with diabetes to obtain a blood sample from places other than fingertips. FreeStyle provides a blood glucose value using a fraction of the blood sample currently required by other products on the market. This smaller blood sample gives people the freedom to test on sites other than their fingertips.

Ventana Medical Systems, Inc. has submitted a PMA to the FDA for its CB11 antibody that physicians could use in deciding whether metastatic breast cancer patients should receive Herceptin used in cancer patients that test positive for Her-2/neu receptor overexpression.

Product developments - December 1999
Product developments - November 1999
Product developments - October 1999
Product developments - September 1999
Product developments - August 1999
Product developments - July 1999
Product developments - June 1999
Product developments - May 1999
Product developments - April 1999
Product developments - March 1999
Product developments - Febuary 1999
Product developments - January 1999
Product developments - December 1998
Product developments - November 1998
Product developments - October 1998
Product developments - September 1998
Product developments - August 1998
Product developments - July 1998
Product developments - June 1998
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