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.

Abbott Laboratories has received FDA clearance to market the first automated test to measure blood levels of homocysteine, which will run on the IMx system. The assay was developed by Axis Biochemicals ASA, of Oslo, Norway, and will be manufactured for Abbott.

AccuMed International has received FDA clearance for the TracCell 2000 Slide Mapping System for use with ThinPrep liquid-based preparations marketed by Cytyc Corp. This clearance is in addition to the FDA clearance on the TracCell 2000 received in August 1997 for use with conventional cervical Pap smears.

Avocet Medical Incorporated has received FDA clearance to market the AvocetPT a point-of-care prothrombin time (PT) meter, to the health care professional market. The AvocetPT procedure is a quick, three-step process -- turn the meter on, insert a test strip apply a single drop of blood, and you have a result in less than 4 minutes. The AvocetPT System includes a meter, test strips, liquid controls and an Electronic Control.

Biosite Diagnostics Incorporated has received FDA clearance to market the Triage Parasite Panel, which will be distributed in the US by Fisher Healthcare. The Triage Parasite Panel detects Giardia lamblia, Cryptosporidium parvum and Entamoeba histolytica/dispar in approximately 20 minutes. The qualitative visual test is performed on a compact, disposable device that is approximately the size of a credit card. Using a stool sample, a laboratory clinician completes a simple multi-step process to obtain simultaneous discrete test results for the three parasites, with a color bar indicating the presence of targeted pathogens.

ChromaVision Medical Systems Inc. has entered into an agreement with DAKO Corp. to co-market the ChromaVision Automated Cellular Imaging System (ACIS) in combination with DAKO's HercepTest kit in the United States as an integrated HER2 protein expression system for the guidance of breast cancer therapy. Market availability for the system is anticipated in the first quarter of 1999.

Digene Corporation has received FDA clearance to market its Hybrid Capture CMV DNA Test in the United States. Digene's Hybrid Capture CMV DNA Test detects CMV infection in solid organ transplant, bone marrow transplant and HIV-positive/AIDS patients.

Lifestream Technologies has received FDA clearance to market the Cholestron Pro, a hand-held instrument that measures total cholesterol levels. Requiring just one drop of blood and costing the patient less than $10 per test, the Cholestron Pro measures total cholesterol level in about three minutes, without patient fasting. The Cholestron Pro is used in conjunction with a patented disposable test strip developed in collaboration with Roche Boehringer Mannheim. In addition to measuring cholesterol, the Cholestron Pro also considers seven other risk factors for developing coronary heart disease: body mass index (BMI), family health history, smoking habits, diabetes status, gender, age and blood pressure to determine the patient's biological age, or heart health, compared to other people of his/her calendar age.

Phamatech has received FDA clearance to market its QuickScreen At Home Drug Test, the first-ever over-the-counter test for drugs of abuse. The test can be performed at home and gives results in approximately 10 minutes. QuickScreen comes in two models: one tests for cocaine, marijuana, opiates, amphetamine and phencyclidine (PCP); the other tests for cocaine, marijuana, opiates, amphetamine and methamphetamine. The QuickScreen At Home Drug Test will be available Dec. 1, 1998, and will sell for under $30. The QuickScreen At Home Drug Test kit consists of a urine- collection cup and test device containing antibodies against specific drugs. The test device is placed in the urine sample after it is collected.

Healthcare Technologies' subsidiary, Savyon Diagnostics, has received FDA approval for its urinary tract infection product, Uriscreen, for over the counter usage. Savyon is negotiating with major pharmaceutical corporations regarding distribution of the product across North America. Uriscreen measures catalase, an indicator of both bacteria and/or white blood cells, the key indicators of a UTI, and has a 91% level of accuracy when compared to a reference culture, or actual bacteria measure method. UTI tests currently on the market test for nitrate and are far less accurate than Uriscreen.

Technical Chemicals & Products, has received FDA clearance to market its Uri-Test Protein in Urine Test home screening test for protein in urine, which may be an early warning indicator of injury or disease of the kidney, bladder or renal system as well as complications of diabetes mellitus. This product will be added to the Company's HealthCheck brand of at home diagnostic testing and screening products and marketed under the name Protein in Urine Screening Test. This new screening test is expected to be available for shipping in late 1998 or early 1999 - it will have a suggested retail price of $9.99 and contain three screening tests per box.

Trinity Biotech makes three major announcements in October:

Trinity has entered into an agreement with Strategic Diagnostics, Inc. to acquire an assay that measures Lipoprotein Lp(a), a predictor of premature atherosclerosis and coronary heart disease. The Lp(a) test, called Macra Lp(a), is the only Lp(a) method cleared by the FDA for both diagnosis and risk assessment of coronary heart disease. The transaction includes both the ELISA assay and the antibody cell cultures for the manufacture of base antibody. Trinity intends to sell Macra Lp(a) in the U.S. through its marketing partner, Wampole Laboratories, a division of Carter Wallace

Trinity has signed an agreement to purchase the Microtrak product line from the Syva Company, a subsidiary of Dade Behring, Inc. for $10.2 million in cash and loan notes. The tests will be distributed in the U.S. through the Wampole Laboratories division of Carter Wallace and by Dade Behring in Europe, Asia, Canada, Africa, and Latin America.

Trinity has acquired the infectious disease diagnostics business of Cambridge Diagnostics Ireland Ltd., a subsidiary of Selfcare, Inc. of Waltham, MA for a consideration of 555,731 shares of Selfcare, Inc. common stock owned by Trinity Biotech, and $280,000 in cash. The products include three tests for the diagnosis of HIV antibodies. Capillus HIV 1/2 and RTD HIV 1/2 are rapid tests that detect HIV antibodies in whole blood, serum or plasma. The third product (Recombigen) is a microtitre plate assay, which is used for diagnosis of HIV in clinical and reference laboratories, and is also used in blood banks for screening of blood donations.

Trinity Biotech it has sold its U.S. OTC pregnancy business to Applied Biotech Inc., a subsidiary of Sybron International Corporation, for $3 million in cash. Trinity may receive further payments of up to $750,000 depending on the achievement of certain agreed milestones. Trinity will continue to actively market its Uni-Gold midstream and cassette pregnancy tests in the U.S. professional market and in the OTC and professional market segments throughout the rest of the world.

Product developments - September 1998
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Product developments - June 1996