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.

The Edison BioTechnology Center (EBTC) has awarded $100,000 through its BioInvestment Fund to GyneConcepts, Cincinnati, OH, to develop an in-home pap smear test. GyneConcepts is collaborating with the Duke University BioMedical Engineering Department in research relating to its in-home Pap test.

Saliva Diagnostic Systems, Inc., Vancouver, Wash, has submitted a 510K pre-market notification to the U.S. F.D.A. for its Stat-Simple pylori device, a rapid whole blood test for H. Pylori. The product is currently available for sale in countries outside of the United States.

Epitope, Inc., Beaverton, Ore, and STC Technologies, Inc., Bethlehem, have received FDA clearance for the STC Cannabinoids Micro-Plate EIA for use in the qualitative determination of cannabinoids in oral fluid collected with the OraSure Oral Specimen Collection Device manufactured by Epitope, Inc. STC and Epitope continue to develop the full panel of products to allow drugs-of-abuse testing in oral fluids. Already being marketed are OraSure products to test for cocaine and methamphetamine using other STC EIAs.

A-Fem Medical, Portland, Ore, is developing The PadKit is designed to provide an alternative to the cervical scrape for collecting samples for cervical cancer screening and an alternative collection method to test for other cancers and diseases. The company also announced today that Phase I clinical studies for the PadKit will begin in early March, 1998. The PadKit is the first planned diagnostic application of the company's miniform, which is currently being sold as a new form of feminine protection under the brand "inSync". The PadKit contains a miniform for use as a collection device to collect a sample during the normal menstrual cycle. This sample may provide an alternative to the cervical scrape for cervical cancer screening and/or provide a sample to test for other conditions, including endometrial cancer.

Litmus Concepts, Inc., Santa Clara, CA, is developing four patented diagnostic tests that comprise the FemExam TestCard System. These tests, used primarily in the physician's office, screen and diagnose common vaginal infections such as bacterial vaginosis, yeast and trichomonasis. The tests are performed by collecting vaginal fluid with a cotton swab and wiping it across the reagent section of the FemExam card. While a typical vaginosis test performed at an outside laboratory costs about $25.00 to $30.00, the FemExam TestCards are expected to cost under $10.00.

Cardiovascular Diagnostics, Inc., Raleigh, NC is developing its Low Range Fibrinogen (LRF) Test, a point-of-care diagnostic for the measurement of fibrinogen concentration in patients treated with ancrod. The test is performed using CVDI's standard Thrombolytic Assessment System (TAS) analyzer.

Saf-T-Med, Inc., Barrington, Ill has received US FDA clearance to market its EasySafe syringe, a retractable-needle safety syringe which offers users 1) the ability to retract the needle inside the syringe after use to help protect against needlestick injury; 2) an interchangeable needle design, to maintain distribution efficiencies; 3) very low dead space, to save on wasted medication, and; 4) a needle guard which can be removed and re-secured with the hands entirely behind the needle.

First Medical, Inc., Mountain View, CA, has received US FDA clearance to market the Alpha Dx System, a panel of tests to aid in the diagnosis of acute myocardial infarction. The Alpha Dx System tracks cardiac marker measurements, creating individual patient profiles that provide a valuable diagnostic and prognostic tool for clinicians. Ultimately, the system will allow data integration with additional diagnostic information, such as the electrocardiogram, to provide further decision support for clinicians. The factory-calibrated system provides results in less than 20 minutes from whole blood or serum. The full cardiac panel includes CK, CK-MB, relative index, myoglobin and troponin I.

Trinity Biotech has launched its Uni-Gold one-step H. pylori test that uses one drop of whole blood, serum or plasma Uni-Gold H. pylori adds to Trinity's increasing range of one-step tests for the point-of-care including tests for hCG, HIV and Hepatitis B with tests for Strep A and Chlamydia to be released later in 1998.

Response Biomedical Corp., Vancouver, BC and Beacon Diagnostics, have signed a co-marketing, distribution and development agreement for non-invasive, diagnostic tests for five of Centocor, Inc.'s tumor markers. Beacon has a previous agreement with Centocor to develop these tumor markers for non-invasive cancer screening tests. Beacon will utilize Response's RAMP (Rapid Analyte Measurement Platform) technology to develop tumor markers in urine and saliva. The five tumor markers are: CA 19-9, CA 72-4, PSA, CA 15-3, and CA 125.

Technical Chemicals & Products, Inc., Pompano Beach, FL has signed an agreement with Boehringer Mannheim Corporation for more than $5 million a year of the Company's finished and packaged family planning products. These TCPI-manufactured products will be supplied directly to Boehringer Mannheim distributors.

Avitar, Inc., Canton, Mass, has begun selling its point-of-care oral fluids-based drug-of-abuse test for morphine/opiates/heroin to the corporate and forensic markets. Avitar is finalizing its preparation of a 510(k) submission to the FDA for sales to the clinical market.

Pacific Biometrics Inc., Irvine, CA, has submitted to the U.S. FDA a 510(k) pre-market notification filing for a test to measure an indicator of bone resorption using the company's proprietary SweatPatch system. Osteopatch is the first application of Pacific Biometrics' SweatPatch system. The Osteopatch system consists of a patented transdermal sweat collection device, proprietary assays for the detection of biochemical markers of bone loss in sweat, and a proprietary method for laboratory analysis.

Diametrics Medical, Inc., St. Paul, Minn, has filed a 510(k) application with the FDA for the Multi-use Cartridge (IRMA-M) for its IRMA SL Blood Analysis System. The IRMA SL Blood Analysis System is a handheld blood analyzer that performs tests such as blood gases, electrolytes and hematocrit using a single use disposable cartridge. The Multi-use Cartridge, IRMA-M, further enhances this system by allowing up to 50 separate test panels to be performed on a single cartridge before disposal.

LXN Corp., San Diego, CA has launched its patented Duet Glucose Control System that can perform both a blood glucose test as well as a self-test for GlucoProtein (fructosamine). This diabetes management system is now available for use both as an in-office test for healthcare professionals and as a self-test for persons with diabetes.

Shiloov Medical Technologies Ltd., Rehovot, Israel, has developed the HIV ShiloovTube, a blood pre-treatment device that improves the detection of HIV. The HIV ShiloovTube already has received regulatory approval in Mexico and is under regulatory review in Brazil, Israel, South Africa, Kenya and the U.S. Shiloov intends to market the HIV ShiloovTube to diagnostic laboratories, insurance companies, hospitals, clinics and blood banks, around the world.

Medical Science Systems Inc., Newport Beach, CA, now markets its PST, a genetic susceptibility test for periodontal disease.

Meridian Diagnostics, Inc., Cincinnati, Ohio, has launched three new, rapid, one-step tests for strep throat, infectious mononucleosis and pregnancy detection. ImmunoCard STAT! Strep A has received CLIA waived status.

Biosite Diagnostics Inc., San Diego, CA, has received U.S. FDA clearance to market the Triage Cardiac Panel for CK-MB, myoglobin and troponin I.

Beckman Instruments Inc. has introduced the new Synchron LX4201 Clinical System for high-volume laboratories. Among its many technological advances are fiber optic cabling, distributed processing using "smart" modules, clot detection, serum indices and advanced data management capabilities. The track-loading design is compatible with both robotic modular automation systems and conveyor-type total laboratory automation systems. Throughput is 2,880 tests per hour with an eight-second sampling cycle.

American Bio Medica Corp., Ancramdale, NY, has signed a three year agreement with Murex Diagnostics, for the distribution of its Rapid Drug Screen, an on-site substance abuse diagnostic test in the United States and Canada.

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Product developments - July 1997
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Product developments - June 1996