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.

Shield Diagnostics Plc, Scotland has signed a licensing agreement with Abbott Laboratories for a new test to predict heart attack risk. Under the deal, Abbott will add a test for Shield's blood clotting agent Activated Factor XII to its IMx immunoassay system. The agreement also gives Abbott rights to distribution of the IMx AFT assay and for future development of AFT assays on other Abbott instruments. Shield believes AFT is a much more accurate predictor of heart attacks than cholesterol.,

AccuMed International, Chicago, IL has received FDA clearance to market its Sensititre Gram Positive Identification Panel for use in conjunction with the Sensititre Microbiology System for the automated identification of clinically significant Gram positive bacteria. The Sensititre AP90 Auto Identification plate is an in vitro diagnostic product that utilizes fluorescence technology to detect bacterial growth or metabolic activity. The Sensititre AP90 Auto Identification Database was developed by testing 762 strains of clinically relevant Gram positive organisms, which include bacteria that are of increasing significance for their resistance to standard antibiotic therapy.

Progenitor, Inc., Menlo Park, CA has formed a research collaboration with Affymetrix, Inc. to identify genetic polymorphisms associated with asthma. The collaboration will include development of custom Affymetrix GeneChip DNA probe arrays to identify variations in asthma patients' DNA, and testing of those variations for correlations with asthma and inflammation.

AVL Medical Instruments and Boehringer Mannheim Corp. have signed a co-operation and alliance agreement for research and development, manufacturing and co-marketing of products, information solutions and services dedicated to the Hospital Point-of-Care market place. AVL currently markets the OMNI line of analyzers for high volume critical care testing, the Compact line for smaller volumes and the OPTI line for single use Point-of-Care testing. AVL and Boehringer Mannheim anticipate that their first joint product will be presented late in 1998. Moreover, the companies will pool dedicated marketing and sales forces in selected markets to address this opportunity.

Biocircuits Corp., Sunnyvale, CA has developed a Free T4 test cartridge for use in the IOS immunoassay system. Currently four cartridges are available for use on the system, a T4/T Uptake combination, TSH, T4/TSH combination and a Quantitative hCG cartridge. In addition to the Free T4 cartridge, a Digoxin cartridge is also in clinical evaluation and a PSA test is in late development stages.

Biomerica, Inc., Newport Beach, CA will introduce a new diagnostic test for detecting autoantibodies to Glutamic Acid Decarboxylase (GAD), an early warning indicator of type I diabetes. The new GAD test will be first marketed outside the United States and later will be sold in the U.S. after receiving FDA clearance. The product is a part of Biomerica's diabetes product line which includes tests for detecting diabetic predisposition. The product, which will be marketed under the trade-name, Isletest-GAD and may be performed at almost all clinical laboratories using common laboratory equipment.

Biosite Diagnostics, San Diego, CA has completed all 510(k) pre-market notification filings for a new rapid test designed to identify Clostridium difficile. The Triage C. diff Panel is the first in a family of infectious disease products to be developed by Biosite.

BioStar, Inc., Boulder, CA has begun clinical trials of a new rapid test for the detection of influenza. The 15-minute assay will detect both influenza A and influenza B using BioStar's proprietary Optical ImmunoAssay (OIA) technology.

Oncor Inc., Gaithersburg, GA, has received FDA market clearance for the Oncor INFORM HER-2/neu breast cancer test. This is the first time the FDA has approved a gene-based test for prediction of cancer recurrence. Using original breast cancer tissue sample, the Oncor INFORM HER-2/neu test identifies the presence or absence of increased copies of the HER-2/neu gene. This indicates whether or not breast cancer is likely to return. In clinical trials, 31 percent of patients with originally localized breast cancer that had a positive HER-2/neu test died within five years of surgery, while 97 percent of patients with negative test results survived at least five years. Conventional detection procedures must wait until the disease recurrence is present, allowing the cancer to advance before treatment begins.

Oncor and its partner Geron Corp. have launched a high through-put assay to detect levels of telomerase. The TRAPEZE ELISA Telomerase Detection Kit, offers a versatile, non-isotopic format to perform this assay.

Dade Behring Inc. has signed a worldwide sublicensing agreement with Abbott Laboratories for the right to develop, manufacture and sell diagnostic tests to detect and monitor the level of FK506 (tacrolimus), a immunosuppressive drug, in transplant patients.

Diametrics Medical, St. Paul, Minn., has received FDA clearance to market its Neotrend product, a system for direct continuous monitoring of blood gases (oxygen, carbon dioxide and acidity) and temperature in critically ill premature babies. The Neotrend System uses a tiny fiber optic sensor (.5mm in diameter) and a monitor to continuously measure blood gases and temperature. The sensor is inserted through an Umbilical Artery Catheter into the infant's descending Aorta, so it is unaffected by changes in peripheral circulation which impact existing monitoring technology. The system also includes a detachable Patient Data Module for storing patient data if the patient requires moving to an alternative treatment site.

Epitope, Inc., Beaverton, OR and STC Technologies, Inc., Bethlehem, PA, have received FDA clearance for the STC Cocaine Metabolite Micro-Plate EIA Kit for use in detecting cocaine and cocaine metabolites in oral fluid collected with the OraSure/EpiScreen Oral Specimen Collection Device manufactured by Epitope. This is the first oral fluid-based immunoassay for drugs of abuse cleared by the FDA. Under an agreement with Epitope, STC has developed OraSure-based tests for cotinine, a metabolite of nicotine, and a group of drugs commonly called the NIDA-5. The NIDA-5 include cocaine, methamphetamines, cannabinoids (THC), opiates, and phencyclidine (PCP). Four oral fluid 510(k) submissions for cocaine, methamphetamine, THC and cotinine have been submitted to the FDA. Two additional 510(k) submissions for oral fluid opiates and PCP are expected during the first quarter of 1998.

First Medical, Inc., Mountain View, CA has filed a 510(k) notification with the US FDA seeking clearance to market the Alpha Dx System, a clinical decision support system using whole blood for the rapid, quantitative and simultaneous measurement of a panel of tests (myoglobin, CK, CK-MB, relative index and troponin I) to aid in the diagnosis of acute myocardial infarction. The Alpha Dx System consists of a factory calibrated tabletop analyzer and Cardiac Panel Test Kits, which include single use test discs containing reagents and bilevel controls needed to perform test panels. The system uses whole blood or serum and provides results in less than 20 minutes. It has the accuracy and precision for use in the clinical laboratory but is easy enough to be used in the emergency department, chest pain center or cardiac care unit. The Alpha Dx System will track and display serial results from individual patients to assist physicians in interpreting multiple cardiac marker measurements made over several time points. The system will ultimately allow the integration of other diagnostic information such as the ECG and other clinical data to provide enhanced decision support for clinicians.

Gull Laboratories, Inc. has received a worldwide exclusive license from Parteurop Developpement, Lyon, France, for the use of the patented p130 synthetic peptide in products to be developed, manufactured and distributed by Gull for the diagnosis of infection with Epstein-Barr virus (EBV). The p130 peptide will provide diagnostic tests which have higher sensitivity and specificity than any existing commercial test for early infection with EBV. These new tests will complement Gull's current EBV diagnostic test panel.

Meridian Diagnostics, Inc., Cincinnati, Ohio, has submitted to the FDA, its Premier Platinum HpSA, a noninvasive patent pending test for the detection of H. pylori antigens, for marketing clearance. The test is performed on a stool specimen and requires about one hour for final results.

Metra Biosystems, Mountain View, CA has acquired worldwide rights to the technology for its Chondrex immunoassay from NovaDx International Inc. including all available sub-licensing rights. Metra has also obtained rights to diagnostic applications of NovaDx's proteomics-based technology, and products for osteoporosis and arthritis. Metra has agreed to make an equity investment in NovaDx at a premium to NovaDx's market price. NovaDx will receive certain up front and milestone payments, and in addition will receive royalties and sub-licensing fees.

International Murex Technologies Corporation, Toronto, ON has received 51OK clearance from the FDA to market a new, combination E. coli O157:H7 assay. The test uses latex agglutination technology for the identification of E. coli O157 and the flagella antigen H7. The 30-second test, developed by Murex's internal research and development, is simple-to-use and produces highly accurate results.

Myriad Genetics, Inc., Salt Lake City, has launched a genetic test, CardiaRisk, to be performed by its Myriad Genetic Laboratories subsidiary. The test, which identifies a mutation in the AGT gene, will assist physicians both in identifying which hypertensive patients are at a significantly increased risk of developing cardiovascular disease, and identifying which patients are likely to respond to low salt diet therapy and antihypertensive drug therapy. CardiaRisk is the second genetic test developed and made available to the medical community by Myriad in the past fifteen months. The test takes approximately 2 weeks to perform and is priced at $395.

NeoPath Inc., Redmond, Wash, has received FDA market clearance for use of the AutoPap System as a Primary Pap smear Screener. The AutoPap System is the first device of its kind to receive a Panel approval recommendation for use in automated initial Pap smear screening. The AutoPap System utilizes proprietary visual intelligence technology to identify those Pap smears with the highest potential for abnormality.

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 blood banks, hospitals, clinics and diagnostic laboratories around the world. In addition, the company plans to accelerate its development of a new product for the early detection of the virus that causes Hepatitis C.

SpectRx, Inc., San Francisco, CA has entered into exclusive agreements with three leading neonatal product marketing companies to market its BiliCheck, Non-invasive Bilirubin Analyzer in Germany, The United Kingdom, Switzerland, Austria, Sweden and Argentina. The company also announced that it plans to begin shipping the BiliCheck and associated single-patient-use disposables to Europe and South America in the first quarter of 1998. Healthdyne Technologies holds U.S. marketing rights to the BiliCheck and is conducting U.S. clinical trials prior to submission to the FDA for 510(k) clearance. The BiliCheck is a hand held, painless, non-invasive bilirubin analyzer designed to replace the heel stick blood test. The BiliCheck uses light to measure bilirubin levels in newborn patients without a blood sample, regardless of skin color, gestational age or post-natal age.

Trinity Biotech, Dublin, Ireland has received FDA clearance to market its Adenovirus test kit, an EIA in microtitre plate format, which detects the presence of the Adenovirus in stool samples. The product will be distributed in the U.S. by Wampole Laboratories, a division of Carter Wallace, Inc. Trinity currently sells two other FDA approved kits to the U.S. market and is developing tests for Cryptosporidium, Giardia and E. Histolytica. Trinity also has a C. difficile kit currently being marketed in Europe and plans to file an FDA submission during the first quarter 1998.

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