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.

AcroMetrix has introduced the a HCV nucleic acid quantification panel calibrated to the World Health Organization (WHO) International Standard. Because laboratories worldwide utilize numerous testing methods, each having a different standard of measurement for the amount of virus in the patient's blood, the potential exists for misinterpretation of patient results. The AcroMetrix panel was designed to insure a consistent standard across all test methods and that will also provide an independent standard for the validation of new systems and techniques on any HCV nucleic acid procedure.

Ambion, Inc. has been awarded a phase II SBIR grant for $808,000 from the National Institute of Allergy and Infectious Diseases (NIAID) to further the development of their Armored RNA technology for the manufacture of stable, robust RNA that can be used as controls or standards in viral diagnostic kits such as HIV and HCV. The Armored RNA technology was developed jointly with Cenetron Diagnostics. To date, Roche Diagnostic Systems, Innogenetics and Gen-Probe (San Diego, CA) have obtained non-exclusive licenses to use Armored RNA as controls and standards for diagnostic applications.

AXONYX Inc. has entered into a joint development agreement with the Department of Pathology at the University of Melbourne in Australia to develop a diagnostic test for Alzheimer's Disease that involves a fingerprint-type analysis of certain markers including an abnormal form of acetylcholinesterase. The test is expected to discriminate Alzheimer's Disease from other dementias.

AutoCyte has completed its merger with NeoPath and the new company is named TriPath Imaging, Inc. The initial primary product platforms will consist of the AutoCyte PREP System for thin-layer sample preparations, and the AutoPap Primary Screening System for computerized image analysis of conventional Pap smears. TriPath will be submitting to the FDA a PMA supplement requesting approval to screen PREP slides on the AutoPap to provide an automated cervical cancer screening product. TriPath recently acquired Cell Analysis Systems, Inc., a subsidiary of Becton Dickinson and Company that offers computerized microscopic image analysis systems with a wide range of research oriented applications including DNA measurement and specific cell marker quantification. BD remains responsible for the support of the current installed base of CAS instruments. TriPath has already developed a general-purpose image analysis system and currently offers a state-of-the-art replacement for CAS systems.

Avitar, Inc. is forming a new subsidiary to exploit the oral fluids collection and processing technology which Avitar has developed and commercialized for the drugs of abuse market, for disease diagnostic testing which is yet to be decided.

Bio-logic Systems Corp. has been awarded a National Institute of Health a $100,000 grant to implement a six-month study measuring the feasibility of using Auditory Brainstem Response (ABR) technology for the detection of acoustic tumors. Accurate and early detection of very small acoustic tumors, less than one centimeter, is difficult with standard Auditory Brainstem Response (ABR) technology. As a result, enhanced MRI is now being used as the initial screening device for patients suspected of having this type of tumor. Testing performed with this advanced ABR system should help reduce the number of non-tumor patients being sent for MRIs.

Genome Therapeutics Corp. and bioMerieux Diagnostics have formed a strategic alliance to develop in vitro diagnostic products for human clinical and industrial applications. As part of the alliance, bioMerieux has purchased a subscription to Genome Therapeutics' proprietary microbial database PathoGenome and made an equity investment in Genome Therapeutics. bioMerieux has initiated Anais, a research program to develop a fully automated, microchip-based molecular diagnostic system that will enable more rapid identification of infectious diseases, especially those caused by drug-resistant organisms. bioMerieux will incorporate Genome Therapeutics' genetic information into its Anais system using the GeneChip Array technology from Affymetrix.

BioSafe Diagnostic Products has introduced a new HbA1c home test kit that enables patients to collect their own blood sample for lab analysis and physician interpretation. The BioSafe HbA1c test uses a proprietary method of re-hydrating dried blood samples that produces readings as accurate as tests conducted with liquid samples. The new test kit is available by prescription only and will be available at pharmacies in the US. After putting three drops of blood on a collection card, the patient mails the card in a postage-paid envelope to BioSafe's laboratory for analysis. The test kit's price is $49.95 and is covered by most insurance plans under C.P.T. Code #83036.

Biosite Diagnostics has formed a Biosite Discovery initiative aimed at identifying diagnostic markers for stroke. Biosite is conducting internal evaluations of existing stroke markers, using the Biosite Discovery Omniclonal antibody technology as well as investigating collaborative research agreements with genomics and proteomics companies.

Carmel Biosensors Ltd., is collaborating with Medtronic, Inc., for research and development of advanced biosensors for various medical applications. Financial and other terms of the agreement were not disclosed. The biosensors will be based on a combination of living cells and microelectronics, which will be used for continuous monitoring of glucose, hormone levels, anesthetic agents and other factors within the human body such as Oxygen, CO2 and drugs. The first sensor product in development, is a bio-electronic device which can continuously monitor diabetics' glucose levels within the human body.

CAS Medical Systems., Inc. has purchased the Corometrics Event-Link Monitoring System from GE Marquette Medical Systems. The sale includes the complete product line of infant and adult apnea monitors and accessories for hospital and home use as well as the Event-Link Software for data retrieval and display. The Event-Link Monitoring System provides accurate, reliable heart rate and respiration monitoring. The newest Event-Link monitors meet the current FDA guidelines for home monitors and combine cardio-respiratory monitoring, pulse oximetry and event recording into a single device.

Cardiovascular Diagnostics, Inc. has filed a 510(k) submission with the FDA for its Heparin Management Panel (HMP) and Accent system. This system combines Thrombolytic Assessment System (TAS) technology and the currently marketed Heparin Management Test (HMT) with two new test cards, the Heparin Titration Test (HTT) and Protamine Response Test (PRT), along with the Accent, a hardware accessory to the TAS analyzer. The TAS is currently marketed as the Rapidpoint Coag by Bayer Diagnostics. These products are used to facilitate anticoagulation management during cardiopulmonary bypass procedures.

Coastal Medical Services has received FDA clearance to market its OTC, MCC RapidScreen Home Test Kit for drug screening in the home.
It will test for Cocaine, Marijuana, Methamphetamine, PCP and Morphine. It works similarly to home pregnancy test kits currently sold over the counter. The five panel card is dipped into a urine sample for 30 seconds.

Cytogen Corporation intends to acquire an exclusive, worldwide license from Molecular Staging, for their Rolling Circle Amplification Technology (RCAT) to develop in vitro diagnostic tests for Prostate Specific Membrane Antigen (PSMA) and Prostate Specific Antigen (PSA). A sensitive test for PSMA, either alone or in combination with PSA, may enable physicians to better identify men who are more likely to truly harbor prostate cancer and need additional diagnostic work-up. The assays for clinical study should be available by mid-year 2000.

Dade Behring Inc. announced has received clearance from the U.S. FDA to market the BFT II hemostasis analyzer to clinical laboratories in the United States. The dual-channel BFT II analyzer is a small portable system for routine coagulation tests. The analyzer is most suited for low-volume testing in small laboratories, or as a back-up to a larger hemostasis analyzer. Dade Behring recently acquired an interest in HemoSense, Inc., to provide point-of-care hemostasis systems for use in the home and physician offices.

Diagnostic Systems Laboratories Inc., has received exclusive distribution rights from Oxford Bio-Innovation Ltd. for the sale and manufacture of Inhibin-A assay kits. Inhibins are hormones that suppress the secretion of FSH from the pituitary.

Epitope, Inc. has received a $1.1 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant to develop a test for syphilis using either blood or oral fluid samples. Epitope will modify its patented OraSure oral fluid collection device to provide the oral fluid sample for this test. The entire project is expected to last approximately 18 months.

Hycor Biomedical Inc. has sold its ESR product line, including the rights to three patents on its Erythrocyte Sedimentation Rate Control that it received in 1999 to Streck Laboratories, Inc. and Hematronix, Inc. Hycor has decided to focus its core business on allergy, autoimmune and urinalysis, and to divest its hematology product lines.

Immunetics, Inc. has received FDA clearance to market its QualiCode Borrelia burgdorferi IgG and IgM Western Blot Kits. According to the protocol recommended by the Centers for Disease Control, all patient sera which test positive or indeterminate on an ELISA screening assay must be re-tested by Western Blot.

Johnson & Johnson has acquired Centocor, Inc. in a stock-for-stock exchange with a value of $4.9 billion.

Lifestream Technologies has begun pre-market clinical trials for its consumer cholesterol systems in preparation of an OTC, 510[k] Pre-Market Notification. The Lifestream cholesterol test is an instrument- based, quantitative consumer-use system that features the use of a smart card for test result storage and data transmission using Lifestream's Privalink internet system. Lifestream expects the tests to be priced at approximately $3.00.

LXN Corporation has received FDA clearance to market its rapid result glucose monitor. LXN is currently in discussion with several diabetes supply companies regarding the distribution of its rapid result monitor and is seeking additional distribution partners for both the U.S. and international markets. LXN recently introduced the In Charge Diabetes Control System, a consumer version of its successful Duet Diabetes Control System, both of which combine a fructosamine and glucose test in one monitor.

Matritech has entered into a collaboration with the Johns Hopkins University School of Medicine, to develop a new prostate cancer test that will measure YL-1, a nuclear matrix protein, that has the potential to differentiate between aggressive and low-grade disease.

Metrika Inc. has received FDA clearance to market its DRx Quantitative hCG patient monitor, a single-use, physician office test. Metrika will manufacture the system and is currently seeking a partner to provide exclusive marketing and distribution for the product. Metrika's DRx Quantitative hCG device utilizes Metrika's patented DRx patient monitoring system, integrating miniaturized digital electronics, micro-optics and dry reagent chemistries into a hand-held, one-step monitoring instrument. The DRx patient monitor is especially designed to allow both immuno diagnostic and general chemistry analyses to be performed simultaneously from a single, unprocessed blood or urine sample.

OrSense Ltd. is developing non-invasive monitors of blood analytes using an optical method of measurement in the NIR range of hemoglobin/hematocrit and glucose. A clinical prototype for hemoglobin is currently in clinical trials and the company is seeking strategic partners to commercialize the device. Future products in the OrSense pipeline include non-invasive monitors for cholesterol, triglycerides, and albumin.

Ostex International, Inc. has received FDA clearance for its Osteomark NTx Point-Of-Care device for testing in the physician's office. In addition, Ostex has signed an agreement with PSS World Medical, Inc. as its exclusive U.S. distribution partner for the NTx Point-Of-Care device.

Quidel Corporation has received FDA clearance to market its QuickVue Influenza Test, a rapid, point-of-care diagnostic test to detect influenza A and B. The influenza diagnostic was developed through a product development collaboration with Glaxo Wellcome, plc.

Sulzer Medica has begun clinical trials of the INRange Monitored Heart Valve System that includes the Carbomedics Prosthetic Heart Valve plus a portable device for measuring and monitoring a patient's prothrombin time, as well as the Raytel Cardiac Services, a telephone monitoring service. With the INRange system the patient can regularly measure the effects of the prescribed anticoagulation at home in a similar manner to the way in which a diabetic patient measures blood sugar.

Sybron International Corporation has purchased Microm Laborgerate GmbH, a manufacturer of histology laboratory instrumentation headquartered in Walldorf, Germany. Microm's products include microtome and cryostat machines used in tissue sectioning, as well as automatic slide stainers, tissue processors, cover slippers and cassettes used in routine histology and cytology applications. Sales revenues are approximately $22 million.

Technical Chemicals and Products, Inc. has submitted a 510(k) application for over-the-counter FDA marketing clearance for its HealthCheck Total Cholesterol Home Screening Test. The Total and HDL Cholesterol Home Screening Tests use the company's patented membrane-based technology. The test strip changes color in proportion to the amount of total or HDL cholesterol present. This color change allows the user to visually compare the test strip to a standardized color chart, and to determine the appropriate total or HDL cholesterol medical risk group.,

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