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.
AMDL, Inc., Tustin, CA has filed a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for PyloriProbe(TM), a direct enzyme immunoassay (EIA) that will detect the presence of H. pylori antibodies in blood serum samples.
AXCAN PHARMA, Montreal, has signed an agreement with Astra Pharma Inc., the Canadian subsidiary of Astra AB of Sweden, to distribute samples of HELISAL(TM) physicians in Canada. The HELISAL(TM) Whole Blood Rapid Blood Test to detect the presence of Helicobacter pylori bacteria. The test, developed by Cortecs International Ltd, can be performed in a physician's office and allows for immediate diagnosis of H. pylori infection.
The US FDA has approved for market the BECKMAN Instruments FlexSure Hp, a single unit whole blood test for the detection of IgG antibodies to H. pylori. The point-of-care tests is sold through SmithKline Diagnostics, Inc. a wholly owned subsidiary of Beckman Instruments, Inc. The H. pylori product line is also distributed through an alliance with Abbott Laboratories.
BIOPOOL International has received FDA approval to use a synthetic urine base for its Sure accuracy drug test. The synthetic urine base will reduce the risk of exposure for technicians performing the test to infectious diseases present in human urine. The company has also received U.S. FDA approval to market the company's new TintElize PAI-1 Assay Kit, which measures the level of plasminogen activator inhibitor-1 (PAI-1) in blood. Plasminogen activator inhibitor-1 (PAI-1) is a naturally occurring protein in the blood that is a fast-acting inhibitor of tissue plasminogen activator, and PAI-1 activity is one of the most important proteins regulating fibrinolysis (the body's ability to break down blood clots). Numerous clinical studies have demonstrated that defective fibrinolysis is closely associated with the incidence of coronary heart disease, including angina pectoris, myocardial infarction and primary cardiac arrest.
BOEHRINGER MANNHEIM has submitted an application for 510(k) approval from the Food and Drug Administration for the extended use of its CoaguChek prothombin time (PT) test system to include patient self-testing.
DIASYS Corporation, Islip, NY and BAYER, Diagnostics Division Canada have entered into a strategic cooperation agreement to joint market their urinalysis workstations to hospital and clinical reference laboratories in Canada. DiaSys designs, develops, manufactures and distributes workstation-products which standardize and reduce the cost of analyzing urine sediment and fecal concentrates.
CHEMTRAK, Sunnyvale, CA has received marketing clearance from the U.S. FDA for its rapid test for Helicobacter pylori. ChemTrak test is an inexpensive, disposable, single-use, whole- blood vehicle that renders a "yes" or "no" result on the presence of H. pylori antibodies. The test has received marketing clearance for use by doctors and other clinicians in office or clinical settings.
DPC, Diagnostic Products Corp., Los Angeles, CA, a has received approval from the FDA to market its prostate specific antigen PSA kit on IMMULITE, DPC's automated, chemiluminescent immunoassay analyzer.
Home Access Health Corporation, Hoffman Estates, Ill, has received clearance from the U.S. FDA to market Home Access Express and Home Access, an HIV-1 testing and counseling systems to allow people nationwide to anonymously collect a blood sample, access professional pre-test and post-test counseling 24-hours a day, seven days a week, and receive test results in either three business days or one week, depending on the type of collection kit purchased. The retail prices for Home Access Express and Home Access will be $49.95 and $39.95, respectively, with a portion of proceeds donated to HIV/AIDS service organizations.
ID BIOMEDICAL CORP., Vancouver, has announced positive results from the first clinical trial of its rapid culture confirmation test for methicillin-resistant Staphylococcus aureus (MRSA). The test, which detects the mecA gene responsible for drug resistance, is based on ID Biomedical's proprietary DNA- based diagnostic system. The test was able to discriminate with complete accuracy (100 percent sensitivity and 100 percent specificity) the presence or absence of the mecA gene in a blinded study of 112 clinical isolates of MRSA and regular staphylococcus. The clinical isolates were supplied by two hospital laboratories, one in Canada and one in the United States. The test is based on the company's proprietary DNA-based diagnostic system called Cycling Probe Technology (CPT).
MATRITECH's Inc., Newton, MASS, NMP22 Test Kit has been approved for sale in the U.S. by the FDA for use in identifying patients at risk for recurrence of bladder cancer. The Matritech NMP22 Test Kit is the first Nuclear Matrix Protein (NMP)-based diagnostic product to be approved by the FDA for sale in the United States. The test was found to be twice as sensitive as urine cytology. The test is a painless, low-cost and quantitative tool for the prognosis of transitional cell carcinoma (TCC) of the urinary tract, which accounts for more than 90 percent of bladder cancer.
ONCOR, Gaithersburg, MD has obtained an exclusive, worldwide license for a blood test capable of detecting early-stage breast cancer. After FDA approval, Oncor initially intends to market the blood test as a companion to conventional mammograms of women at high risk for the disease. The p43 test detects an early immunological event in the body's response to the development of primary breast cancer that can be measured in patient blood, particularly with respect to women at high risk for breast cancer. The assay was developed at Tel Aviv University's Sackler School of Medicine. The Company intends to market the test to complement its INFORM(TM) HER-2/neu gene amplification test, which is currently under review by the FDA for use in the management of breast cancer.
PACE Corp., Toronto has acquired rights to market and distribute an easy to use and rapid diagnostic test to detect the presence of HIV antibodies that are associated with AIDS. One unique characteristic is that the test simultaneously detects and differentiates HIV1 and HIV2 antibodies. The Pace HIV test takes only five minutes to perform and is easily used by health professionals.
SDS, Saliva Diagnostic Systems Inc., Vancouver, WASH, will begin preparations to submit its rapid, non-laboratory tests for HIV and the Helicobacter pylori bacteria for U.S. Food and Drug Administration approval.
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