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.
Roche Diagnostics has received FDA marketing approval for its AMPLICOR HIV-1 MONITOR UltraSensitive Method. The test can measure down to 50 copies of virus per milliliter of plasma.
ID Biomedical Corporation has filed a 510(k) application with the US Food and Drug Administration (FDA) for its Velogene Rapid MRSA Assay, a rapid gene identification test for methicillin resistant Staphylococcus aureus from culture. The assay is based on the company's proprietary gene identification technology, Cycling Probe Technology (CPT) and takes approximately 90 minutes after primary culture to identify the MecA gene, which is believed to be responsible for methicillin resistance.
Millennium Predictive Medicine, Inc., a wholly-owned subsidiary of Millennium Pharmaceuticals, Inc. has entered into a strategic alliance with Becton Dickinson and Company to develop tests designed to provide individualized diagnostic and prognostic information, assist in treatment selection for patients with cancer. The first products will detect melastatin is a protein identified by Millennium in 1994 and which may function as a metastasis suppressor in malignant melanoma.
Biex, Inc., has developed the SalEst System, a non-invasive clinical marker for identifying risk for spontaneous preterm labor and delivery which measures levels of estriol in saliva.
Chiron Diagnostics announced that it has initiated the Premarket Approval Application (PMA) process for the Quantiplex HIV-1 RNA 3.0 Assay (bDNA). The test incorporates third generation branched DNA (bDNA) technology for quantitation of HIV-1 viral load in human plasma. The test is already approved for in vitro use in France and Australia. The Quantiplex HIV-1 RNA 3.0 assay runs on the Chiron Quantiplex 340 Automated bDNA System and has a broad dynamic range (50 to 500,000 copies/mL).
VIA Medical Corporation has launched its Low Volume Mode (LVM) Blood Gas and Chemistry Monitor for use in neonatal and pediatric intensive care units. LVM is a closed-loop blood analysis device for neonates that provides clinicians with results of blood chemistry tests in real-time by pulling a small amount of blood out of the infant's existing arterial line into a special sensor. After analysis, the blood is then automatically returned to the infant.
Instrumentation Metrics, Inc., is nearing commercialization of a non-invasive glucose device that uses near-infrared (NIR) spectroscopy.
HDC Corporation has received 510(k) FDA approval to market its Entero-Test, a device that utilizes a string absorption configuration to retrieve organisms from the stomach. Once retrieved, the diagnosis can be accomplished by culture, histology or with commercially available urease media's.
Alliance Instruments has received 510K approval to market the integriti system, a Windows-based portable monitoring and bedside management of patient information. Offering automated profiling (screen setup) in any clinical setting, integriti monitors noninvasive blood pressure, Sp02, 30-second temperature and ECG and two invasive blood pressures if needed. Optionally, it provides a C02 input and full graphics strip recording capability.
Bayer Corporation, Diagnostics Division has launched the Glucometer DEX Diabetes Care System, a "no-strip" blood glucose meter that allows people with diabetes to perform 10 tests with a single cartridge stored in the meter. The device uses "sip-in" technology to draw a small amount of blood (3-4 microliters) into the test sensor. The Glucometer DEX System produces results in just 30 seconds and can show results of the user's two most recent tests, a two-week average of test results, time-specific averages and individual test results. The WinGlucofacts software program allows users to transfer test results to a personal computer to log, summarize and calculate averages from all test results.
Digene Corporation has received US FDA market clearance for its Hybrid Capture II HPV Test, a DNA-based technology to detect the human papillomarvirus. Digene expects to launch the test in the United States spring 1999. Digene's assay detects up to 90% to 95% of high grade cervical disease. The Digene HPV Test is used as an adjunct to the Pap smear for cervical cancer screening.
ABAXIS, Inc. has signed an OEM agreement with Melet Schloesing Laboratoires of France to provide a hematology analyzer, the VetScan HMT. Melet will, in turn, distribute the Abaxis VetScan chemistry analyzer in France. Shipments of the VetScan HMT Analyzers are scheduled to commence Spring 1999. The addition of hematology to the VetScan family of products allows Abaxis to offer its customers a complete POC laboratory package consisting of chemistry, electrolytes and hematology.
Matsushita Electric Industrial Co., Ltd., known for its Panasonic and National brand products worldwide is developing an optical urine protein test technology and device, which automatically tests for urine protein without the use of a test strip or reagents. The device takes advantage of the characteristics of urine protein. Heating of urine results in the aggregation of urine protein, causing the urine itself to emulsify . The resulting protein is measured optical laser technology.
Trinity Biotech plc has received US FDA clearance to market its Uni-Gold Strep A test, a rapid, qualitative assay for Strep A antigen which can be carried out directly on throat swabs giving results in minutes. The assay is a simple, rapid, membrane format test which provides visually-read color results to detect Streptococcal A. The Strep A test is the first non-pregnancy Uni-Gold product to have U.S. FDA clearance.
SpectRx, Inc. has received US FDA clearance to market its BiliChek, non-invasive Bilirubin Analyzer. The product will be distributed in the U.S. by Respironics. The BiliChek is currently available in 45 other countries. BiliChek uses biophotonic technology to replace the heel stick blood test by shining light on an infant's forehead, then analyzing light that is reflected back.
Cholestech Corp. has announced that the Health Care Financing Administration (HCFA) has added Cholestech's glucose assay, performed on the Cholestech L.D.X System, to the list of CLIA waived tests approved for glucose tolerance testing. The Cholestech L.D.X System is currently the only system waived under CLIA '88 that can conduct multiple simultaneous diagnostic tests.
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