The following is a review of diagnostic product developments worldwideThe information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.
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.
Product developments in March 2003
Ark Therapeutics Ltd. is developing a point of care test kit for cardiovascular disease that measures levels of auto-antibodies against Oxidised-Low Density Lipoproteins (Ox-LDL). Ark’s test kit will be assessed for its accuracy to predict which patients will suffer heart attacks and other serious cardiovascular events.
Bayer Diagnostics has introduced a complete panel of high throughput automated Hepatitis B assays designed to run on the ADVIA Centaur immunoassay system that includes tests for HBsAg, HBCoreTotal and HBCoreIgM.
Bayer has also received FDA clearance to market for Ascensia Breeze, its newest blood glucose monitor expected to be commercially available Q3 2003. The device is the first to use the Ascensia AUTODISC 10-test disc.
Biosite Incorporated has received FDA clearance to market the Triage Cardio ProfilER as an aid in the diagnosis of myocardial infarction and for the risk stratification of patients with acute coronary syndromes.
Digene Corp. has received FDA clearance to market the HC2 High-Risk HPV DNA Test to detect the human papillomavirus with a Pap smear in screening any woman older than 30.
Focus Technologies announced the April 2003 availability of laboratory reagents for detecting Flavivirus (West Nile Virus) antibodies using a recombinant protein antigen licensed from the Centers for Disease Control and Prevention (CDC). Focus will manufacture and distribute ELISA Flavivirus reagents in 2003 to public health departments and to commercial laboratories and hospitals.
Chiron Corporation and Gen-Probe Incorporated have received submitted an IND for their Procleix NAT assay to screen blood donations for West Nile virus.
diaDexus, Inc. is providing analyte specific reagents to Mayo Medical Laboratories. Mayo will use these reagents to develop a test for the quantitative measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) in blood.
Healthy Estrogen.com, Inc. has introduced The Healthy Estrogen Test, a urine test that will help women evaluate risk for breast cancer with the measurement of estrogen metabolites in determination of an estrogen metabolism ratio, known as the 2/16 ratio. A low ratio has been associated with increased breast cancer risk.
HemoSense, Inc. has introduced its CLIA waived INRatio Prothrombin Time (PT) Monitoring System for patient self-testing at home and for use by medical professionals.
Matritech has been notified by the FDA of the approvable status for its NMP22 BladderChek as a urine screening test that physicians can use in their offices to help diagnose patients with bladder cancer.
Spectral Diagnostics Inc. has received FDA clearance to market its Endotoxin Activity Assay (EAA) to identify patients at risk for developing severe sepsis on admission to an ICU.
SpectRx, Inc. has sold its BiliChek Non-invasive Bilirubin Analyzer product line and related assets to Respironics Inc. Proceeds from the sale will go to fund the expansion of SpectRx's SimpleChoice diabetes product line and the development of a continuous glucose monitor.
Targeted Diagnostics & Therapeutics Inc. has received FDA clearance to market its new blood test, called GCC-B1 for the detection of recurrent colon cancer. TDT says their new test represents a major breakthrough because its detection mechanism finds metastatic colorectal cancer that is often missed by other methods. The company says that GCC-B1 can find one cancer cell in 10,000,000 normal cells by detecting the presence of guanylyl cyclase C (GC-C), which is found on metastatic colorectal cancer cells.
Product developments - February 2003
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Last modified: April 1, 2003