SiDMAP, LLC, has expanded its SiDTox™ services to enable rapid and specific detection of drug-induced organ toxicity. Using its proprietary metabolomics technology platform, SiDMAP is able to monitor changes in vital metabolite fluxes in response to drug treatment to quickly determine organ toxicity before structural or morphological damage occurs. On the basis of a research performed by SiDMAP along with the Center for Metabolomics at the FDA National Center for Toxicological Research, SiDTox™ will now include an affordable and non-invasive test that will allow researchers to detect drug-induced toxicity before organ damage.

The U.S. Food and Drug Administration has given approval to Chembio Diagnostics, Inc. to extend the age range for its HIV rapid point-of-care testing by lowering the age limit to 13 years and above from 18 years. The Laboratory of Viral Diagnostics, University of Maryland School of Medicine, conducted a clinical study and recommended the expansion of age limit on the basis of the study’s findings. The test can be carried out in primary care settings.

The U.S. Food and Drug Administration has cleared the Tosoh G8 which offers pinpoint precision with the industry’s lowest CVs of less than 2%. The instrument-reagent system uses the gold standard ion-exchange method of HbA1c levels testing to monitor glycohemoglobin in diabetic patients effectively. The system’s automatic start-up and touch-screen operation make it very user-friendly. Also, it fits in most of the laboratory environments easily. The G8 is a diagnostic system for measurement of HbA1c in samples of blood.

The U.S. Food and Drug Administration (FDA) has approved GE Healthcare’s molecular imaging agent AdreView™ (Iobenguane I 123 Injection) for the detection of rare neuroendocrine tumors in children and adults. The product provides images of high quality that assist physicians in the detection of tumors, at the initial stage as well as at the time when relapse is suspected. AdreView™ marks an advancement in diagnosis of cancer patients suffering from neuroblastoma. It will also identify primary and metastatic pheochromocytoma.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MiCardia Corporation for marketing its Dynaplasty™ Annuloplasty Band DR™ and Annuloplasty Ring DR. These are the company’s first  Dynaplasty technology products to receive this clearance. Welcoming this approval MiCardia CEO, Paul Molloy commented that it involved extensive technical validation of the Company’s first generation annuloplasty system. He said, “It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the Company’s DYANA Phase I human study in Europe”.

The PreMD’s appeal over the NSE (not substantially equivalent) letter it received for a premarket submission to expand indications for its skin cholesterol test has been upheld by the FDA.  The FDA agreed that the clinical trial data was not sufficient to say if the product was substantially equivalent to other markers of cardiovascular risk.

CVT Therapeutics Inc. has received FDA approval for its injection for the detection of coronary artery disease . The Lexiscan injection is designed as a pharmacologic stress agent in the testing to detect and characterize coronary artery disease for patients who are unable to undergo adequate exercise stress.

The FDA has sent an NSE (non-substantially equivalent) letter to PreMD Inc. related to the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. “We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease,” the company said. The FDA has rejected the claim citing concerns over the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint.

Quidel Corporation has announced that the FDA has granted a CLIA (clinical laboratory improvement amendments) waiver for the QuickVue test. This test enables the qualitative detection of the respiratory syncytial virus (RSV). The American Academy of Pediatrics has recognized RSV as the primary cause of pneumonia and bronchiolitis in children of 2 years of age and below. The waiver allows the QuickVue RSV test to be made more widely available for use, especially in clinics and offices of physicians, where waived tests are used most frequently.