Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

The FDA has approved a test for women who have developed tumors in the pelvic region known to need surgery. The test, OVA1, will be helpful for doctors in deciding if the tumor is an ovarian cancer and what should be their procedure to advance towards surgery. OVA1 can even detect ovarian cancer in women who have received negative results from standard cancer tests. The test, which has been developed by Vermillion Inc in collaboration with scientists at The Johns Hopkins University in Baltimore, can also identify women whose surgical cases will benefit from the involvement of a gynecological oncologist.

Molecular-diagnostic company Cepheid has received the Food and Drug Administration (FDA) approval for a test that helps in rapid diagnosis of a bacteria linked to antibiotic-resistant infections. Cepheid’s Xpert C.difficile test can detect within 45 minutes a bacterium that causes the Clostridium difficile infection, resulting in diarrhea and more serious intestinal conditions, such as colitis.

Medtronic Inc announced the approval of its Attain Ability left-heart lead (Model 4196) by the U.S. Food and Drug Administration (FDA) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients. Attain Ability has the thinnest lead body of any left-heart lead currently available, providing physicians with a tool to deliver therapy directly to hard-to-reach areas of the heart.

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.