KeyPath MRSA/MSSA Blood Culture Test Approved
The FDA has cleared the KeyPath MRSA/MSSA Blood Culture Test to determine whether bacteria growing in a patient’s positive blood culture sample are MRSA or MSSA.
Diagnostic Agents
First Response Digital Ovulation Test Available
Church & Dwight has launched the at-home First Response Digital Ovulation Test, which detects a woman’s personal luteinizing hormone (LH) surge based on her individual baseline hormone levels.
cobas HPV Test Available to Detect Human Papillomavirus
Roche announced that the FDA has approved the cobas HPV Test, which is now available, to identify women at highest risk of developing cervical cancer.
Cepheid Xpert C. difficile/Epi Assay Approved
The FDA has approved Cepheid Xpert C. difficile/Epi assay for the detection of the toxin B gene associated with Clostridium difficile infection.
DaTscan radiopharmaceutical agent approved for detection of dopamine transporters
The FDA has approved DaTscan (Ioflupane I 123 Injection, from GE Healthcare) for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes.
FDA Video: Preventing Infections When Monitoring Blood Glucose
FDA and CDC are alerting healthcare professionals about the risks of transmitting hepatitis B virus (HBV) and other infectious diseases when monitoring blood glucose.
Abbott Glucose Test Strips recalled due to false low blood glucose results
The FDA and Abbott Diabetes Care have notified healthcare professionals and patients of a recall of 359 lots of glucose test strips marketed under the brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima.
Trio all-in-one blood glucose meters
Pepex Biomedical announced the development of Trio, a multi-function, single-unit blood glucose meter product line, which tests blood glucose levels and delivers insulin.
Phase 2c study of PH-10 for the treatment of plaque psoriasis
Provectus has initiated a Phase 2c clinical trial of PH-10 for the treatment of mild-to-moderate plaque psoriasis.
xTAG CYP2D6 Kit pharmacogenetic test launched
Luminex announced that it has launched its pharmacogenetic test, the xTAG CYP2D6 Kit, which is approved by the FDA to help identify individuals who possess both common and rare CYP2D6 poor-metabolizer variants.
