New blood test improves prostate cancer detection
Beckman Coulter, Inc. (Brea, Calif.) has received FDA approval for the Prostate Health Index (phi), a simple, blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range. The test has been shown to reduce the number of prostate biopsies. The results of multicenter clinical tests of the new test showed a 31% reduction in unnecessary biopsies.
The new test helps healthcare providers distinguish prostate cancer from benign conditions. Phi will be available in the third quarter of 2012 for use on the company's Access 2 and UniCel Dxl immunoassay systems.
New HIV viral load test approved
Roche (Pleasanton, Calif.) has received marketing approval for the company's COBAS TaqMan HIV-1 Test V2.0. The new test targets two highly conserved regions of the HIV-1 genome and avoids any regions that are current drug targets, providing increased reliability compared with other single-target assays should a mutation occur.
The test uses the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection.
Thin, full-length electrode for cochlear implantation
Cochlear Americas (Centennial, Colo.) was granted FDA approval for the Nucleus CI422 with Slim Straight Electrode, the newest electrode in its portfolio of implantable hearing solutions.
The new electrode is uniquely designed to preserve delicate cochlear structures and deliver the best-possible hearing performance. The electrode accommodates specific anatomy preferences and techniques in the widest range of patient conditions.
The Nucleus CI422 allows for a smooth, single-motion insertion, and minimal trauma. It features a patented Softip and half-banded contacts for a smooth silicone lateral wall surface.
FDA OKs Gram-positive blood culture test
Nanosphere, Inc. (Northbrook, Ill.) has received marketing approval from the FDA for the company's Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene system.
With a single automated test, the Verigene BC-GP test provides fast genus- and species-level detection for a broad panel of clinically significant Gram-positive bacteria. The test also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes.
Identification of bacteria and antimicrobial resistance genes from Gram-positive blood culture bottles are available within 2.5 hours, compared with current microbiological methods, which can take up to 2 to 3 days.
Genetic test may help some colon cancer patients
The FDA recently approved the first genetic test that can help some colorectal cancer (CRC) patients as well as their providers determine if the drug cetuximab would be effective treatment based on the absence of a gene mutation.
The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has metastasized to other parts of the body. Studies have found that cetuximab is not effective in those who have the mutation.
The therascreen KRAS RGQ PCR Kit was developed by QIAGEN Manchester Ltd., of Manchester, England.