FDA Approves Cytomegalovirus Viral Load Test
Roche announced premarket approval from FDA for a new test to assess a patient's viral load of cytomegalovirus (CMV). The automated COBAS Ampli-Prep/COBAS TaqMan CMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. Physicians use CMV DNA viral load information from the test to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune systems have been suppressed for solid organ transplantation. Roche's new real-time polymerase chain reaction (PCR)-based CMV test is designed for use on the fully automated COBAS AmpliPrep/COBAS TaqMan System, an established platform for viral load monitoring of multiple infectious diseases. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution. Roche expects to begin shipping the new CMV test kit in the third quarter of 2012.
Nanosphere Receives FDA Nod for Gram-Positive Blood Culture Test
FDA has granted a de novo petition permitting marketing of Nanosphere's Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene System. The Verigene BC-GP test provides fast genus and species level detection for a broad panel of clinically significant gram-positive bacteria and also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin. The BC-GP test provides identification of bacteria and antimicrobial resistance genes from gram-positive blood culture bottles within 2½ hours, as compared with current microbiological methods that take up to 3 days. De novo approval from FDA is a special program that fast-tracks novel, clinically important products.
Immunetics Receives FDA Clearance for BacTx Rapid Test
Immunetics received FDA clearance for its BacTx rapid test for bacterial contamination in platelet units. The FDA clearance allows use of the BacTx test on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to FDA, the BacTx test detected all of the bacterial strains tested, with sensitivity and specificity meeting or exceeding clinical requirements. Existing approaches to the detection of bacterial contamination rely mainly on the culturing of the platelet units, a method that takes up to several days to yield a result. The BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient.
FDA Approves Multimarker PSA Test
Beckman Coulter announced FDA approval for the company's Prostate Health Index (phi), a composite score of p2PSA, free PSA, and PSA that estimates the likelihood of a biopsy being found to contain cancer. The blood test is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4–10 ng/mL range and, in trials, reduced the number of prostate biopsies. Results of phi's multi-center clinical study showed a 31% reduction in unnecessary biopsies. The phi test will be available in the U.S. in the third quarter of 2012 for use on the company’s Access 2 and UniCel DxI immunoassay systems.