BD Receives Clearance for Rapid Flu Test
FDA cleared the BD Diagnostics BD Veritor System for Rapid Detection of Flu A+B, for use in clinical settings. The kit is designed for testing liquid specimens obtained via nasopharyngeal wash, aspirate, or swab in transport media. The assay uses BD's proprietary advanced particle and adaptive read technologies, which increase the test's sensitivity and reduce false positives, respectively.
FDA Clears RSV Test
BD Diagnostics received clearance from FDA for a respiratory syncytial virus (RSV) test designed for use on the BD Veritor System. This is the third FDA-cleared test for this platform. Like BD's Rapid Detection of Flu A+B for the BD Veritor System, Rapid Detection of RSV tests nasopharyngeal wash, aspirate, and swab in transport media specimens. It also couples proprietary advanced particle and adaptive read technologies with a digital display to provide objective, easy-to-read test results.
Roche's CoaguChek XS Plus Granted CLIA Waiver
FDA granted CLIA-waived status to Roche's CoaguChek XS Plus system, a point-of-care anticoagulation monitor that helps hospital staff manage prothrombin time/international normalized ratio (PT/INR) testing. Quality controls built into the system ensure the accuracy of PT/INR results, while optional liquid quality controls accommodate facilities where policy requires external quality control measures. The system's connectivity capabilities also help healthcare professionals streamline organization and the regulatory compliance process by allowing them to connect and transfer data to IT solutions.
HIV-1 Viral Load Test Approved
Roche received FDA approval for an HIV-1 test that uses the company's proprietary dual-target approach to improve physicians' viral load monitoring capabilities. The dual-target approach, as its name suggests, targets two highly conserved regions of the HIV-1 genome and avoids regions that are current drug targets. This strategy ensures accuracy even when mutations are present in the viral genome, leading to more reliable test results. The test also combines the High Pure System Viral Nucleic Acid Kit with the COBAS TaqMan 48 Analyzer to provide manual specimen preparation, and automated amplification and detection.
FDA Approves Group A Strep Test
FDA has cleared Meridian Bioscience's diagnostic test for Group A Streptococcus on the Illumigene platform. The Group A Strep bacterium causes a number of different illnesses, including pharyngitis, one of the most common reasons for consultations with primary care physicians. Meridian's test diagnoses pharyngitis by detecting Streptococcus pyogenes in throat samples using loop-mediated isothermal DNA amplication (LAMP) technology. This procedure takes less than an hour, and has the potential to improve upon the accuracy and sensitivity of traditional pharyngitis diagnostics such as rapid antigen testing and throat swab culture.
Focus Diagnostics Receives Clearance for Flu, RSV Test
The Focus Diagnostics Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler received FDA clearance and CLIA moderate-complexity categorization. The test qualitatively detects and differentiates RNA of influenza A and B viruses and the respiratory syncytial virus in nasopharyngeal swabs without the requirement for extracting nucleic acids.
Respiratory Virus Panel Cleared
GenMark Diagnostics received 510(k) clearance from FDA for its eSensor Respiratory Virus Panel (RVP). Intended for use on GenMark's XT-8 system, the test can concurrently detect and distinguish between 14 major viruses that cause influenza-like illness, including rhinoviruses, enteroviruses, and clinically relevant adenoviruses.