Alere Inc., a leader in rapid point of care diagnostics market recently announced that its i Strep A test has won FDA (Food and Drug Administration) 510(K) clearance.
Alere’s i Strep A test is the first molecular test that detects group A streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less. This specific bacterium can cause a wide range of infections in the throat or skin without any symptoms of illness. Occasionally, it can cause severe and even life-threatening diseases. According to the reports from CDC, approximately 9,000-11,500 cases of invasive GAS disease occur each year in the United States, resulting in 1,000-1,800 deaths annually.
Based on this FDA approval, Alere has applied for CLIA waiver of the i Strep A test. Using Alere’s proprietary Molecular In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT), the Strep A test detects Group A Streptococcus (GAS) bacteria in throat swab specimens. In the clinical study, 481 throat swab specimens were evaluated with Alere i and compared to standard bacterial culture. The overall sensitivity and specificity of the Alere i Strep A was 95.9%; for bacterial culture, it was 94.6%.
Avi Pelossof, Global President of Infectious Disease at Alere said, “This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A. The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency.”
Alere is known for its wide range of quality diagnostic testing tools that help people live longer and healthier lives. The company’s Triage® BNP Test for the rapid, quantitative measurement of BNP accelerates heart failure treatment decisions and risk stratifies patients with ACS at the point of care or in the laboratory. An efficient point of care testing system, Alere’s Cholestech LDX® System ensures efficient and economical testing for cholesterol and related lipids, and blood glucose, providing the information required for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes.