The US Food and Drug Administration (FDA) has granted CLIA waiver for the Alere Inc's the Alere i Strep A test, the first molecular platform that detects group A streptococcus (GAS) bacteria in 8 minutes or less.

The test was cleared for marketing by the FDA in April 2015. With CLIA waiver, the Alere i Strep A test will be available in a broad range of healthcare settings, including physician offices, hospital emergency rooms, and retail and walk-in clinics in the United States.

"Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others. With CLIA waiver for the Alere i Strep A test, we can help link more people to early treatment by bringing rapid molecular diagnosis to even more settings where they seek health care," said Avi Pelossof, global president of infectious disease at Alere.

The Strep A test is the second assay on the Alere i molecular platform, which initially received 510(k) clearance for the detection and differentiation of influenza A and B virus in 2014. In January 2015, Alere i Influenza A & B became the first-ever molecular test to receive CLIA waiver.

Alere i Strep A detects GAS bacteria in throat swab specimens using Alere's proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT). Unlike polymerase chain reaction (PCR) tests, iNAT does not require lengthy and complex thermocycling or DNA purification and can therefore deliver PCR-caliber results more quickly and in a broad range of settings.

Other assays currently in development on the Alere i platform include respiratory syncytial virus (RSV), C. difficile and chlamydia/gonorrhoea.

GAS bacteria spread through contact with droplets from an infected person's cough or sneeze, and live in a person's nose and throat. Most GAS infections cause relatively mild (noninvasive) illnesses such as strep throat, scarlet fever, and impetigo (a skin infection). More than 10 million non-invasive GAS infections (primarily throat and superficial skin infections) occur annually in the U.S. Occasionally, these bacteria can cause severe and even life-threatening (invasive) diseases. Cases of invasive GAS infections, such as necrotizing fasciitis and streptococcal toxic shock syndrome, occur less frequently but are associated with higher rates of deaths.

Headquartered in Waltham, Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology.