Thermo Fisher's COVID tests snare FDA green light for detecting delta and other variants

Since the Centers for Disease Control and Prevention estimated in late July that the COVID-19 delta variant had become the dominant strain in the U.S.—representing about 83% of new cases at the time—case numbers have only continued to skyrocket.

According to the latest CDC data, the seven-day average of new cases has reached more than 114,000 per day, up nearly 20% from the previous week. And, in contrast to earlier strains of the coronavirus, the newer, more infectious mutations pose a higher risk to young people, with the agency reporting a 22% rise in hospital admissions for patients aged 17 and under in the last month.

In response, diagnostic developers have quickly stepped up to develop tests capable of detecting delta and other mutations that the CDC has labeled “variants of concern”—even after many projected that testing demand would peter out throughout the year with the widespread availability of the three FDA-cleared COVID vaccines.

Among these is Thermo Fisher Scientific, which received a new emergency use authorization from the FDA this week to begin rolling out updated iterations of its mainstay TaqPath molecular tests.

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The prescription-only TaqPath kit was initially granted an FDA green light at the onset of the pandemic in March 2020. About a year and a half later, the new versions have added targets in eight genes linked to the virus, spanning three genomic regions. According to Thermo Fisher, testing multiple genes in the same regions will allow the tests to detect a broader variety of COVID mutations, today and in the future.

The company offers two versions of the TaqPath kit. The first, called the RNase P combo kit, follows a standard PCR workflow using nasal and nasopharyngeal swabs from both symptomatic and asymptomatic people, to deliver results in about three hours.

The other, known as the Fast PCR combo kit, skips over the RNA extraction process and aims to detect COVID-19 in raw saliva samples of people showing symptoms, with results within two hours.

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Thermo Fisher’s updated EUA comes not long after Roche scored an FDA nod of its own for a point-of-care molecular test that returns results in just 20 minutes and, per the company, “offers broad strain coverage of SARS-CoV-2 variants.”

And last week, California-based DiaCarta received European CE mark approval for its QuantiVirus test, which both identifies and differentiates between all known variants of the coronavirus, including delta and the emerging delta-plus mutation.

Diagnostics powerhouse Abbott, meanwhile, noted in an Aug. 10 release that its own slate of emergency authorized COVID tests are already equipped to detect the virus’ many mutations. That’s because the BinaxNOW and other kits aren’t based on analyses of the virus’ spike proteins—which vary based on the mutation—and so continue to detect all variants of the virus with consistent accuracy levels.