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In the latest sign the US Food and Drug Administration (FDA) is looking to tackle testing shortages and equip US patients with diagnostic coronavirus tests, the agency granted an emergency use authorization (EUA) for a saliva-based coronavirus test developed by Rutgers University’s RUCDR Infinite Biologics biorepository, according to CNBC.
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Saliva-based tests could help ramp up wide-scale coronavirus testing in the US, while protecting frontline healthcare staff and overcoming supply shortages. Rutgers’ test is currently available to the RWJBarnabas Health system in hard-hit New Jersey.
But a larger-scale rollout of the test could be on the horizon, considering the university’s RUCDR lab has the capacity to run 10,000 tests per day and the FDA’s recent EUA should enable other labs to adopt this form of testing, per CNBC. An expanded rollout of Rutgers’ test could help ramp up wide-scale coronavirus testing efforts across the US — which still lags behind other countries such as Italy and Germany in coronavirus tests conducted per million people.
And the nature of Rutgers’ test — which requires individuals with coronavirus symptoms to spit into a cup — could be significant in overcoming testing barriers such as limited supplies and mitigating the spread of the virus among vulnerable healthcare workers. For example, the test eliminates the need for nose and throat swabs — which NYC hospitals currently face a shortage of.
And while healthcare professionals are required to supervise sample collection, the fact that they’re no longer collecting samples themselves limits their potential exposure to the virus and could help hospitals better allocate dwindling supplies of personal protective equipment.
We’re also seeing fast-moving health tech startups like MicroGen DX extending into saliva-based coronavirus testing — but murky home use guidelines could stunt consumer adoption. At-home testing firms’ are also wading into saliva-based coronavirus testing, but their efforts have been hampered by FDA regulatory hurdles, which could further exacerbate the US’ lagging testing efforts.
Texas-based MicroGen DX launched a saliva-based coronavirus test on March 31st for $99. And while the health tech startup indicated its test does not require FDA approval since an accredited lab processes its results, the at-home nature of the test led the FDA to clarify that no coronavirus tests have been authorized for home use, per STAT.
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So, while the rollout of at-home diagnostic tests for the novel coronavirus would fill in testing gaps and mitigate the further spread of the virus by arming individuals with the knowledge that they should self-isolate if infected, the sparring between the FDA and health tech startups could put the brakes on testing wide swaths of the US public — and further delay efforts to restart the US economy in the process.
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