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FDA clears LabCorp’s COVID-19 home collection kits as Congress looks to bolster testing with $25B

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.

LabCorp became the first diagnostic company to have an at-home collection kit for COVID-19 authorized by FDA, a month after the agency cleared its lab PCR test for the novel coronavirus. FDA also gave a green light to a Phase II trial of aTyr’s fusion protein Tuesday to treat COVID-19 patients with severe respiratory complications.

Laboratory Corp. of America Holdings (NYSE:LH) plans to make its home collection kits available in most states, with a doctor’s order, in the coming weeks. After collecting a nasal sample by self-swabbing, a user would mail their sample in an insulated package to a LabCorp lab for testing.

FDA first granted Emergency Use Authorization (EUA) to LabCorp’s reverse transcription-polymerase chain reaction (RT-PCR) lab test on March 17 (see “FDA Expanding U.S. COVID-19 Test Capacity”).

Separately Tuesday, the U.S. Senate passed by a voice vote an expansion to the Coronavirus Aid, Relief, and Economic Security (CARES) Act that would provide an additional $25 billion to HHS to bolster testing. The bill goes next to the House of Representatives.

aTyr looks to start trial of immune modulator

aTyr Pharma Inc. (NASDAQ:LIFE) plans to enroll 30 severe COVID-19 patients at up to 10 U.S. sites in its randomized, double-blind, placebo-controlled Phase II trial of ATYR1923.

ATYR1923 modulates NRP2 to downregulate innate and adaptive immune responses by dampening inflammatory cytokine and chemokine signaling associated with severe cases of COVID-19 (see “Matching Therapeutic Mechanism to Disease Stage”).

aTyr said that in multiple animal models of immune-mediated acute lung injury, ATYR1923 improved lung function while reducing inflammation and fibrosis.

The fusion protein is in a Phase Ib/IIa study of pulmonary sarcoidosis, which reported interim safety data in December.

According to BioCentury’s COVID-19 Resource Center, more than 150 therapeutics are in the clinic for COVID-19.

CMS offers clinicians credit for trial participation

CMS said Monday that clinicians who participate in its Quality Payment Program (QPP) can earn credit in the agency’s Merit-based Incentive Payment System (MIPS) by participating in a clinical trial for a COVID-19 treatment and reporting data.

Clinicians can report their findings through a clinical data repository or registry, including Oracle’s Therapeutic Learning System online portal (see “Oracle Portal Offers Doctors Online Reporting System”).

MIPS is a performance-based track of QPP aimed at incentivizing quality and value.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.


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