January 19, 2021 Intelligence: Late-Breaking Lab News

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Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 molecular tests, 68 antibody tests, and 13 antigen tests. Of the 236 molecular tests, 32 are authorized for use with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter at-home antigen test.

23ANDME RAISES $82.5 MILLION IN NEW CAPITAL

23andMe of Sunnyvale, Calif., disclosed that it raised $82.5 million in new funding in a Series F round led by Sequoia Capital and NewView Capital. News reports indicated that it wanted to raise $85 million, but lack of investor interest caused it to close the funding round with $82.5 million. Now that the tidal wave of consumers wanting to do genetic tests to learn about their ancestry and family trees is subsiding, companies like 23andMe and Ancestry are looking for other products and services to sell. In the case of 23andMe, the company hopes to use the genetic data it says it has on 12 million people to collaborate with the development of therapeutic drugs. It entered into one such deal in 2018 with GlaxoSmithKline.

CHANGE HEALTH TO BE ACQUIRED BY UNITEDHEALTH

On Jan. 6, it was announced that Change Healthcare would be acquired by Optum, a division of UnitedHealth. The purchase price is $8 billion and the press release issued by the two companies described the transaction as “combining” the two businesses. The two companies also said, “Change Healthcare will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory, and revenue cycle management offerings to help make healthcare work better for everyone.” Many clinical laboratories use services from Change Healthcare, including lab test billing and collection services.

UNITEDHEALTHCARE AGAIN DELAYS TEST LAB TEST REGISTRY

Last month, UnitedHealthcare (UHC) announced that it would delay implementation of its Laboratory Test Registry Protocol until January 1, 2022. This is the third time that UHC has moved back the start date for the cumbersome program. UnitedHealthcare is requiring nearly all tests and panels used by in-network medical laboratories to be registered. After January 1, 2022, UHC will not pay for claims for clinical laboratory tests and panels that are not registered.

That’s all the insider intelligence for this report.  Look for the next briefing on Monday, February 8, 2021.

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