The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing.

My Life Technologies Corp. has raised $4 million from investors to fund production and clinical trials for its microneedle technology. Based in Leiden, Netherlands, the company is developing a ceramic patch that can deliver vaccines or drugs through the skin. The technology could prove to be an attractive alternative to standard vaccine injections due to what the company says is its simple and painless delivery.

The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.

Color Health Inc. followed its rainbow to another pot of gold, collecting $100 million in a series E financing round led by Kindred Ventures and funds advised by T. Rowe Price Associates Inc. Returning funding round participants also included General Catalyst, the company’s long-time lead investor, Viking Global Investors and Emerson Collective. With the latest cash infusion, the company’s total funds raised to date reached $378 million and its valuation of $4.6 billion propelled it into the top dozen health care unicorns. Founded in 2017 as Color Genomics, the Burlingame, Calif.-based company has raised more than two-thirds of its total funding this year with today’s series E following the close of a $167 million series D round in January.