The FDA’s emergency use authorization (EUA) program for rapid antigen tests for the COVID-19 pandemic is coming to an end, but few rapid antigen test makers have laid out clear plans regarding the post-public health emergency world. Quidelortho Corp. managed to beat the competition to the non-EUA market for these tests with a grant of de novo petition for its Sofia rapid antigen test, which now provides other tests with a predicate device, thus ensuring that this will not be the last such test to reach the U.S. market.

Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of $153 million. Friday’s Wall Street debut was a show of confidence, upsized from an original plan to offer 7.8 million shares at $15 to $17. The Emeryville, Calif.-based company has granted the underwriters a 30-day option to acquire up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Lucira Health Inc. has secured U.S. FDA emergency use authorization for the first prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.