A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.

DUBLIN – Liquid biopsy developer Freenome Inc. has – literally – capitalized on its recent proof-of-concept AI-Emerge colorectal cancer (CRC) screening study by raising $270 million in a series C round that will enable the South San Francisco firm to complete its ongoing Preempt CRC registration study and to file for pre-market approval from the FDA.

As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.

LONDON – Biofidelity Ltd. has raised US$12 million in a series A, enabling it to start commercialization of a novel, low-cost, chemistry-based diagnostic for detecting all actionable lung cancer mutations. The Cambridge, U.K.-based company claims the test can detect a single molecule of mutated DNA against the background of billions of healthy molecules in a patient sample, without the need for DNA sequencing.

Through the use of sequencing data, researchers in Hong Kong presented a case study providing the strongest evidence yet that individuals can become reinfected with SARS-CoV-2 after clearing a first infection.

Exo Imaging Inc. closed a $40 million series B+ funding round that is earmarked to help with the development of a hand-held ultrasound device and cloud-based workflow software platform. The funding follows a series B round in August 2019 that reeled in $35 million and brings the company’s total raise to nearly $100 million.

The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.

LONDON – European scale-up of an artificial intelligence tool for stratifying and personalizing treatment of COVID-19 patients according to the type of complications they are likely to experience will get underway in September, following initial validation. The tool, developed by researchers at the Hospital Clinic Barcelona, Spain, was ‘trained’ on more than a trillion anonymized data points retrieved from the clinic’s electronic health records system.

The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.