Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.

The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.

Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.

Hologic Inc. beat expectations for the third quarter of fiscal year 2020, posting net earnings of $137.9 million, or 53 cents a share, up 46.9% from the same period a year ago. Worldwide revenue declined 3.5% to $822.9 million, due to the divestiture of Cynosure Holdings Inc., but grew 7.7% organically (8.1% in constant currency), as demand for COVID-19 tests offset a slide in other businesses.

The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

Startup Scipher Medicine, of Waltham, Mass., is developing a blood test to predict which rheumatoid arthritis (RA) patients will not respond to Tumor necrosis factor (TNF) inhibitor therapies.

VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour.

Liquid biopsy startup Thrive Earlier Detection Corp. has raised $257 million in a series B round led by Casdin Capital and Section 32. The funds will be used to finalize the design of its first product, Cancerseek, conduct a trial to support U.S. FDA approval and prepare for commercialization.