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.

Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.

Diagnostics testing company Laboratory Corp. of America Holdings Inc. (Labcorp) saw its second-quarter revenue decline by 4% to $2.8 billion, but that still beat the Street consensus of $2.5 billion. Diagnostics revenue fell 3.9% year over year to $1.7 billion, but that was offset by solid demand for the company’s COVID-19 tests.

CYBERSPACE – Data presented at the virtual 2020 Alzheimer's Association International Conference (AAIC) and reported in the July 28, 2020, online issue of the Journal of the American Medical Association (JAMA) demonstrated that blood levels of phosphorylated tau-217 (Ptau-217) did as well as cerebrospinal (CSF)- and PET-based biomarkers, and significantly better than other blood-based biomarkers, at discriminating individuals with Alzheimer’s disease (AD) from those with other neurodegenerative disorders.

PARIS – Therapixel SA, of Nice, France, has obtained 510(k) clearance from the U.S. FDA for its Mammoscreen technology, a software platform based on artificial intelligence (AI) and used by radiologists for reading screening mammograms. “Obtaining FDA clearance is the result of working with radiologists over the past three years in order to develop a powerful tool providing relevant assistance in their day-to-day work,” Matthieu Leclerc-Chalvet, CEO of Therapixel, told BioWorld.