The U.S. FDA has expanded the emergency use authorization for the Labcorp PCR test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy. Labcorp, of Burlington, N.C., explained in an accompanying statement, however, that the Pixel kits only will be available to health care workers and first responders in the early going. It will be available to consumers “in the coming weeks.”

Biofourmis buys Gaido Health to gain complete oncology solution

Biofourmis acquired Los Angeles-based Gaido Health from Takeda Pharmaceuticals in a move designed to significantly expand the company's oncology offerings. Gaido Health's solution will be integrated into Boston-based Biofourmis' Biovitals platform, enhancing its ability to remotely monitor oncology patients at home using a single sensor. The company sees its end-to-end offering as key to reducing cancer patients' post-treatment visits to the emergency department and hospital admissions and bringing down the cost of care, Biofourmis CEO Kuldeep Singh Rajput told BioWorld.

Israeli startup Pi-Cardia raises $27M to test aortic valve treatment that offers TAVR alternative

Pi-Cardia Ltd. has raised a $27 million financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment. Its Leaflex Performer catheter performs mechanical scoring of the calcification at multiple locations in the aortic valve, thereby restoring its flexibility and improving its hemodynamics. This approach could offer an alternative to transcatheter aortic valve replacement (TAVR), particularly for elderly patients and those with complications that make them poor TAVR candidates. It also could hold hope for younger patients in order to delay TAVR and limit the necessity for replacement.

Artificial retina program wins $5M NASA award

Farmington, Conn.-based biotech startup Lambdavision Inc. is preparing to test the benefits of microgravity in producing its protein-based artificial retina, thanks to a $5 million, three-year award from the National Aeronautics and Space Administration. The first-of-a-kind treatment aims to restore vision to people who have lost all or much of their sight due to advanced retinitis pigmentosa. It is expected to have future applications in age-related macular degeneration, the leading cause of blindness in adults 55 and older.

Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other diseases amid the pandemic granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma. Company shares (NASDAQ:INCY) rose 1.2% by midday as the medicine became one of multiple drugs the agency approved this year well ahead of their assigned PDUFA dates. Action on Pemazyre had been expected sometime around May 30.

Free access to BioWorld coronavirus articles

The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. Note that we have added three critical tables which are constantly updated:

Also in the news

Advarra, Amc Health, Archerdx, Brainlab, Centogene, Cerehealth, Cerus, Curetis, Evicore Healthcare, GE, Inspire Medical Systems, Iridex, Karolinska Institutet, Kurin, Labcorp, Nemaura, Opgen, Oxford Immunotec, Personal Genome Diagnostics, Premier, Roche, Science 37, Simplify Medical, Todos Medical