The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification.
Researchers at Ben-Gurion University of the Negev (BGU) presented a new artificial intelligence technique that could protect medical imaging systems from hacking and human errors at the 2020 International Conference on Artificial Intelligence in Medicine (AIME) on Aug. 26. Their innovative solution uses a dual-layer architecture that screens for two different types of anomalous instructions to capture those that are always unusual or outside of safe ranges and those that are inappropriate in the specific context.
Keeping you up to date on recent developments in diagnostics, including: A.I. tool promises faster, more accurate Alzheimer's diagnosis; Bioluminescent tool tracks DNA break repair; Mechanisms of retinopathy come into focus.
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.
The idea of patent pools such as the COVID-19 Technology Access Pool (C-TAP) created by the World Health Organization a few months ago has drawn a lot of support from low- and middle-income countries and a handful of wealthier ones, but not so much from industry.
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.
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