Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time it promised. However, questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes as a result of a study conducted at the New York University Langone Medical Center that claims the diagnostic compared poorly against the Cepheid Xpert Xpress test. Despite this finding, the U.S. FDA is holding pat on the ID Now’s registration in the emergency use authorization for diagnostic testing. This is in part because the agency has some questions about “the types of swabs … or the type of viral transport media” used in some of these non-peer reviewed studies, a point the company itself has made in recent weeks.

Startup C2n raises $20M to back Alzheimer’s blood test to FDA approval

C2n Diagnostics LLC has received a $20 million investment in its Alzheimer’s blood test, APTUS-Aβ, from the philanthropy group GHR Foundation. The test measures various types of amyloid beta in the blood and then factors in additional data, such as age, to develop a probability score for amyloid-related pathology in the brain. The St. Louis-based startup was founded by David Holtzman and Randall Bateman, of Washington University School of Medicine, and venture firm Lifetech Research.

Intrasense obtains CE mark for its CT scanner protocol designed for COVID-19

PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.

Wave Guard’s algorithm-based solution aims to aid in contact tracing

HONG KONG – Contact tracing is seen as one of the more effective measures to contain the current COVID-19 pandemic. Now, an Israeli company may hold the solution with its app-free tech. Herzliya-based Wave Guard Technologies Inc. has an algorithm-based solution that allows government health care agencies to trace contacts of COVID-19-infected individuals accurately, effectively and in real time.

Health Canada approves PMX treatment for sickest COVID-19 patients

TORONTO – The Toraymyxin hemoperfusion cartridge developed by Toronto’s Spectral Medical Inc. and used successfully to treat patients during the avian and swine flu pandemics is being eyed to help COVID-19 patients in Canada. Specifically, an emergency interim order from Health Canada expands its use to include treatment of COVID-19 patients with high levels of endotoxin in their blood and in acute respiratory failure. “This is for end-stage patients who are in septic shock,” Paul Walker, Spectral’s president and CEO, told BioWorld. “We know that some COVID patients are endotoxemic, and that, in those circumstances, there may be a good use for our hemoperfusion adsorption cartridge by taking endotoxin out of the bloodstream.”

Peijia raises $302M on HKEX to advance TAVR product, shares up 70% on debut

BEIJING – Suzhou, China-based Peijia Medical Co. Ltd. became the second prerevenue med-tech company to go public on the Hong Kong Stock Exchange after Venus Medtech (Hangzhou) Inc., pocketing HK$2.3 billion (US$302 million) with an aim to develop and commercialize its transcatheter valve therapeutic medical device called Taurusone. The firm issued 152 million shares globally under the ticker 9996, and its shares were oversubscribed in Hong Kong by 1,184.41 times. Riding on investors’ enthusiasm for health care stocks in recent months, Peijia’s share price rose nearly 70% from its offer price at HK$15.36 to close at HK$25.80.

Diagnosing the state of COVID-19 testing

The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTech explores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.

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A*STAR, Balt, Beyond Air, C3.ai, Caredx, Centogene, Duke-NUS, Genscript, Guardant Health, Hologic, Integra Lifesciences, Mesa Labs, Microbix, Microsoft, Pulse Biosciences, Roche, Unitedhealth Group