The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.

Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances. This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator.

PERTH, Australia – In response to the COVID-19 pandemic, Trajan Scientific and Medical Ltd. and Synexa Life Sciences Ltd. have developed and validated a SARS-CoV-2 serology assay that enables more efficient, population-based monitoring of the longevity of COVID-19 vaccines being deployed and to help determine the timing and deployment of booster vaccinations.

Prenetics Ltd. is working with Oxford University researchers again to develop molecular diagnostic testing for the new COVID-19 variants, six months after it acquired Oxsed Ltd., a University of Oxford University spinoff to enable rapid airport testing. On April 19, Hong Kong-based Prenetics inked a multimillion-dollar partnership with the University of Oxford and Oxford Suzhou Center for Advanced Research (OSCAR) to upgrade the molecular testing technology Oxlamp for infectious diseases.

Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.

Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).

Anyone who has had a malignant tumor removed knows the anxiety that follows. Did any traces of cancer remain, and if it returns, will doctors catch it before it’s too late? To reduce the uncertainty and improve patient outcomes, C2i Genomics Inc. has raised a $100 million series B funding round led by Casdin Capital to advance software that is 100 times more sensitive in detecting residual disease than legacy technologies.

HONG KONG – A professor at the Chinese University of Hong Kong (CUHK) claims that retinal eye scanning can help to improve early detection of autism and treatment outcomes for children. Benny Zee, a professor at CUHK, has developed a method to identify children at risk of autism and get them into treatment programs sooner.

The U.S. Centers for Medicare & Medicaid Services (CMS) has decided to leave the onus on Medicare administrative contractors (MACs) to make coverage determinations regarding the Allomap test for heart transplant rejection despite a request for a non-coverage policy. As was the case in the decision to allow MACs to determine coverage for total artificial hearts, the CMS said that the low annual rate of utilization of the Allomap, by Caredx Inc., of Brisbane, Calif., suggested that the MACs are in a better position to make the appropriate call regarding coverage.