LONDON – Oxford Immunotec plc is aiming to plug a significant gap in the COVID-19 diagnostics landscape, with the development of a commercial clinical grade test for quantifying T cell responses to the SARS-CoV-2 virus. T-Spot Discovery SARS-CoV-2, currently available for research use only, is based on the same automated technology as the company’s tuberculosis diagnostic, which is approved for use in more than 60 countries.

The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.

A team of scientists at Duke Health has identified biomarkers that accurately detect viral infections before a person becomes symptomatic. The findings were published in The Lancet Infectious Diseases.

HONG KONG – Novartis AG was cited during the recent 2020 KoNECT-MOHW-MFDS International Conference as an example of a biopharma firm staying ahead of the artificial intelligence curve. During this week’s 2020 Bioplus Interphex Korea conference, Won Kim, head of innovation at Novartis Korea, described some of the firm’s latest forays into AI, including negotiations with potential partners to develop an AI image analysis solution for retinal diseases.

An independent analysis of studies of Nucleix Ltd.’s Bladder Epicheck demonstrate high diagnostic accuracy and performance in monitoring for disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC).

PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).

Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.

Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.

Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.

TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue.