Genetron Holdings Ltd., a Beijing-based precision oncology company, has gained breakthrough device designation status from the U.S. FDA for its blood-based, next-generation sequencing test for the early detection of hepatocellular carcinoma (HCC). The test, called HCCscreen, is intended for individuals at high risk for HCC due to chronic hepatitis B virus infection or liver cirrhosis.

The Medicare clinical lab fee schedule (CLFS) in the U.S. has gone through some twists and convolutions in connection with the rate reset effort, but the suite of expensive, high-end tests is another source of spending concern. The Medicare Payment Advisory Commission (MedPAC) examined that question recently and is considering several possible solutions. Among these are a fixed-rate deflation metric from a starting price point and bundling with a provider’s bundled payment program, two possible solutions that each carry their own set of headaches.

The Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia) has partnered with Thermo Fisher Scientific Inc. to speed molecular profiling in two major studies. The project now uses Waltham, Mass.-based Thermo Fisher’s Ion Torrent Genexus system and Oncomine Precision assay as the sole system for conducting next-generation sequencing (NGS) to improve personalization of therapeutic approaches and better understand drug resistance in non-small-cell lung cancer (NSCLS).

Omnivision Technologies Inc. has developed the first all-in-one RGB-infrared image sensor designed for medical use. The OHO2A1S sensor offers simultaneous white-light RGB and infrared monochrome captures in one complementary metal oxide semiconductor sensor, enabling endoscopes used in oncology to be produced with just one sensor, reducing the size, cost and heat output of the devices.

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).