Keeping you up to date on recent developments in diagnostics, including: Improving sensitivity of COVID-19 tests; Deep learning algorithm helps triage suspected COVID-19 cases; Cancer image analysis tool incorporates HER2 biomarker assay.
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.
HONG KONG – Israel’s Ben-Gurion University of the Negev (BGU) has set up a company to further develop and commercialize its technology into a wearable device for predicting epilepsy-related seizures.
LONDON – French venture capital firm Kurma Partners has announced the first closing at €50 million (US$58.6 million) of its second fund to be wholly devoted to seed and early stage investment in diagnostics. Kurma Diagnostics 2 (KDx2) will be invested in molecular and digital diagnostics technologies being spun out of universities and research centers across Europe, backing a total of 15 companies.
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.
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.
Keeping you up to date on recent developments in diagnostics, including: Brain imaging reveals signs of childhood trauma; Buyer beware for SARS-CoV-2 antibody detection; Tumor-associated cell cluster signal cancer alert.
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.