Thermo Fisher Scientific Inc. is working with Daiichi Sankyo Co. Ltd. to develop a companion diagnostic (CDx) to identify non-small-cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who could be eligible for the Tokyo-based company's cancer drug, Enhertu.
Hong Kong – Vuno Inc. is looking to access more markets after inking a partnership with Japan’s M3 on June 19. The partnership with M3, a medical data platform which is 34% owned by conglomerate Sony Corp., allows Vuno to tap into the Japanese market. The M3-Vuno tie-up aims to encompass all Vuno’s existing products.
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Keeping you up to date on recent developments in diagnostics, including: Border detection algorithm for melanoma; Predicting future suicide risk; Multiracial study gives new diabetes insights; Patient genetic variants linked to wound microbiomes.
Just the name, Strategic National Stockpile (SNS), evokes the image of a huge warehouse, or a series of warehouses spread across the U.S., strategically stocked with all the medical supplies, diagnostics and drugs that will be needed nationwide to respond to any health emergency brought on by terrorists, nuclear attacks, pandemics or other public health hazards. The reality is so much more – and so much less.
Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.
Invitae Corp. (NYSE:NVTA) saw its stock flying high June 22 on the news of its agreement to buy Archerdx Inc., with an eye toward enhancing cancer genetics and precision oncology. Investors appear to approve of the deal, with the company’s stock closing at $27.05, up $8.34 or 44.58%.
China-based precision oncology company Genetron Holdings Ltd. and prenatal molecular testing company Progenity Inc. each successfully priced an IPO. This is just the latest demonstration that molecular diagnostics is gaining real traction when it comes to investment.
PARIS – Stilla Technologies SAS, of Villejuif, France, is supplying a new, cost-effective approach for COVID-19 testing by combining its digital polymerase chain reaction (PCR) technology with the group testing method. “This approach greatly increases testing capacity and meets the highest quality standards,” Rémi Dangla, co-founder and CEO of Stilla Technologies, told BioWorld.
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.”
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