The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
Ngenebio Co. Ltd. launched a precision diagnostic panel called Oncoaccupanel RNA in South Korea Oct. 29 as a test to detect oncogenic fusion genes commonly found in solid tumors.
Illumina Inc. released Connected Insights in a beta version for the U.S., following its commercial release in other selected countries. Connected Insights, an assay-agnostic, cloud-based software designed to streamline interpretation and reporting across next-generation sequencing (NGS) types, was initially developed for somatic oncology applications, the system will shortly also support whole genome sequencing for rare diseases.
The largest study to date assessing the use of cell-free DNA (cfDNA) analysis to detect cancer in advance of symptoms has completed enrollment of 140,000 healthy volunteers. The study, being run in the U.K. National Health Service (NHS) by the charity Cancer Research UK (CRUK) and cfDNA diagnostics specialist Grail Inc., is using Grail’s Galleri test to look for cancer-specific methylation patterns in blood.
Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
Sophia Genetics SA and Realm Idx Inc. established a collaboration for co-development of new genomic applications and their commercialization. The companies hope to expand next-generation sequencing research and multimodal data streams to improve cancer diagnostics and treatment outcomes.
Fapon Biotech Inc. expanded its presence in the global next-generation sequencing (NGS) market by acquiring all of the shares in U.S. firm Sequlite Genomics US Inc. With the acquisition, the Dongguan, China-based Fapon Biotech will manage Sequlite’s product development and business operation.
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
