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 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).
Following days of speculation, Illumina Inc. said today it will acquire liquid biopsy startup Grail Inc. for $8 billion in cash and stock, bringing back into the fold a company it spun out in 2016. The deal gives Illumina a major stake in the race the race to develop a less-invasive way to diagnose cancer. Since spinning out, Grail has raised nearly $2 billion from big-name investors with promises of a blood test for early cancer detection and is hoping to introduce its liquid biopsy as a laboratory-developed test (LTD) as early as next year.
Next-generation sequencing may help provide clinicians with a speedier answer as to the identity of the second pathogen, a service that may prove critical to suppressing the fatality rate in this and in future pandemics, according to Robert Schlaberg, chief medical officer of IDbyDNA Inc., of Salt Lake City.
The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.
Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.
Strata Oncology Inc. has inked an agreement with newcomer Elevation Oncology to ramp up patient identification and enrollment for the latter’s phase II CRESTONE study evaluating the use of seribantumab in patients with recurrent, locally advanced or metastatic solid tumors of any origin that have a neuregulin-1 (NRG1) gene fusion.
Thermo Fisher Scientific has joined forces with First Genetics JCS to commercialize next-generation sequencing (NGS) diagnostics in Russia. The agreement allows Moscow-based First Genetics to bring its F-Genetics NGS system and in vitro diagnostic assays for reproductive health testing to Russian labs.
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.