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The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
PacBio will try to take the Sequel II to the clinic in China with the help of Berry Genomics and is open to partnerships globally, including with Illumina.
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
The company's +RNAinsight test, a combined DNA and RNA genetic test for hereditary cancer syndromes, was launched in October.
AbbVie researchers validated and extended a previous study to find different types of genetic evidence have varying influences on approval prospects.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
Illumina and PacBio wrote that the agency "has failed to establish that Illumina's short-read systems and PacBio's native long-read systems compete."
A new study finds that three dimensional facial scans may be able to aid in diagnosing rare genetic diseases.
The Lancet and the New England Journal of Medicine have retracted two COVID-19 papers due to concerns about the data used in their analyses.
Lawmakers plan to introduce a bill that aims to prevent the theft of US-funded research, according to the Wall Street Journal.
In Science this week: analysis of ancient Caribbean islanders' genomes suggests at least three waves of migration into the region, DNA barcoding of microbial spores, and more.