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The BGI Real-Time Fluorescent RT-PCR Kit for detecting SARS-2019-nCoV runs in approximately three hours and can be manufactured in large volumes, the firm has said.
The kit, which is CE marked, is designed to detect the virus' ORF1ab, N, and E genes, and can process 96 samples within two hours.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 15 skipping alterations.
The company has said it expects to be able to perform roughly 10,000 tests a day by the end of this week and roughly 20,000 tests per day by the end of March.
The biomarker-based test determines women whose human papillomavirus infections are most likely to be associated with cervical pre-cancers.
SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.
According to a US Food and Drug Administration webinar yesterday, a lot of IDT test kits has been qualified by CDC and is authorized for purchase.
The single-tube real-time PCR-based test has also received CE marking, according to Seegene, and is now commercially available.
The genotyping test is designed to identify cancer patients with a metabolic disorder that can result in toxicity to a common cancer therapeutic.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.