Genomic and diagnostic testing company Prenetics Global said Tuesday that the US Food and Drug Administration has cleared ACTOnco, a comprehensive genomic profiling test for solid tumors.
Precision BioLogic said Thursday it secured US Food and Drug Administration 510(k) premarket clearance for its Cryocheck Chromogenic Factor IX test for managing hemophilia B.
Foundation Medicine said Wednesday its FoundationOne Liquid CDx test has received approval from the US Food and Drug Administration as a companion diagnostic for Genentech's Rozlytrek (entrectinib).
Liquid biopsy oncology firm Burning Rock said on Tuesday that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for its OverC Multi-Cancer Detection Blood Test (MCDBT).
Roche Diagnostics China and Beijing Hotgene Biotechnology Co., Ltd. have reached a cooperation to jointly launch the novel coronavirus (2019-nCoV) antigenic detection kit on the basis of fully integrating the advantages of technology and resources of both sides.
Visby Medical's respiratory panel test has received Emergency Use Authorization from the US Food and Drug Administration, according to a letter from the agency.
The US Food and Drug Administration has granted Emergency Use Authorization for Becton Dickinson’s monkeypox PCR test.
Roche and Pfizer have launched a collaboration in the U.S. to help those who test positive for COVID-19 find the best resources for the best possible outcomes.
The independently developed "COVID-19 antigen detection kit SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)" by Synthgene Medical Technology was approved by the UK 5-year CTDA certification.
On December 13, COVID-19 specific medicine was available online. The COVID-19 Consultation Clinic at 111, Inc. Internet hospital has begun pre-selling Pfizer's COVID-19 oral antiviral drug Paxlovid (nematovir/ritonavir tablets), priced at CNY 2,980 per box.
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