NMPA
Bionano Genomics' Chinese Partner Nabs NMPA Approval for Saphyr OGM Platform
With the approval, Bionano's OEM partner Hangzhou Diagens Biotechnology can now sell the platform directly to hospitals and clinical labs in China.
Burning Rock, Dizal Get Chinese Approval for Lung Cancer CDx
The test, approved by Chinese regulators in early 2022, is designed for the detection of multiple mutation statuses for nine genes.
Bionano Genomics Inks OEM Deal With Chinese Partner to Commercialize Clinical Cytogenetics Workflow
Hangzhou Diagens Biotechnology has received China NMPA approval for Bionano's reagents and plans to register the Saphyr instrument for use in reproductive health.
Dinfectome Nabs China NMPA Approval for Benchtop NGS Sequencer
The Chinese molecular diagnostics firm said the DIFSeq-200 platform can achieve a Q30 score of above 85 percent while generating multiple read lengths.
Promega to Develop Microsatellite Instability Companion Diagnostic Kit With GlaxoSmithKline
The IVD kit will be used to identify patients with the MSI biomarker who may be eligible for potential treatment with GSK's Jemperli (dostarlimab-gxly).