The $3.95 billion worldwide molecular diagnostic POC testing market is seeing increasing international activity with China becoming a particularly intriguing part of the Asia Pacific region according to The Market and Future Potential for Molecular Point of Care, published by Kalorama Information.

Spectrum Solutions announced the U.S. Food and Drug Administration (FDA) has granted 510(k) Class II clearance to the SDNA Saliva Collection Device as a microbial nucleic acid storage and stabilization device.

Becton Dickinson announced that its BD Onclarity human papillomavirus virus test has been approved by the US Food and Drug Administration for use with the Hologic ThinPrep Pap test.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Xpert Mpox test from molecular diagnostics company Cepheid.

On February 7 2023, RocGene's independently developed Archimed Mini 16 Medical Fluorescence Quantitative PCR Instrument obtained the Class III Medical Device Registration Certificate by the National Medical Products Administration.

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Anavasi Diagnostics' molecular point-of-care AscencioDx COVID-19 Test Kit.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Natera, Inc., a global leader in cell-free DNA testing, today launched an early access program for clinical use of FoundationOne®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay.

PerkinElmer said Monday it had secured US Food and Drug Administration authorization to market an assay for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.

Italian diagnostics firm DiaSorin said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Simplexa Congenital CMV Direct kit for the detection of cytomegalovirus (CMV) DNA.

Molecular testing company Predicine said on Tuesday that its blood and urine cell-free DNA (cfDNA) assay, PredicineCare, has secured a CE-IVD mark.