MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).

Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.

Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.

BGI Genomics said on Friday that its multiplexed test for SARS-CoV-2, influenza A, and influenza B is now included in the Australian Register of Therapeutic Goods.

Recently, Sansure and Singlera jointly established Jiangsu Yang Shengyuan Biotechnology Co., Ltd. with the registered capital of 10 million CNY at Yangzhou City.

Illumina and Myriad Genetics said on Thursday that they have expanded their strategic partnership on homologous recombination deficiency (HRD) testing.

Biocartis said Thursday that it has secured US Food and Drug Administration 510(k) clearance for a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients.

By the end of 2022, there were 1,033,000 medical and health institutions in China, including 37,000 hospitals. The medical and health institutions in China possessed 9.75 million beds, of which hospitals possessed 7.66 million and township health centers had 1.45 million.

QIAGEN N.V. announced the launch of the new QIAseq Platform Partnership program and the first partnership with medical data-analysis provider SOPHiA GENETICSTM that will bring together its QIAseq reagent technology for next-generation sequencing with the SOPHiA DDMTM digital analytics platform.

Agilent Technologies reported after the close of the market that its fiscal first quarter revenues rose 5 percent year over year with gains across all end markets.

On February 26, Mindray and the First Affiliated Hospital of Guangxi Medical University held a signing ceremony at Mindray headquarters in Shenzhen and signed a strategic cooperation agreement.

Natera reported after the close of market Tuesday year-over-year revenue gains of approximately 26 percent for the fourth quarter of 2022 and 31 percent for the full year.

Roche announced that it has expanded its partnership with the US Centers for Disease Control and Prevention to improve HIV and tuberculosis prevention, testing, and treatment.

On February 24, China National Medical Device Co., Ltd. and GE Healthcare China signed an agreement in Beijing to establish a medical equipment joint venture in China to meet the growing demand of China's medical and health market.

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.

CareDx reported after the close of the market on Monday year-over-year revenue gains of 4 percent for the fourth quarter of 2022 and 9 percent for the full year.

POCT is a clinical test that is performed next to the patient and sampled on-site for immediate analysis. Simplicity and convenience are always the most important features of POCT.

The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2.

Chembio Diagnostics has obtained a CLIA waiver from the US Food and Drug Administration for its DPP HIV-Syphilis System, the firm announced on Friday.