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.

Recently, an GDF-15 Chemiluminescence Immunoassay kit of Maccura Biotechnology Co., Ltd. obtained the medical certificate. This kit is the first certified Chemiluminescence Immunoassay kit for growth differentiation factor 15 in China.

General Electric completed the spinoff of its healthcare division on Wednesday morning as GE HealthCare began trading on the Nasdaq exchange under the ticker “GEHC” at $56 per share.

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).

Cytiva and Aurisco have cooperated to build Oligo FlexFactory production line project in Yangzhou. This production base has been invested hundreds of millions of yuan and can reach an annual production capacity of hundreds of kilograms of GMP-level small nucleic acid drugs once established.

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).

Prostatype Genomics said on Monday that it has formed a commercialization alliance for its gene-based prostate cancer test with Swedish genetic testing provider Life Genomics.

Polysciences, Inc., a Pennsylvania-based manufacturer of specialty chemicals for research, IVD and medical device applications, has announced its plan to create a new brand, Kyfora Bio, representing its product offerings to the bioprocessing market.

Alercell said on Wednesday that it is preparing a January launch for Lena Q51, a leukemia diagnostic test that uses DNA sequencing to test for 51 gene mutations.

On January 3, 2023, Shanghai Biotree BIOTECH Co., Ltd., a leading Chinese metabolomics research company, announced the completion of a strategic financing round of CNY 10 Million A+.

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.

Guangzhou MyGene Medical Technology Co., Ltd. announced the completion of several hundred million yuan in Series C financing. This round of financing was led by Efung Capital, the funds will be used for R&D and product registration for the IVD products.

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.