The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.

Owkin announced on Tuesday that it entered into a collaboration with MSD — known as Merck in the US and Canada — to develop and commercialize microsatellite instability high (MSI-H) diagnostics for four types of cancer.

Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.

The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years.

Euroimmun, a Revvity company, and Xpedite Diagnostics have partnered to offer DNA extraction protocols for point-of-care diagnostics.

Today, Illumina, Inc. (NASDAQ: ILMN) announced that the company will divest GRAIL.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Canadian diagnostics firm MedMira on Wednesday said it has secured US Food and Drug Administration 510(k) clearance for the HIV-2 claim that will be used in its rapid antigen tests for HIV-1/2 detection.

Liquid biopsy firm SeekIn said Friday that it has entered into a strategic collaboration with Oncolnv, a fully-owned affiliate of Inspire2Live to expand the global accessibility of the firm's menu of cancer detection tests.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have signed an agreement for the mutual supply of reagent raw materials owned by both companies (“the Agreement”). The Agreement is based on a basic agreement on business collaboration in the field of immunoassay*1 which the two companies signed in October 2023.

Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement.

Two recent Parkinson’s announcements suggest a new biomarker test panel coming, as well as cell culture systems for studying Parkinson’s in the laboratory.

Alveo Technologies said Wednesday that it has struck 19 agreements for the distribution of its point-of-care molecular diagnostic products throughout Europe, Africa, and the Middle East.a