Dutch diagnostics firm MRC Holland said Friday that two of its blood-based assays for spinal muscular atrophy (SMA) have been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.

MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).

A transcriptional signature in blood cells called megakaryocytes following vaccination correlates with the strength of an individual's antibody response months later, according to new research.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa; Head Office: Minato-ku, Tokyo), a wholly-owned subsidiary of H.U. Group Holdings, Inc. (Chairman, President and Group CEO: Shigekazu Takeuchi; Head Office: Minato-ku, Tokyo), and Eisai Co., Ltd. (Representative Corporate Officer and CEO: Haruo Naito; Head Office: Bunkyo-ku, Tokyo; hereinafter "Eisai") announced today that they have entered into a memorandum of understanding for the joint research and social implementation of novel blood-based biomarkers in the field of neurodegenerative diseases.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Babson Diagnostics, a science-first health care technology company, today announced an expansion of fingertip blood collection and testing technologies for use by U.S. health systems and other large provider networks in settings like urgent cares, doctor offices and other ambulatory care settings.

Sunbird Bio, a biotechnology company developing proprietary blood-based technologies to improve diagnosis and treatment of neurological disorders and early-stage cancer, announced new data demonstrating that the company’s blood-biomarker alpha synuclein (α-synuclein) signatures accurately detect the aggregation of α-synuclein in the brain from a simple blood draw. Results from the study, which will be shared in a poster presentation (#116) on October 31 at the Clinical Trials on Alzheimer’s Disease (CTAD) international conference, demonstrate that Sunbird’s technology could provide blood-based diagnosis of multiple neurodegenerative diseases, including Parkinson’s disease, with high accuracy.

Massachusetts and Singapore-based biotechnology company Sunbird Bio has raised $14m to advance the clinical development of its blood-based diagnostic platform for neurological disorders and early-stage cancer.

bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® VITAMIN B12 TOTAL, an automated quantitative test for use on the VIDAS® immunoassay instruments, for the measurement of total Vitamin B12 concentration in human serum or plasma.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know® Syphilis Test, the first over-the-counter blood test granted market authorization by the U.S. Food & Drug Administration (FDA) that can be performed by both physicians and patients.