Molecular diagnostics uses human saliva, tissue, blood, feces, urine, and other samples to detect disease-related markers and provides experimental diagnostic results for medical professionals in disease prevention, screening, diagnosis, stratification, prognosis, and efficacy monitoring.

The US Food and Drug Administration said Tuesday that it plans to reclassify several types of qualitative and quantitative hepatitis B virus (HBV) tests as moderate risk Class II devices from their current classification as high-risk Class III devices.

Challenge Works said Wednesday that it has awarded an £8 million prize to Sweden's Sysmex Astrego for its development of a point-of-care urinary tract infection test that delivers antibiotic susceptibility information in 45 minutes.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of 35 new wet-lab tested digital PCR Microbial DNA Detection Assays for its digital PCR (dPCR) platform QIAcuity, significantly enhancing its offerings in the field of microbial research. The new assays are available on QIAGEN’s comprehensive research platform GeneGlobe and are designed to target a wide range of pathogens responsible for tropical diseases, sexually transmitted infections (STIs) and urinary tract infections (UTIs), further solidifying QIAGEN's position as a leader in microbial detection and analysis.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAseq xHYB Mycobacterium tuberculosis Panel for research use, a new tool in the fight against tuberculosis (TB), the world’s leading infectious disease killer.

The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.

The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.

DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.

Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing.

Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.