Roche granted FDA Breakthrough Device Designation for pTau217 blood test
Supporting earlier Alzheimer's disease diagnosis
Supporting earlier Alzheimer's disease diagnosis
Smartphone-sized laboratory – Sepsis IVD grade test based on cutting-edge BioMEMS technology is a joint development objective
The analyzer promises to provide a cost-effective, comprehensive, and reliable solution for rapid point-of-care testing
This is the first four-in-one nucleic acid test for arbovirus screening
Point-of-care HIV diagnostic testing for infants and early detection of HIV infections
The cobas Malaria test is the first FDA-approved molecular test to screen US blood donors for malaria
Clinicians can now get results at the patient's bedside, making the test accessible at urgent care clinics and other healthcare settings
PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States, delivering results up to three times faster than core lab testing
The device promises rapid discrimination between benign and malignant epithelial ovarian cysts within 15 minutes
The respiratory/sore throat (R/ST) panel receives Dual 510(k) clearance and CLIA-waiver approval
New device rapidly isolates blood plasma for diagnostics and precision medicine
Cologuard Plus was evaluated against an independent fecal immunochemical test, which it significantly outperformed
The Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test aids in the detection of HPV-driven cancer
Study shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90%
Collaboration aims to expand optimal genetic testing for individual diseases
Portuguese researchers, INESC TEC, and the IMP Diagnostics Molecular & Anatomic Pathology laboratory, focus on improving the prototype that uses AI as a complementary tool when diagnosing colon and rectal biopsies
A new test diagnoses patients with melioidosis within hours, rather than days, meaning they can receive the correct antibiotics faster
The partnership focuses on development, manufacturing and clinical adoption of neurodegenerative disease assays
New Aptiva® APS IgG and APS IgM reagents enable early diagnosis of Antiphospholipid Syndrome in hard-to-diagnose autoimmune disease
Through a combination of advanced imaging and novel artificial intelligence, latest diagnostic system for cervical cancer screening can help more accurately detect disease, improve workflow and enhance patient care
The Selux PBC Separator, part of the Next Generation Phenotyping (NGP) System, makes this the only FDA cleared, single-platform technology capable of delivering rapid AST results for both positive blood culture and isolated colonies
David Wells, CEO of the IBMS, discusses the Institute’s plans to ensure the future of biomedical science careers
Sysmex Corporation announces that it has entered a strategic alliance agreement with CellaVision
The beta thalassemia test could help couples make informed reproductive choices, ensure appropriate maternal care, and facilitate diagnosis in infants
New study finds that persistent COVID-19 infections are surprisingly common, with around one to three in every 100 infections lasting a month or longer