The state-of-the-art assay is processed on the Company’s random-access iSYSTM or i10 TM instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining superior accuracy and reliability. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.

Revvity, Inc. (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This clearance modifies the one Roche received on June 14, 2024 for Roche Digital Pathology Dx, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, and now adds the VENTANA DP 600 slide scanner.

Danaher Diagnostics LLC and Danaher Ventures LLC, two subsidiaries of Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced today that they have formed an investment partnership with Innovaccer Inc., a leading healthcare artificial intelligence (AI) company.

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2024 and preliminary cash balance.

Roche (ROG.S), opens new tab on Wednesday said it planned to complete its purchase of U.S. biopharmaceutical company Poseida Therapeutics (PSTX.O), opens new tab, a specialist in complex immune cell therapies to treat several types of blood cancer.

OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change to the OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has partnered with Genomics England to support the delivery of the Generation Study.

Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett’s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient’s individual risk of progression from Barrett’s esophagus (BE) to esophageal cancer.

Leica Biosystems and YZY Medical Forge Strategic Partnership Recently, Wuhan YZY Medical Science & Technology ("YZY Medical") and Leica Biosystems (Shanghai) Co., Ltd. ("Leica Biosystem..

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.

Anbio Biotechnology Is Preparing To Launch Its IVD Business

3. Molecular Diagnostic Reagents for Tumor 3.1 Tumor Screening Reagents Colorectal Cancer Screening Test The U.S. Preventive Services Task Force (USPSTF) recommends four types of screening fo..

Original from: 360dx OpGen disclosed on Friday that Nasdaq's listing and hearing review council has affirmed an earlier decision by a Nasdaq hearing panel to delist the company's stock. OpG..