Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.

Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. Under the agreement, Seegene and Werfen will set up a NewCo in Spain, Werfen-Seegene, upon the conclusion of mandatory government approvals anticipated by the first half of 2025.

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

Agilent Technologies Inc. (NYSE: A) today announced a new strategic partnership with the National University of Singapore (NUS), acting through the Yong Loo Lin School of Medicine (NUS Medicine), to establish the NUS-Agilent Center of Excellence (CoE) in Cell Metabolism. This scientific collaboration will advance cardiovascular and metabolic disease translational research over the next four years.

An international team has tracked the protein changes that occur in cerebrospinal fluid (CSF) during disease progression in individuals with autosomal dominant forms of Alzheimer's disease.

Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.

Following the passage of continuing resolutions (CR) by the US Senate and the House of Representatives this week, lab test reimbursement cuts and price reporting requirements called for under the Protecting Access to Medicare Act (PAMA) are likely to be delayed one year.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).

PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

Cepheid announced today an important partnership with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust and Imperial College London to combat antimicrobial resistance.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations.

At present, the upstream raw materials of biochemical reagents mainly rely on imports. For the long-term development of the industry, the preparation technology of raw materials must be mastered.

Introduction 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 di..

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.

New TAGS (Temperature-Activated Generation of Signal) technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800.