Category: Biomarker

July 9, 2024

Artificial intelligence (AI) is proving to be an invaluable tool across the medical device industry, from diagnosis to treatment. AI’s primary contribution to cancer detection lies in its ability to analyse vast amounts of data swiftly and accurately, while traditional […]

June 26, 2024

Today (25 June) is HIV Testing Day, a day in the US to recognise and address the ongoing disparities related to human immunodeficiency virus (HIV) infection, the importance of knowing your status, and learning about HIV prevention and treatment. This […]

June 19, 2024

Spanish biotech start-up, Reveal Genomics, has announced the launch of a trial evaluating the clinical feasibility of its HER2DX genomic test designed for the diagnosis of HER2+ early-stage breast cancer. The Barcelona-based firm announced the prospective trial (NCT06446882) in collaboration […]

June 10, 2024

pTau217 is a protein biomarker crucial for detecting and tracking Alzheimer’s progression in a simple blood test. This offers a significant advantage over traditional methods like PET scans or cerebrospinal fluid (CSF) testing, which are expensive, invasive, and less accessible. […]

May 16, 2024

Aresearch team at Newcastle University in the UK and Newcastle Upon Tyne Hospitals NHS Foundation Trust will initiate a 250-patient study after research showed how AI can improve the treatment and outcomes of laryngeal cancer. Amar Rajgor and his team […]

April 30, 2024

Women should get mammograms every other year starting at age 40, according to updated recommendations from the U.S. Preventive Services Task Force (USPSTF). This is a significant change from previous guidelines, which said women should begin biennial mammograms at age […]

March 15, 2024

Becton, Dickinson and Company (BD) has partnered with Poland’s non-governmental non-profit organisation The Great Orchestra of Christmas Charity (GOCC) to expand testing for bloodstream infections (BSIs) and sepsis management in the country. The collaboration aims to provide more than 150 […]

March 14, 2024

Manchester University NHS Foundation Trust (MFT) in the UK has announced that its blood test could benefit thousands of women eligible for preventative breast cancer drugs. This highly sensitive hormone test can determine the effectiveness of anastrozole, a drug recommended […]

February 2, 2024

The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening. This system is claimed to be the first FDA-cleared digital cytology platform that […]

January 30, 2024

Researchers at OU Health Stephenson Cancer Center in Oklahoma, US, are initiating a study that could transform pancreatic cancer detection using MSOT imaging. This new imaging technique, combined with a specially designed contrast agent, has the potential to identify cancer […]

January 23, 2024

Cognito Therapeutics has enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation device in Alzheimer’s disease patients. The HOPE study (NCT05637801) is assessing the efficacy of Cognitio’s GammaSense Stimulation system in subjects with […]

January 22, 2024

The National Health Service (NHS) in the UK has introduced a ‘blood matching’ genetic test, marking a global first in personalised healthcare for patients with sickle cell disorder and thalassaemia. This new blood group genotyping test is expected to benefit […]

January 12, 2024

When you have a COVID-19 infection, you’re told to isolate and stay away from others until you’re better. But while many folks do improve at home thanks to a combination of medication, rest, hydration and time, others require additional medical […]

January 4, 2024

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq. CanScan was built using Geneseeq’s highly sensitive MERCURY multi-omics technology. The solution uses low-depth whole-genome sequencing (WGS) […]

January 3, 2024

Daxor Corporation is seeking approval from the US Food and Drug Administration (FDA) for its next-generation blood volume analyser, Daxor BVA. Daxor BVA is designed for rapid, simple, and bedside patient care. The company submitted to the FDA through the […]

December 28, 2023

Molecular diagnostics company Co-Diagnostics (Co-Dx) has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument. Co-Dx’s submission for review by the FDA includes the PCR […]

December 11, 2023

The Illinois Public Health Association (IPHA) in the US has received grant funding from cancer screening and diagnostic tests provider Exact Sciences to improve colorectal cancer screening rates. The funds will be used to support screening and provide more healthcare […]

December 5, 2023

Could a simple blood test detect Alzheimer’s disease years before symptoms appear? New research from Resonant, a Utah biotech company that develops diagnostic tests for neurodegenerative diseases, suggests it may be possible. Researchers said its new test achieved 100% accuracy […]

December 1, 2023

The landscape of laboratory-developed tests (LDTs) is facing a significant regulatory shift as the US Food and Drug Administration (FDA) proposes to regulate them as medical devices. The new proposed rule published in October 2023 states the FDA’s intention to […]

November 2, 2023

The American Cancer Society (ACS) has announced new guidelines for lung cancer screenings. Published in the ACS journal “CA: A Cancer Journal for Clinicians” on Wednesday, the advisory reconsiders those who are at high risk for developing lung cancer and […]