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Category: Biomarker


Biomarker, Innovation

Reveal Genomics launches HER2+ breast cancer diagnostics trial

June 19, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

Blood Test for Alzheimer’s on the Horizon: ALZpath Licenses pTau217 Antibody to Roche

June 10, 2024

Via: HitConsultant

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. […]


Biomarker, Innovation

Radiomics research identifies new imaging markers in laryngeal cancer

May 16, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

Breast cancer mammogram screenings should start at age 40 instead of 50, says health task force

April 30, 2024

Via: Fox News

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 […]


Biomarker, Innovation

BD to advance bloodstream infections testing in Poland

March 15, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

UK MFT’s blood test helps determine effectiveness of breast cancer drug

March 14, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

FDA grants clearance for Hologic’s cervical cancer screening system

February 2, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

US researchers initiate study to improve pancreatic cancer detection

January 30, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

Cognito starts biomarker substudy in Alzheimer’s device trial

January 23, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

National Health Service launches new ‘blood matching’ genetic test

January 22, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

These COVID Symptoms Are Red Flags That You Need Medical Attention

January 12, 2024

Via: HuffPost

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 […]


Biomarker, Innovation

Geneseeq scores FDA breakthrough designation for cancer detection device

January 4, 2024

Via: Medical Device Network

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) […]


Biomarker, Innovation

Daxor seeks US FDA approval for blood volume analyser 

January 3, 2024

Via: Medical Device Network

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 […]


Biomarker, Innovation

Co-Dx seeks FDA emergency use authorization for Covid-19 test

December 28, 2023

Via: Medical Device Network

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 […]


Biomarker, Innovation

IPHA secures funds from Exact Sciences to improve cancer screening rates

December 11, 2023

Via: Medical Device Network

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 […]


Biomarker, Innovation

Alzheimer’s blood test could hit the market in early 2024, researchers say

December 5, 2023

Via: Fox News

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 […]


Biomarker, Innovation

Balancing regulation and innovation in laboratory-developed tests

December 1, 2023

Via: Medical Device Network

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 […]


Biomarker, Innovation

New lung cancer screening guidelines increase eligibility for high-risk patients: Should you be screened?

November 2, 2023

Via: Fox News

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 […]


Biomarker, Innovation

Upfront Diagnostics conducts final trial phase for POC stroke test

October 30, 2023

Via: Medical Device Network

Upfront Diagnostics has embarked on the final phase of clinical trials in UK hospitals evaluating the use of its point-of-care rapid blood test for stroke. The clinical study is being led by the Newcastle University Stroke Research Group in the […]


Biomarker, Innovation

The Future of Biomarker-Based Therapy for Mental Disorder Care

October 26, 2023

Via: HitConsultant

We are living in a mental health epidemic. An estimated 26 percent of Americans ages 18 and older – about one in four adults – suffer from a diagnosable mental disorder in a given year. Among mental disorders, cases of […]