Top

Category: Biomarker


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 […]


Biomarker, Innovation

Think You Have COVID? Here’s The Best Way To Test Yourself Now.

October 18, 2023

Via: HuffPost

It’s that time of year again. Upper respiratory infections like respiratory syncytial virus (RSV), influenza and COVID are rising — and we’re only just getting started. The signs and symptoms of these infections can be quite similar and include anything […]


Biomarker, Innovation

KHB scores EU certification for HIV antibody diagnostic test

October 12, 2023

Via: Medical Device Network

Shanghai Kehua Bio-engineering (KHB) has obtained an EU class D in vitro diagnostic regulation certification for rapid tests covering the company’s diagnostic kit for HIV (1/2) antibody (Colloidal Gold) V2. KHB’s HIV diagnostic kit tests for human immunodeficiency virus (HIV)-1 […]


Biomarker, Innovation

HLTH 2023: Urgency needed to address neurodegenerative disease space

October 9, 2023

Via: Medical Device Network

As the prevalence of neurodegenerative diseases rapidly rises, researchers at the ongoing HLTH 2023 conference highlighted how biomarker development is urgently needed for treatment breakthroughs to occur. In the United States, as many as 6.2 million people may have Alzheimer’s […]


Biomarker, Innovation

A Blood Test That Screens for Cancer: Does It Do More Harm Than Good?

August 11, 2023

Via: Kaiser Health News

By summer 2021, Gilbert Milam Jr. was living a good life. A nationally renowned rapper who performs under the name Berner, Milam was also enjoying the global expansion of Cookies, a brand of cannabis products and clothing that he co-founded […]


Biomarker, Innovation

Researchers identify plasma biomarkers of mental health risk in adolescents

August 1, 2023

Via: ScienceDaily

An estimated 10-20% of adolescents struggle with mental health conditions, with the majority remaining undiagnosed and untreated. New, early indicators of mental health problems are urgently needed, as they could revolutionize early detection and, in the future, the prevention of […]


Biomarker, Innovation

Alzheimer’s Drug Discovery Foundation backs new diagnostic biomarker test

July 18, 2023

Via: Medical Device Network

Hot on the heels of positive results for Eli Lilly’s Alzheimer’s disease (AD) drug donanemab, a new blood-based test could soon be hitting the AD clinical space. The Alzheimer’s Drug Discovery Foundation (ADDF) has seen the clinical promise in ALZpath’s […]