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Category: Biomarker


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 […]


Biomarker, Innovation

Quanterix introduces new blood test for Alzheimer’s diagnosis

July 7, 2023

Via: Medical Device Network

Quanterix has introduced the new biomarker blood test, LucentAD, to facilitate the diagnosis of Alzheimer’s disease (AD) in patients. The test has been designed to help assess patients experiencing cognitive symptoms consistent with the early signs of AD. Healthcare providers […]


Biomarker, Innovation

Artificial intelligence advances cancer diagnostics in the next decade

June 22, 2023

Via: Medical Device Network

In GlobalData’s Clinical Trials Database, there are currently 1,490 active clinical trials for in vitro diagnostics (IVD) devices, where 569 trials are focused on oncology diagnostic devices. Specifically, nine of these trials involve analysis or partial analysis. This month, Mindpeak, […]


Biomarker, Innovation

It’s Time to Get Serious About Incidental Lung Cancer Detection

June 21, 2023

Via: Health IT Answers

Lung cancer is the leading cause of cancer deaths worldwide, with approximately 1.8 million people dying from this disease each year. Most patients are diagnosed after symptoms have appeared and the disease has progressed to an advanced stage (Stage III […]


Biomarker, Innovation

Heligenics launches new genetic test for breast cancer

June 14, 2023

Via: Medical Device Network

Biotech company Heligenics has introduced a new precision genetic test to choose among drugs for the treatment of breast cancer. The new genetic test helps select among three drugs approved by the US Food and Drug Administration (FDA) for breast […]


Biomarker, Innovation

Aspira Women’s Health and DFCI to form ovarian cancer diagnostic test

May 12, 2023

Via: Medical Device Network

Aspira Women’s Health has entered an exclusive licensing deal with the Dana-Farber Cancer Institute (DFCI) to design and develop a new microRNA-based ovarian cancer diagnostic test. The new test will use circulating microRNAs, either alone or along with proteins or […]


Biomarker, Innovation

New breast cancer screening guidelines call for women to start mammograms at age 40

May 9, 2023

Via: Fox News

The U.S. Preventive Services Task Force (USPSTF), based in Rockdale, Maryland, has released a draft of new guidelines for breast cancer screenings, recommending that women begin getting mammograms every other year starting at the age of 40. The new guidelines […]


Biomarker, Innovation

Tempus receives FDA approval for NGS-based test xT CDx

May 2, 2023

Via: Medical Device Network

Tempus has received premarket approval from the US Food and Drug Administration (FDA) for its qualitative next-generation sequencing (NGS)-based in vitro diagnostic device, xT CDx. The xT CDx device is designed to detect substitutions (single nucleotide variants and multi-nucleotide variants), […]


Biomarker, Innovation

Study shows Syn-One Test’s ability to identify alpha-synuclein in skin

April 27, 2023

Via: Medical Device Network

CND Life Sciences has announced that its Syn-One Test was able to identify the pathological form of alpha-synuclein in the skin of more than 95% of patients diagnosed with synucleinopathy in the Synuclein-One study. Synucleinopathies are a group of disorders […]


Biomarker, Innovation

Parkinson’s researchers discover disease biomarker in key breakthrough

April 13, 2023

Via: Fox News

An international group of researchers has discovered a new tool that can reveal a key pathology of Parkinson’s disease in brain and body cells. The identification of the new biomarker, known as abnormal alpha-synuclein, opens a new chapter for research, […]


Biomarker, Innovation

Study shows positive impact of GC Genome’s liquid biopsy in solid tumours

April 10, 2023

Via: Medical Device Network

Genomic diagnostics company GC Genome has announced the results of a study that proved the ability of its liquid biopsy technology to predict radiation therapy (RT) response in solid tumours. The trial showed the feasibility of cell-free DNA (cfDNA) monitoring […]


Biomarker, Innovation

Elypta scoops $1m prize for early cancer detection test

March 29, 2023

Via: Medical Device Network

The Roddenberry Foundation has awarded $1m to Elypta and $500,000 to five finalists for early-stage ventures contributing to United Nations Development Goals. Elypta, a Swedish diagnostic company, aim to provide the first metabolism-based liquid biopsy for early detection of cancer. […]