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Category: Biomarker


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. […]


Biomarker, Innovation

FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

February 27, 2023

Via: Healthcare Dive

Lucira was one of the diagnostic companies that rose to prominence during the pandemic. In November 2020, the California-based company received the first EUA for a fully at-home COVID-19 test. Early the following year, Lucira raised $176 million through an […]


Biomarker, Innovation

Leading innovators in endoscopic biopsy for the medical devices industry

February 3, 2023

Via: Medical Device Network

The medical devices industry continues to be a hotbed of innovation, with activity driven by increased need for homecare, preventative treatments, early diagnosis, reducing patient recovery times and improving outcomes, as well as a growing importance of technologies such as […]


Biomarker, Innovation

Cancer blood test using DNA fragments brings hope for earlier detection, say researchers

January 20, 2023

Via: Fox News

Researchers have developed a new machine-learning model to detect cancers that are in their early stages of disease by examining DNA fragments from cancer cells in the blood. A University of Wisconsin­–Madison research team was able to detect cancer in […]


Biomarker, Innovation

Nectin Therapeutics Raises $25M for Immuno-Oncology Therapies

November 30, 2022

Via: HitConsultant

The company also announced dosing of the first patient in its Phase 1 clinical trial of NTX1088, Nectin’s first-in-class PVR blocker, in cancer patients with locally advanced and metastatic solid tumors. NTX1088 is a first-in-class high affinity monoclonal antibody directed […]


Biomarker, Innovation

FDA grants EUA for Lucira Health’s COVID-19 & Flu Test

November 23, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Lucira Health’s COVID-19 & Flu Test for use in point-of-care settings. The nucleic acid amplification test (NAAT)/molecular test has been developed for the simultaneous rapid in […]


Biomarker, Innovation, Med Tech

Johns Hopkins finds new AI blood test detects liver cancer in study

November 21, 2022

Via: Medical Device Network

Johns Hopkins University School of Medicine in Maryland, US, has announced that a new artificial intelligence (AI)-based blood testing technology was found to detect more than 80% of liver cancers in a study. The new blood test, dubbed DNA evaluation […]


Biomarker, Innovation

Uterine Fibroids Linked To Chemicals Found In Common Products

November 18, 2022

Via: HuffPost

Approximately 80% of reproductive-aged women develop uterine fibroids —non-cancerous tumors that grow in the uterus — yet it’s often unclear what causes them. Scientists have long suspected that genetics play a role, as do hormones, diet and major life stressors. […]