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Category: Biomarker


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. […]


Biomarker, Innovation

Non-Invasive, Precision-Based Approaches for Diagnosis and Treatment of Inflammatory Skin Conditions

November 16, 2022

Via: HitConsultant

Inflammatory skin conditions such as atopic dermatitis, psoriasis, vitiligo, hidradenitis suppurativa and others impact a significant portion of the U.S. population. In fact, nearly half of all visits to primary care physicians include some level of dermatological indication. Many of […]


Biomarker, Innovation

Neonatal monitoring drives innovation for all patients

November 14, 2022

Via: Medical Device Network

Neonatal monitoring allows healthcare providers to track and screen newborns for basic functions, including monitoring temperature, oxygen saturation (SpO₂), blood pressure, heart rate and respiration rate. Higher-end monitors incorporate accessories such as resuscitation systems, intravenous lines for feeding/blood/medication, ventilation, and […]


Biomarker, Innovation

Early detection of lung cancer is essential in curtailing lung cancer mortality

November 14, 2022

Via: Medical Device Network

November is Lung Cancer Awareness Month, a time aimed at raising awareness for the world’s leading cause of cancerous deaths. According to the International Agency for Research on Cancer, the estimated annual mortality due to lung cancer is projected to […]


Biomarker, Innovation

AMPEL rolls out genetic test to predict heart disease in lupus patients

November 7, 2022

Via: Medical Device Network

AMPEL BioSolutions has unveiled a new genetic precision medicine test that can predict heart disease at an early stage in women with lupus. The new CardioGENE lab test also provides decision support for prophylactic therapies. It uses blood samples to […]


Biomarker, Innovation, Research

Enzyre raises funds for haemophilia diagnostic platform development

November 3, 2022

Via: Medical Device Network

Dutch company Enzyre has raised $11.85m (€12m) in a Series A financing round to accelerate the development of its ambulant diagnostic technology platform for haemophilia patients. Led by new investor Oost NL, the financing round also saw participation from Demcon […]


Biomarker, Innovation

Research: Proscia AI Predicts Diagnostic Agreement for Melanoma

November 2, 2022

Via: HitConsultant

Proscia is a software company that is accelerating pathology’s digital transformation to change the way we understand diseases like cancer. Its Concentriq digital pathology platform and powerful AI applications are advancing the 150-year-old standard of research and diagnosis towards a […]


Biomarker, Innovation

QU and UoW researchers develop blood test for osteoarthritis diagnosis

October 28, 2022

Via: Medical Device Network

Researchers at Qatar University (Qu) and University of Warwick (UoW) in the UK have developed a new blood test to diagnose early-stage osteoarthritis. The new test quantifies modified amino acids that are released into the blood from proteins in the […]


Biomarker, Innovation

Roche’s RT-PCR test receives FDA 510(k) clearance

October 25, 2022

Via: Medical Device Network

Roche Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Qualitative PCR test. The new real-time RT-PCR test has been designed for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal […]


Biomarker, Innovation

What To Expect If You Need A Breast Biopsy

October 17, 2022

Via: HuffPost

Millions of people get breast biopsies every year, and yet the ins and outs of the procedure are seldom openly discussed. Breast biopsies help doctors diagnose different types of breast lumps and lesions. If your radiologist can’t immediately rule out […]


Biomarker, Innovation

Male Breast Cancer Is Rare But It Exists. Here Are The Signs.

October 14, 2022

Via: HuffPost

Breast cancer is a condition that’s usually associated with those who are women. The disease occurs in more than 280,000 women in the United States each year and is the topic of study at many research hospitals. But it’s an […]


Biomarker, Innovation

Roche to launch three new SARS-CoV-2 rapid antigen tests

October 13, 2022

Via: Medical Device Network

Roche is set to introduce its three next-generation SARS-CoV-2 rapid antigen tests (‘2.0’) for self-test and professional use in countries that accept the CE Mark. The tests include the SARS-CoV-2 Rapid Antigen Test 2.0, the SARS-CoV-2 Rapid Antigen Test 2.0 […]


Biomarker, Innovation

The One Place You’re Probably Forgetting When You Do A Breast Check

October 5, 2022

Via: HuffPost

Every year, about 264,000 women in the United States are diagnosed with breast cancer. The enormity of this number underscores the importance of understanding your personal risk, abiding by guidelines for screenings and being otherwise on alert for any early […]


Biomarker, Innovation

This Is What A Breast Lump Actually Feels Like

October 3, 2022

Via: HuffPost

In April 2022, Clea Shearer ― co-founder of the popular organization company The Home Edit ― announced that she had breast cancer. The diagnosis came after she discovered a lump in her breast and called multiple doctors to go in […]