Natera announces use of Signatera MRD test in TREAT ctDNA trial
Signatera is a personalised, tumour-informed test intended for patients earlier diagnosed with cancer. Credit: Tatiana from Pixabay. Natera has announced the use of its Signatera molecular residual disease (MRD) test in a breast cancer trial, TREAT ctDNA, which will assess oral endocrine monotherapy elacestrant (Orserdu). Signatera is a personalised, tumour-informed test intended for patients earlier […]
C2N’s Precivity blood biomarker test shows promise in Alzheimer’s screening
The study evaluated 1,080 baseline plasma samples from the participants who were recruited and screened for enrolment into the Phase III Leqembi trial. Image Credit: Buravleva stock / Shutterstock. C2N Diagnostics’ study results show that blood biomarkers included in the Precivity blood test help increase the accuracy of amyloid positron emission tomography (PET) classification in […]
Deep Bio and CancerX bring AI to cancer diagnostics and prognosis
The CancerX initiative was launched earlier this year, part of the White House Cancer Moonshot program from US president Joe Biden and the first lady, which aims to prevent more than 4 million cancer deaths by 2047. Credit: Andrea Izzotti/Shutterstock South Korea-based artificial intelligence (AI) healthcare company Deep Bio is working with CancerX on an […]
Further Group partners with cancer clinical trial matcher Massive Bio
The ability to integrate AI into the recruitment process can speed up the identification of suitable cohorts and alert patients to suitable trials. Image credit: Shutterstock/Zubada. Serious illness insurance solution provider Further Group has partnered with Massive Bio to increase patient access to clinical trials. Massive Bio’s platform uses artificial intelligence (AI) to match patients […]
eCOA roadmap: Five key steps to patient-focused drug development
Earlier this year, the FDA released its fourth and final guidance on the incorporation of the patient’s voice in medical product development and regulatory decision-making. With a focus on the successful implementation of clinical outcome assessments (COAs), the US Food and Drug Administration’s (FDA) strategy sought to provide clinical trial organisers with the guidance required […]
What does Biden’s executive order mean for worldwide AI regulation?
The US executive order sends a strong message globally that it is time to move towards AI regulation. Credit: Ascannio via Shutterstock. On October 30, 2023, the Biden administration released the most comprehensive set of rules and guidelines surrounding AI regulation the US has ever seen. The executive order highlights the US sentiment towards AI, […]
What in the world has happened since COP27?
After COP27 the European Union introduced a new plan. Credit: Alexandros Michailidis via Shutterstock. The world is currently at an environmental crisis point with climate records falling monthly, sea levels continuing to rise, and many companies’ net zero targets continuing to be pushed back as COP27 drifts into memory. In an attempt to get a […]
M8 to market Futura’s erectile dysfunction gel in more countries
Approved in the US and Europe as an over-the-counter erectile dysfunction treatment, Eroxon works by an evaporative mode of action, leading to smooth muscle relaxation. Image credit: Shutterstock/Drazen Zigic. M8 Pharmaceuticals will supply Futura Medical’s erectile dysfunction (ED) gel to more countries in Central and South America after the two companies expanded their partnership. UK-based […]
Veracyte and Illumina partner to develop IVD tests
The companies will create molecular tests as decentralised IVD tests on Illumina’s NextSeq 550Dx NGS instrument. Credit: Testalize.me on Unsplash. Veracyte and Illumina have signed a multi-year agreement for the development of molecular tests as decentralised in vitro diagnostic (IVD) tests. Under the agreement, the companies will develop and provide the tests as decentralised IVD […]
Alucent receives IDE approval from FDA for AlucentNVS study
The study will evaluate the technology to enhance the maturation of arteriovenous fistulas in haemodialysis patients. Credit: Tyler Olson / Shutterstock.com. Alucent Biomedical has announced plans to commence a clinical trial of its AlucentNVS technology in the US. The decision comes after the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) […]