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DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

RNA 165
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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97
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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management.

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Osimertinib Resistance and EGFR Mutations in NSCLC Treatment

Bioengineer

Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation. Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation.

Genome 119
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News from AACR 2024: Sunday’s highlights

Drug Discovery World

Jakob Nikolas Kather, Professor of clinical artificial intelligence at Technical University Dresden in Germany, then discussed how AI applications can be used to derive prognostic and predictive information from routine pathology slides.

In-Vivo 52
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Could CRISPR cure HIV? US biotech Excision raises $60m to find out

pharmaphorum

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. Once someone is infected with HIV it stays with them for life thanks to the retrovirus’s ability to inject its DNA code into the host.

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Personalized Blood Test Detecting ctDNA Can Help Predict Lung Cancer Relapse

XTalks

Cancerous cells and tumors release small fragments of DNA into the bloodstream called circulating tumour DNA (ctDNA). The researchers at the Cancer Research UK Cambridge Institute published this data from the LUng cancer CIrculating tumour DNA (LUCID) study in the journal Annals of Oncology. Photo source: Inivata.

DNA 105