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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.

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Sartorius upscales gene therapy prowess with $2.6bn Polyplus acquisition

Pharmaceutical Technology

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. to complete an in-house plasmid DNA facility in Marburg, Germany. “In In February 2023, the mRNA specialist BioNTech invested $43.8m

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Uptick in Clinical Trial Complexity: How Can You Achieve Your Clinical Trial Objectives Faster?

XTalks

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.

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Generating Over a Billion Cells with CRISPR for Next Generation Cell Therapies

XTalks

Viral vectors have traditionally been used in gene editing where the shells of viruses carry the template DNA into cells, but this method has its disadvantages. It is difficult to control where the viral vectors insert genes in the genome, and it is difficult to manufacture large quantities of clinical-grade viral vectors.

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Top 30 New Medical Devices of 2024

XTalks

In a clinical trial, participants demonstrated a 98% success rate after six months post implantation, with arteries widened successfully and no stent fractures observed. The Shield test provides a non-invasive approach to colorectal cancer screening by analyzing blood for key DNA changes linked to cancer. Photo courtesy of BD.

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

Further, some patients are still hesitant to go into the clinic, and the prevalence of misinformation from the pandemic has led to greater concerns about therapies like gene therapies and the impact they fear it will have on their RNA/DNA. Working with a centralized IBC/IRB provider can speed up your process. .

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The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans

Worldwide Clinical Trials

Molecular Biomarkers : Encompass various molecules, such as RNA and metabolites, to reflect the physiological state of the cells and their disease pathways. The analysis of circulating tumor DNA (ctDNA) in a liquid biopsy can also permit genotyping and help monitor the effectiveness of chemotherapy.

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