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FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

The Pharma Data

Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use. The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. Today, the U.S.

Genome 52
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8 Frequently Asked Questions About Genetic Testing in Clinical Trials

Worldwide Clinical Trials

genotyping for known variants vs sequencing only vs sequencing and concurrent deletion/duplication analysis), and whether the interpretation of the genetic testing results may have changed over time. Why is the turnaround time for whole-genome sequencing and whole-exome sequencing (WES/WGS) longer than a single-gene or panel test?

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Biorepositories as a Guiding Resource for Research & Drug Discovery

XTalks

The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Genuity Science focuses on population genomics as a tool to derive novel biological insights through partnerships with industry-leading pharmaceutical and biotech companies.

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Top 30 New Medical Devices of 2024

XTalks

The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers. Illumina says TruSight Oncology Comprehensive is the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims.

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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

These are, in my view, the most valid comparisons, particularly in inherited diseases where the genotype is obviously the same in each individual patient, and as a consequence, the difference in phenotype after gene therapy is a true difference,” he adds. As a result, there are several EU regulations and directives to follow.

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NIH 2023 Data Management and Sharing Policy: What you Need to Know

Advarra

For example, the Genomic Data Sharing Policy applies to NIH-funded research generating large-scale human or non-human genomic data. If another applicable policy has more detailed expectations than what the DMS policy has, organizations should follow those expectations in addition to the DMS policy.