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NEW YORK – The US Food and Drug Administration this week issued final guidance concerning the submission of next-generation sequencing data from resistance assessments performed in the development of antiviral drugs.

The FDA's Division of Antiviral Products independently analyses all resistance studies associated with antiviral drugs "to ensure that the emergence of resistance is carefully characterized and explained in the label," the agency said.

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At a meeting this week, researchers and others discussed the regulatory oversight needed for germline genome editing.

The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.

Researchers report that neutrophil extracellular traps appear to binds gallstones together, according to New Scientist.

In Science this week: approach to infer genotype-by-environment interaction from genetic variants associated with phenotypic variability, and more.

Aug
22
Sponsored by
BC Platforms

This webinar will discuss how the Estonian Biobank, a cohort of more than 165,000 participants, is addressing industry challenges with data management and collaboration in the transition to precision medicine.

Aug
29
Sponsored by
PerkinElmer

This webinar will outline how RUCDR Infinite Biologics, the world's largest university-based biorepository, has implemented workflows and processes to support precision medicine applications.

Sep
18
Sponsored by
Bionano Genomics

This webinar will outline how a team at Radboud University Medical Center is assessing ultra-long read optical mapping on the Bionano Saphyr system to replace classical cytogenetics approaches in routine testing and for the discovery of novel structural variants with potential scientific, prognostic, or therapeutic value that are missed by standard approaches.

Oct
23
Sponsored by
Swift Biosciences

This webinar will illustrate how single-cell methylation sequencing can be applied to gain significant insight into epigenetic heterogeneity in disease states, advancing cancer research discoveries.