AUG 22, 2013 3:00 PM PDT

Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications

C.E. Credits: CE
Speaker
  • Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, U.S. Food and Drug Administration
    BIOGRAPHY

Abstract
The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform development. With the emergence of novel technologies, the FDA is faced with new regulatory challenges while continuing to apply scientific evidence-based oversight. While there are no broadly accepted standards or methods to analytically validate ultrahigh throughput sequencing tests yet, there are a number of efforts underway, including establishing reference materials to aid in assessing analytical performance. The additional challenge in informed clinical application of sequence information is inadequate knowledge about correlations between genomic variations and their clinical significance. The FDA is proactively working to encourage cross-collaboration in this area. Ultimately, the FDA has to balance public safety concerns with fostering innovation and enabling the translation of emerging technologies that can improve medical care and benefit public health.

Show Resources
You May Also Like
FEB 15, 2023 7:00 AM PST
FEB 15, 2023 7:00 AM PST
Date: February 15, 2023 Time: 7:00am (PST), 10:00pm (EST), 4:00pm (CET) While not all microscopy samples can fluoresce, all can scatter light, and this scattered light can be imaged. This ha...
OCT 12, 2022 9:00 AM PDT
C.E. CREDITS
OCT 12, 2022 9:00 AM PDT
Date: October 12, 2022 Time: 9:00am (PDT), 12:00pm (EDT), 6:00pm (CEST) The microbiome of every food product is incredibly diverse and can include everything from innocuous background flora...
C.E. CREDITS
Date: October 25, 2022 Time: 9:00am (PST), 12:00pm (EST), 6:00pm (CEST) Candida auris is a multi-drug resistant yeast that continues to be a global threat for infection and transmission in h...
NOV 16, 2022 7:00 PM PST
C.E. CREDITS
NOV 16, 2022 7:00 PM PST
Date: November 16, 2022 Time: 2:00pm (AEST) Date: November 17, 2022 7:00pm (PST), 10:00pm (EST), 4:00am (CET) The growth in FDA-approved cell and gene therapy products for the treatment of d...
OCT 11, 2022 8:00 AM PDT
C.E. CREDITS
OCT 11, 2022 8:00 AM PDT
Date: October 11, 2022 Time: 8:00am (PDT), 11:00pm (EDT), 5:00pm (CEST) Multiomic profiling of cell populations at single-cell resolution is revolutionizing scientists’ understanding o...
AUG 17, 2022 10:00 AM PDT
AUG 17, 2022 10:00 AM PDT
DATE: August 17, 2022 TIME: 10:00am PDT, 1:00pm EDT Detection and/or amplification of target DNA sequences by polymerase chain reaction (PCR) is a prevalent method in molecular biology. PCR...
Loading Comments...
Show Resources