Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.

FDA plans public workshop on ctDNA tests

By staff writers

February 14, 2020 -- The U.S. Food and Drug Administration (FDA) is planning to hold a public workshop on March 9 on the development of circulating tumor DNA (ctDNA) tests for cancer screening.

The workshop will explore clinical, scientific, and regulatory challenges associated with the development of ctDNA-based cancer screening tests. Also, stakeholders will discuss the study designs needed to show the safety, effectiveness, benefits, and risks of these tests.

Those interested must register with the FDA by 4 p.m. on March 2. Registrations will be accepted on a first-come, first-served basis. The deadline for written comments on the topic is April 6.

Sysmex liquid biopsy tracks response in early breast cancer
The SafeSeq personalized liquid biopsy platform is helpful in gauging response to treatment in early-stage breast cancer patients prior to surgery, and...
Machine learning, tumor DNA testing a winning combo in colon cancer
A new machine-learning platform helped identify patients with colorectal cancer and predict disease severity with high accuracy in a study of circulating...
Liquid biopsy boosts the odds in triple-negative breast cancer
Circulating tumor DNA test results were significantly associated with disease-free survival in women with early triple-negative breast cancer in a phase...
Foundation, Natera join to develop ctDNA assays
Foundation Medicine and Natera are joining forces to develop and commercialize personalized circulating tumor DNA (ctDNA) monitoring assays.
Natera touts liquid biopsy in bladder cancer
Results from Natera's prospective study validating its Signatera circulating tumor DNA (ctDNA) test in urothelial bladder cancer were published online...

Copyright © 2020

Last Updated np 2/14/2020 12:43:52 PM