Signatera MRD test – pro
On MAY 6, U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation for its Signatera test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) in the blood of patients previously diagnosed with certain types of cancer and in combination with certain drugs. On March 24, 2021 /PRNewswire/ Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the US Food and Drug Administration (FDA) has granted two Breakthrough Device Designations (BDDs) covering new intended uses of the Signatera molecular residual disease (MRD) test. These new designations will support the development of Signatera through Phase III clinical trials as a companion diagnostic to two different cancer therapies.
No phase III trials had been performed and no guideline currently recommend this test.
oombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019.
Magbanua M, Brown-Swigart L, Hirst G, et al. Personalized serial circulating tumor DNA (ctDNA) analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 TRIAL. Data presented at spotlight session: San Antonio Breast Cancer Symposium; December 5, 2018. Abstract 1259
Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring. Poster presented at: European Society for Medical Oncology Annual Congress; October 20, 2018; Munich, Germany. Abstract 86P.
Reinert T, Henriksen TV, Rasmussen MH, et al. Serial circulating tumor DNA analysis for detection of residual disease, assessment of adjuvant therapy efficacy and for early recurrence detection in colorectal cancer. Poster presented at: European Society for Medical Oncology Annual Congress; October 21, 2018; Munich, Germany. Abstract 456PD.
ACE BRIEF FOR NEW AND EMERGING
HEALTH TECHNOLOGIES
The Signatera Test for Patients Previously Diagnosed with Cancer
Document Number: HSB-M 04/2022 Date: May 2022