[Multibilly]

New NGS MRD test approved by FDA

by Multibilly on Fri Oct 05, 2018 8:45 am

The FDA approved the first MRD (minimal residual disease) test that uses NGS (next-generation sequencing, which is basically fast and deep profiling of the DNA in cells).

NGS MRD-testing is already approved by the NCCN (National Comprehensive Cancer Network), so this should make it easier and faster for insurance companies to approve this test. The test has the ability to detect myeloma cells in the range of 10**-4 to 10**-6 (i.e. it can detect a single myeloma cell in a total population of plasma cells that is between 10,0000 and 1,000,000 cells), depending on the quantity of the cells in the the bone marrow sample that is submitted.

It looks like one has to send a bone marrow sample into the company's lab for processing. So, it's not like a hospital or other facility can run the assay themselves.

"FDA Authorizes First Next Generation Sequencing-Based Test To Detect Very Low Levels Of Remaining Cancer Cells In Patients With Acute Lymphoblastic Leukemia Or Multiple Myeloma," FDA press release, Sep 28, 2018