The study's goal is to measure the success rate of SkylineDx's multiple myeloma test in a real-world setting compared to the hospital's current standard.
The IVD test will adjust for isatuximab-induced interference in immunofixation electrophoresis tests, which can mislead clinicians in interpreting patient response.
The first phase of the study to evaluate Telo Genomics' telomere analytics as a prognostic solution for multiple myeloma is expected to launch in Q1 2020.
Amgen's latest deal with a pharma company will see its clonoSeq assay used for minimal residual disease testing in a clinical trial for venetoclax.
The immune sequencing firm is working on kit-ifying its two existing tests, as well as developing a second clinical test and expanding the label for clonoSeq.
The UK company plans to launch a CE-IVD version of the test in 2021 and anticipates launch of an FDA-cleared test shortly thereafter.
Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.
In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.
Currently marketed for research use by Biofluidica, the test's microfluidic channels use specific cancer antibodies to detect capture circulating tumor cells.
The test measures the multiple myeloma marker M protein and could prove more sensitive and less susceptible to interferences than existing assays.