The grant will co-fund a year-long project to validate Biofidelity's chemistry to detect mutations used to guide non-small-cell lung cancer treatment.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
Two KEYNOTE studies showed TMB may have some utility in determining which NSCLC patients should get pembrolizumab, while three others showed no utility.
The team identified six independent DNA methylation blocks that could potentially help to predict the formation of central nervous system metastases in lung cancer.
Results from the CheckMate-227 trial provided evidence for the use of nivolumab and ipilimumab in combination, while the FLAURA study focused on osimertinib.
An interim analysis of the IMpower110 study showed that the drug performed better as a first-line treatment than chemotherapy in these patients.
The drugmaker will present data from the Impower110 trial at an upcoming meeting and submit the data to regulatory authorities.
As labs implement TMB workflows in-house, studies are showing that its is possible to validate assays with cutoff points remaining stable across complex clinical cohorts and in different drug contexts.
Although the FDA has already approved the regimen in this indication after seeing its impact on progression-free survival, the latest data speaks to its impact on survival.
The firms plan to use Thermo Fisher's Oncomine Dx Target test to identify cancer patients with RET alterations who might benefit from Lilly's LOXO-292.