The university will use the technology to screen blood samples for certain clinically actionable mutations in non-small cell lung cancer patients.
The partners will use a $5M NCI grant to add seven biomarkers to an EGFR electrochemical assay for non-small-cell lung-carcinoma.
In data presented at the ESMO annual meeting, the test showed some ability to distinguish between patients who responded to nivolumab and those who did not.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
Using deep learning, researchers attempted to classify non-small lung cancer subtypes and predict lung adenocarcinoma mutations from histopathology slides.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
According to a study author, the findings indicate the test could be useful for assessing indeterminate lung lesions, but clinical utility data is still needed.
While the company has historically marketed the test's ability to predict patient drug response, it has more recently focused on its prognostic power.
Funds will support projects aimed at earlier identification of patients who can benefit from treatment.