Blueprint Medicines has tapped Thermo Fisher Scientific to develop a companion diagnostic for its cancer candidate BLU-667. The deal will see Thermo Fisher validate and seek approval for a test to identify RET fusions in non-small cell lung cancer (NSCLC) patients.
Thermo Fisher is using its Oncomine Dx Target Test as the basis for the companion diagnostic. The next-generation sequencing test won FDA approval in the detection of BRAF, ROS1 and EGFR gene mutations in NSCLC patients in June, clearing it for use in the identification of patients eligible for treatment with drugs from AstraZeneca, Novartis and Pfizer.
Now, Thermo Fisher will work to expand the test to detect RET fusions. These fusions are rare but play a key role in driving cancer in a subset of NSCLC patients. Blueprint thinks BLU-667, a kinase RET inhibitor, can help these patients. Thermo Fisher’s job is to ensure investigators and, if the drug comes to market, physicians can quickly find out which patients have the fusion.
The first job is to use the companion diagnostic to aid enrollment in a phase 1 trial of BLU-667. That trial got underway earlier this year and is due to deliver initial data in the first half of 2018.
If Thermo Fisher successfully validates the RET component of the Oncomine Dx Target Test, it will seek an expanded label from the FDA through a supplemental premarket approval application. The terms of the agreement with Blueprint give Thermo Fisher responsibility for seeking this and other approvals, plus rights to commercialize the test globally.
News of the agreement comes months after Thermo Fisher entered into a similar relationship with Agios Pharmaceuticals. That deal tasked Thermo Fisher with expanding its diagnostic test to cover IDH1 mutations, which are seen in patients with a rare bile duct cancer.
The overarching goal is to create a multigene companion diagnostic. Equipped with such a test, doctors could simultaneously check whether their patients have any of a range of therapeutically important mutations, instead of ordering multiple single-biomarker analyses.