German pharmaceutical firm Bayer has partnered with Roche’s molecular information company Foundation Medicine to develop and commercialise a next-generation sequencing (NGS) based companion diagnostics to treat cancer.
NGS-based companion diagnostic tests are designed to unlock molecular information from an individual patient’s tumour genome in order to guide treatment decisions for the disease.
The deal covers several of Bayer’s drug candidates and approved therapies in oncology, along with the portfolio of Foundation Medicine’s tests, including FoundationOne CDx.
FoundationOne CDx is the first FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. It is intended to inform appropriate therapies for patients and help clinicians understand results with evidence of resistance, based on the individual genomic profile of each patient’s cancer.
Initially, Bayer and Foundation Medicine will work towards a companion diagnostic for the pharmaceutical company’s TRK inhibitor Vitrakvi (larotrectinib), which is approved to treat patients having TRK fusion cancer across all solid tumours.
The drug holds US regulatory approval for both adult and paediatric solid tumour patients with a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion and without a known acquired resistance mutation.
It can be used in patients who are metastatic or where surgical resection may cause severe morbidity, and have no satisfactory alternative therapies or have progressed after treatment.
The objective is to improve broad patient access to comprehensive genomic testing in line with Bayer’s commitment to precision medicine.
Bayer Oncology strategic business unit head Robert LaCaze said: “We are excited to collaborate with Foundation Medicine to develop new companion diagnostics and provide tools to move to a more personalised treatment approach.
“The development of a companion diagnostic for Vitrakvi, and our broader collaboration with Foundation Medicine, is an important step forward toward expanding access to testing and identifying the right treatment options for patients with cancer.”
The partners did not divulge the financial terms of the agreement.