NEW YORK – AnHeart Therapeutics and Roche subsidiary Foundation Medicine announced Thursday that they have entered a strategic collaboration to develop and garner regulatory approval for Foundation's comprehensive genomic profiling tests as companion diagnostics for AnHeart's investigational ROS1 inhibitor taletrectinib in the US.
The drug is currently being evaluated for the treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer in two Phase II trials, TRUST-I and TRUST-II, AnHeart Therapeutics said in a statement. Foundation Medicine's tissue- and liquid-based tests, FoundationOne CDx and FoundationOne Liquid CDx, will be developed as companion diagnostics for the drug.
The next-generation sequencing-based tests analyze more than 300 genes using either DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens or cell-free DNA isolated from plasma.
"High-quality genomic profiling tests are critical to inform treatment decisions and have become foundational for treating NSCLC as more precision therapies targeting specific genetic alterations, such as ROS1, are being developed," Troy Schurr, Foundation's chief biopharma business officer, said in a statement. "We look forward to working with AnHeart to deliver swift access to this investigational precision therapy if approved and ultimately to help more patients living with this disease."
Earlier this year, AnHeart announced a collaboration with Guardant Health to develop the Guardant360 CDx and Guardant360 TissueNext assays as companion diagnostics for the use of taletrectinib in adults with advanced or metastatic NSCLC in the US and Europe.