AnHeart Therapeutics and Foundation Medicine have agreed to the development and regulatory approval of the latter’s FoundationOne CDx and FoundationOne Liquid CDx, as companion diagnostics (CDx) for the former’s ROS1 inhibitor taletrectinib in the US.

Taletrectinib is an investigational oral, potent, brain-penetrant, selective, next-generation ROS1 inhibitor.

It is currently being assessed to treat ROS1-positive advanced or metastatic non-small cell lung cancer (NSCLC). Taletrectinib has also secured breakthrough therapy designation from the US Food and Drug Administration (FDA).

FoundationOne CDx and FoundationOne Liquid CDx are the company’s tissue-based and liquid-based comprehensive genomic profiling tests.

AnHeart US chief medical officer Lian Li said: “We are excited to collaborate with Foundation Medicine on the development of both tissue- and liquid-based companion diagnostics to help identify patients who may benefit from taletrectinib.

“Foundation Medicine’s high-quality testing portfolio and proven regulatory expertise make them a preferred partner for us as we work to bring this promising next-generation therapy to patients living with ROS1-positive NSCLC.”

The FDA-approved diagnostic test suite from Foundation Medicine provides doctors with alternatives for tissue- and blood-based testing to identify genetic changes that inform individualised treatment plans.

FoundationOne CDx is a next-generation sequencing and prescription-based in vitro diagnostic device.

It is intended for the detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements.

FoundationOne Liquid CDx is a qualitative next-generation sequencing-based in vitro diagnostic test.

It is designed to use targeted high throughput hybridisation-based capture technology to analyse 324 genes using circulating cell-free DNA (cfDNA).

Foundation Medicine chief biopharma business officer Troy Schurr said: “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.

“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.”