The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.
The initial FDA approval of Thermo Fisher's NGS panel test for personalizing cancer treatment may allow rapid expansion to new indications.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
The expanded indication makes it a first-line option for metastatic non-small cell lung cancer patients with ALK rearrangements.
The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
The business was acquired by two private investment groups and a management group led by Prometheus Laboratories' former CEO.
Under the deal, Novartis will access patients who have used Perthera's Precision Cancer Analysis service, which facilitates molecular profiling of cancers.
Novartis will retain Genoptix's biopharma business, which will be renamed Navigate BioPharma Services.
Thermo Fisher developed the NGS-based multi-marker assay in collaboration with Novartis and Pfizer to match lung cancer patients with targeted drugs.
The companies discussed their plans to change the one-test, one-drug companion diagnostic paradigm at the Personalized and Precision Medicine conference this week.