FDA Approves Oncomine Dx Target Test as a Companion Diagnostic for Ivosidenib in IDH1+ Cholangiocarcinoma

Oncomine Dx Target Test is now approved by the FDA as a companion diagnostic for patients with IDH1-mutant cholangiocarcinoma who may be candidates for treatment with ivosidenib.

A pre-market approval has been granted to ThermoFisher Scientific’s Oncomine Dx Target Test, which will act as a companion diagnostic to identify patients with IDH1-mutant cholangiocarcinoma who may be eligible to receive ivosidenib (Tibsovo), according to a press release from ThermoFisher Scientific.1

Single-agent ivosidenib was approved by the FDA on August 25, 2021 for the treatment of adult patients with IDH1-positive cholangiocarcinoma, becoming the first approved therapy for this patient population.2 The agent also has an indication in newly diagnosed IDH1-positive acute myeloid leukemia for patients who are aged 75 years or older or who aren’t eligible for treatment with chemotherapy. Ivosidenib’s indication in cholangiocarcinoma was based on the results of the phase 3 ClarIDHy trial (NCT02989857).3

Findings from the trial identified a statistically significant improvement in progression-free survival (PFS) for those who were treated with ivosidenib, including a median PFS of 2.7 months (95% CI, 1.6-4.2) compared with 1.4 months (95% CI, 1.4-1.6) among those treated with placebo (HR, 0.37; 95% CI, 0.25-0.54; P <.001). Additionally, 32% of patients treated with ivosidenib were free from disease progression or death at 6 months, as well as 22% at 12 months.

“Prior to today, patients with IDH1-mutated cholangiocarcinoma did not have an approved targeted therapy treatment option,” Susan Pandya, MD, vice president, clinical development, head of cancer metabolism global development at Servier Pharmaceuticals, said. “The FDA approval of TIBSOVO (ivosidenib tablets) for patients with previously treated IDH1-mutated cholangiocarcinoma is a major milestone for the cholangiocarcinoma community. I'd like to acknowledge and thank all the patients, their families and the investigators and research teams who took part in the ClarIDHy study, as well as Thermo Fisher Scientific for their partnership.”

The next-generation sequencing (NGS)–based test has been found to yield notable and reproducible results in terms of the IDH1 gene that is commonly associated with cholangiocarcinoma. Oncomine Dx Target Test received its first approval in 2017 and currently has indications as a companion diagnostic for 4 targeted therapies in non–small cell lung cancer and 1 for cholangiocarcinoma.

Additionally, an agreement has been struck to develop and commercialize the Oncomine Dx Target Test with the Oncomine Precision Assay in order to identify patients with IDH1/2-positive low-grade glioma who may potentially benefit from treatment with vorasidenib (AG-881). Notably, the Oncomine Precision Assay utilizes the first fully integrated NGS platform that features an automated specimen-to-report workflow that aids in delivering economic results daily, known as the Ion Torrent Genexus System.


  1. FDA approves NGS-based Companion diagnostic for previously treated IDH1-mutated cholangiocarcinoma. News release. Thermo Fisher Scientific. August 25, 2021. Accessed August 26, 2021. https://prn.to/3zmsqtp
  2. Servier announces FDA approval of TIBSOVO (ivosidenib tablets) in IDH1-mutated cholangiocarcinoma. News release. Servier Pharmaceuticals. August 25, 2021. Accessed August 26, 2021. https://bit.ly/3DhHGu7
  3. Zhu AX, Macarulla T, Javle MM, et al. Final results from ClarIDHy, a global, phase III, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation. J Clin Oncol. 2021;39(suppl 3):266. doi:10.1200/JCO.2021.39.3_suppl.266.