Expanding the value for Oncomine Dx

CARLSBAD, Calif.—Thermo Fisher Scientific has signed new agreements with Daiichi Sankyo and Takeda Pharmaceuticals which will enable the expansion of the use of its Oncomine Dx Target Test. The agreements will allow each of the partners to glean more from their clinical trials and drug development programs while also validating additional biomarkers and gene variants on the test. Thermo Fisher will retain the rights for global commercialization of the test, while the partnerships will strengthen its role in enabling increased precision oncology.

The Oncomine Dx Target Test is the first FDA-approved test that can detect multiple gene mutations for non-small cell lung cancer (NSCLC) in a single test from a single tissue sample, simultaneously delivering multiple biomarker results from one sample within four days. It allows simultaneous evaluation of 23 genes clinically associated with NSCLC, three of which are companion diagnostic (CDx) biomarkers for three FDA-approved targeted therapies. In addition to being a CDx to aid in the selection of NSCLC patients for treatment with specific targeted therapies, it is also designed to report on clinically actionable mutations in 46 genes across the most common cancers.

The agreements with Daiichi Sankyo and Takeda Pharmaceuticals are in line with the planned strategy for the Oncomine test. Specifically, the strategy is to expand the test beyond NSCLC by establishing additional partnerships with pharmaceutical companies that wish to leverage the additional genes on the panel, making it more broadly applicable for labs, clinicians and patients.

“This is an attractive option for pharmaceutical companies that have need of a next-generation sequencing-based solution to support their drug development programs,” says Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “By leveraging the additional genes already on the panel, Daiichi Sankyo, Takeda Pharmaceuticals and others can potentially streamline the time associated with their clinical trials and bring their therapies to market. While we have not worked with Daiichi Sankyo or Takeda on companion diagnostics before, the unique advantages and expandable nature of the Oncomine Dx panel prompted the collaboration, and could be a template for more such collaborations between the companies.”

In advance of these agreements, Thermo Fisher has established other supplemental premarket approval programs. The company entered into a CDx agreement with Agios Pharmaceuticals last year to validate the Oncomine Dx test to identify IDH1 mutations in cholangiocarcinoma patients, and with Blueprint Medicines to identify RET fusions in NSCLC. Just this month, they signed an agreement with Spectrum Pharmaceuticals to use the test as a companion diagnostic for Spectrum’s novel pan-HER inhibitor, poziotinib, which is in development for the treatment of NSCLC patients with EGFR and HER2 exon 20 insertion mutations.

“Partnerships such as these allow us to rapidly increase the utility of the panel and drive adoption of the panel in CLIA/ CAP certified labs,” asserts Goswami. “For example, the agreement with Agios Pharmaceuticals is centered on developing and commercializing Oncomine Dx Target Test as a CDx for ivosidenib (AG-120) to identify isocitrate dehydrogenase 1 (IDH1) mutations in cholangiocarcinoma patients. Ivosidenib is an IDH1 inhibitor currently in a Phase 3 trial for the treatment of patients with advanced IDH1m positive cholangiocarcinoma, a rare form of cancer that affects the human bile duct system with a high unmet medical need.”

In March, 2018, Oncomine Dx Target Test was approved for coverage by the Centers for Medicare & Medicaid Services (CMS) as part of the agency’s national coverage determination for next-generation sequencing in-vitro diagnostic tests. Prior to this development, private health insurers had also begun granting coverage of the test for their members, and others continue to follow suit, including many of the country’s largest health insurers, including CIGNA, Aetna, UnitedHealthcare, Independence Blue Cross and Humana. Between the coverage from CMS and commercial payers, Oncomine Dx Target Test is now available to more than 160 million lives in the United States. The test has also been adopted and is offered as a service to oncologists by several national reference laboratories, including Quest Diagnostics, Cancer Genetics Inc., NeoGenomics Laboratories and LabCorp’s Diagnostics and Covance businesses.

“We are extremely pleased with the strong interest and commitment from our pharmaceutical partners who see the value of leveraging the expandability of [the test],” said Goswami. “This unique feature can help expedite their drug development programs so that patients potentially benefit more quickly from the targeted therapies in the development pipeline.”