The U.S. Food and Drug Administration has approved the Oncomine Dx Target Test from Thermo Fisher Scientific Inc. It is the first test of its kind to screen tumor samples for biomarkers associated with multiple cancer therapies, in this case for non-small-cell lung cancer (NSCLC). It is expected to enable more rapid evaluation of treatment options for these patients, in days rather than over several weeks.

The test was developed in collaboration with Novartis AG and Pfizer Inc.; some of the first labs to offer it will include Laboratory Corporation of America's Diagnostics and Covance businesses, Neogenomics Laboratories, and Cancer Genetics Inc.

The Carlsbad, Calif.-based company is looking to expand the panel to include indications beyond lung cancer.

Development goals

The companion diagnostic stems from a 2015 development deal with the pair of pharmas. It's now approved to determine the appropriateness of a trio of treatments: a combined therapy of Tafinlar (dabrafenib, Glaxosmithkline plc) and Mekinist (trametinib, Glaxosmithkline plc), Xalkori (crizotinib, Pfizer Inc.) or Iressa (gefitinib, Astrazeneca plc).

Going forward, the Oncomine Dx Target Test is expected to expand into additional marketed drugs as well as therapy candidates that are in development for NSCLC. And beyond that it's slated to form the basis of a universal test that will provide recommendations for cancer treatment regardless of its origin within the body.

"The original goal was to take a panel-based approach to depict various mutations that might be present in the tumor. We started with about 46 actionable mutations with drugs on the market or in development by various pharma companies," Joydeep Goswami, Thermo Fisher president of clinical next-generation sequencing and oncology told BioWorld MedTech. "That initial test could be extended within lung cancer or to other cancers with minimal cost.

The FDA approval for the test is expected to serve as a proof of principle that will help expand the number of pharma partnership deals related to it. The test evaluates 23 genes that are clinically associated with NSCLC with results from the analysis of three of those genes indicating eligibility for one of the three treatments.

Universal test

Along with several other diagnostics companies, including Illumina Inc., Thermo Fisher has been aiming for a universal test that can easily be used for solid tumor patients, regardless of where the cancer originated in the body. In the fall of 2014, Thermo Fisher did a deal with Glaxosmithkline and Pfizer to develop just such a test that could serve as a companion diagnostic across multiple drug programs.

"A universal test is exactly what we have in mind. The task for a universal test is getting specific mutations for specific drugs approved," explained Goswami, noting that this FDA approval is laying the foundation for that expansion. "We expect that as other drugs are validated on the same panel, the FDA will continue to approve them."

"We are in partnerships already with several pharma partners that are testing drugs for lung cancer and extending to other cancers, including colon and breast. Our approach in cancer is that it shouldn't actually matter. Given that it's a molecular disease, the organ of origin shouldn't matter to give doctors a more accurate and holistic view," he continued.

Last month, Thermo Fisher partnered with Agios Pharmaceuticals Inc. around development of a companion diagnostic for a rare bile duct disorder treatment that's in phase III.

"It makes it far easier for companies to prove their drugs on this platform," Goswami noted of the FDA approval. "We have some partnerships that are undisclosed and several in late stages of discussion. Part of that was people waiting for this approval. It de-risks the platform and this will accelerate that activity."

Patient benefits

For NSCLC patients, the Oncomine Dx Target Test is expected to mean easier, faster and more comprehensive testing.

"This is a huge step forward for patients. They don't need to go through multiple rounds of testing to figure out which genes are mutated and which drugs are the right ones to take," said Goswami. "Right now, oncologists often have to guess what the mutation of the tumor is, usually going with the most common mutation, but that's only found 15 percent of the time. So, the treatment may not work or may not work for very long. They may have to go through a round of treatment before they find out they were probably better suited to a different kind of treatment."

He continued, "Now, the right treatment can be provided to the patient from the start rather than waiting for weeks to get sequential testing done. These patients are already a late stages, IIIb or IV, so they don't have much time left. Getting them to the right therapy and quickly is a massive step for these patients."

In addition, the availability of the new test via any lab in a hospital, if it has been adopted, is expected to make this sort of testing more widely available to patients who may have previously only had limited PCR-based testing of a couple of genes.

The test also requires only a very small tumor sample, unlike some other genetic testing, which is crucial particularly in this very sick NSCLC patient population where a tumor biopsy is very difficult to conduct.

Thermo Fisher has just started having conversations around reimbursement and declined to disclose pricing information on the test. But given that some of these drugs can run in excess of $100,000 for a single course of treatment, Goswami expects that they might appeal to payers.

He noted that in that context the cost of the test is insignificant; existing IVD tests that must be conducted in a centralized lab run north of $3,500.

Thermo Fisher is conducting studies to compare the ability of its test to detect relevant mutations versus other tests that are available, which are in the process of being published. But Goswami said that they initial results indicate that the comparisons should be "quite favorable."