NEW YORK (GenomeWeb) – NantHealth is gearing up to roll out a comprehensive genomics cancer test, and the firm said it has already inked a coverage deal with a private payor.
The test, GPS Cancer, will launch in March and include tumor and normal whole-genome sequencing, tumor transcriptome sequencing, and proteomics, Patrick Soon-Shiong, founder of NantHealth, which is a subsidiary of NantWorks, told GenomeWeb at the JP Morgan Healthcare conference in San Francisco earlier this month.
Independence BlueCross has agreed to reimburse for the test for patients with rare cancers, tumors in children, metastatic cancer of unknown primary, primary brain cancer, triple negative breast cancer, and metastatic cancer where standard therapies have been exhausted. Both NantHealth and Independence Blue Cross declined to disclose specific coverage details, such as the price of the test, the percentage insurance will cover, and the patient's share of the cost.
Don Liss, vice president of clinical programs and policy at Independence Blue Cross, told GenomeWeb that the company decided to reimburse for the test because it is so comprehensive. "It may replace or substitute for other tests we would normally cover, which factored into our thinking," he said. Cost was another factor, he added, and Liss said the company determined that the price was within a "reasonable range" and could potentially help "avoid downstream costs" by enabling physicians to select the appropriate therapy immediately and avoid drugs that are not likely to be effective.
Although NantHealth has not yet published a clinical validation study of the GPS Cancer test, Liss said that Independence Blue Cross has been in conversations with NantHealth for "quite a long time," and after learning about the test "made a decision that it was a reasonable way to balance our commitment to coverage for state-of-the-art treatment without covering services that were unreasonable or not clinically relevant."
Furthermore, Liss added that at least in the short term, the payor would "not be covering other similar tests." Longer term, he said the firm is keeping its eye on liquid biopsy technologies.
Soon-Shiong said that NantHealth decided to develop such a comprehensive test, as opposed to a smaller panel or one that focused only on DNA, because of the heterogeneous nature of cancer. "Unless you measure everything, you don't get the full picture of a patient," he said.
While NantHealth's GPS Cancer test will be the most comprehensive tumor profiling test on the market, it's unclear how it will compete against Foundation Medicine's FoundationOne and FoundationOne Heme tests. Foundation ran more than 32,000 tests in 2015, although it has struggled to obtain consistent and timely reimbursement for its tests.
Molecular Health also offers an NGS-based tumor profiling test, recently rebranded as Engineus, that evaluates more than 600 genes, and Caris Life Sciences offers tumor profiling using a variety of technologies including immunohistochemistry, NGS, and FISH. Caris recently launched a network to create guidelines for tumor profiling.
Aside from its GPS Cancer test, NantHealth is also embarking on a clinical trial with a goal of sequencing 100,000 patients across 20 different tumor types, Soon-Shiong said. The trial will launch this year, potentially as early as the spring, he said. Ultimately 20,000 of those sequenced will end up in a clinical trial for a drug that matches their genomic alterations, Soon-Shiong said.
Patients who enroll in the Qualitative Integrative Lifelong Trial (QUILT) will be stratified across their anatomical tumor types as well as by their stage of cancer. They will then be placed into various arms of a clinical trial testing targeted therapies or immunotherapies against standard of care. Therapies will be chosen based on the results of the GPS Cancer test, Soon-Shiong said.
Pharmaceutical and biotechnology companies have agreed to make more than 60 immunotherapy, targeted therapy, and chemotherapeutic agents available for use in the trial, Soon-Shiong said.
One major focus of the trial will be on immunotherapies, he said. After receiving the GPS Cancer test, patients will be randomized into either the standard-of-care arm or an arm with a "protocol uniquely designed to maximize the immune system of the patient," Soon-Shiong said.
Immunotherapy is not expected to be as effective in patients who have already received extensive chemotherapy, since chemotherapy effectively "wipes out the immune system." he said. "We believe we've been going down the wrong path by giving the maximum tolerated dose of chemotherapy," he added.
Instead, Soon-Shiong suggested chemotherapy should be used more sparingly. In addition, the GPS Cancer test will be used to identify markers of resistance for various chemotherapy drugs.
The trial is somewhat similar to the National Cancer Institute's MATCH basket trial, which is using a next-generation sequencing-based test to stratify patients into clinical trials of targeted therapies.
However, QUILT is different in that it will sequence patients' entire genomes and transcriptomes, while the NCI-MATCH trial is using a targeted panel. Although more patients than expected have enrolled into the NCI-MATCH, not many matches have yet been made.
Soon-Shiong noted that there are significant differences between the two trials. The QUILT trial will be a variety of different clinical trials, "all of which have various [drug] combinations that are being tested," as opposed to NCI-MATCH, which is mostly focusing on single targeted agents added to standard therapy, he said.
In QUILT, "patients will be assessed up front for eligibility across all the trials, as opposed to using assessment to assign patients to a specific arm." This is a key difference, he added, because the criteria for determining trial arm may not rely on the presence or absence of one marker, like a PIK3CA mutation, but instead, "it could include a series of molecular markers and signatures that can prioritize trials based on their likelihood a patient will respond."