NEW YORK (GenomeWeb) – Navican, a wholly-owned spinout of Intermountain Healthcare, is gearing up to bring a range of cancer genomic testing services to community care providers who are finding it difficult to make sense of lengthy test reports and complex mutational profiles.
Intermountain launched a precision oncology program in 2013, within which the Utah-based healthcare system has been offering all advanced cancer patients the chance to have their cancer profiled on a 96-gene panel it performs internally using Illumina's MiSeq. Since then, more than 700 patients have gotten genomically profiled. Based on the molecular characteristics identified by such testing and the expertise of Intermountain's molecular tumor board, a number of patients have been able to get treatments targeting those features or placed into a clinical trial.
Recently, Lincoln Nadauld, director of cancer genomics at Intermountain, led a study comparing 36 patients who got targeted treatments within its precision oncology program between July 2013 and January 2015 against 36 historical controls who received standard chemotherapy or best supportive care over five years. The researchers reported recently in the Journal of Oncology Practice that patients who received targeted drugs guided by genomic test results had average progression-free survival of 22.9 weeks compared to 12 weeks in the control cohort.
By bringing cancer genomic profiling and related services to the cancer community outside of Intermountain, Navican is hoping to similarly improve outcomes for the approximately 470,000 stage IV cancer patients in the US. The name — a combination of the words "navigation" and "cancer" with an "I" at the center representing the individual — is a reminder that cancer care and precision medicine are ultimately about the patient, CEO Ingo Chakravarty explained to GenomeWeb.
"When we do studies, when we do research, sometimes we get hung up on the statistically meaningful end[point] and power," said Chakravarty, who joined Intermountain in June and worked with Nadauld to launch Navican last week. "But if it's about cancer, Lincoln and I share a belief that it comes down to a single individual."
In addition to next-generation sequencing genomic profiling services, Navican will also provide community oncologists the benefit of a molecular tumor board, assist with procuring drugs they recommend, identify clinical trials that might be right for the patient, and help make the case to payors that they should reimburse for testing. The company will enter a market currently dominated by Foundation Medicine and becoming increasingly crowded with other players, such as Caris Life Sciences and Cancer Genetics.
Chakravarty believes that Navican's affiliation with Intermountain, a recognized name in community oncology and an early precision medicine adopter, will help differentiate it from competitors in the space. Navican expects to market to oncology groups as well as independent hospital groups and academic medical centers that may want to outsource genomic profiling services. The startup has started some of these discussions and will focus on inking customer contracts over the six to 12 months.
One of Navican's key offerings will be a molecular tumor board that sifts through the lengthy genetic testing report for a patient and provides the doctor advice on how to proceed in the care pathway based on available evidence. "It's pretty important for community oncologists to weed out the noise of genomic reports, which are fairly academic when you look at them," Chakravarty said.
Reports from cancer profiling services can be hefty, sometimes as long as 30 pages, and testing usually implicates more than one mutation in the patient's disease. But the physicians who use Navican's services can participate in the tumor board's discussions about their patients' cases. Navican hasn't yet announced who will be on its tumor board, but Nadauld told GenomeWeb that it will include those with experience applying genomics in the academic and community care settings.
Navican's services will aim to acheive two things: using genomics to improve cancer patients' outcomes and doing it in a cost-effective way. With regard to the latter goal, Intermountain's study published in the Journal of Oncology Practice also looked at the cost of a precision oncology approach compared to the standard of care.
The researchers found that the charges per week for patients in the study were comparable — $4,665 per patient in the precision care arm versus $5,000 for controls. However, the average total cost per patient — including cost of treatment, associated radiology and lab work, toxicity, and sequencing — was around $92,000 in the precision care arm compared to $41,000 for those in the standard care arm, reflecting the higher cost of targeted therapy. However, the per-week costs were similar between the arms because there were fewer toxicities, emergency room visits, and hospital admissions among those who received targeted treatment.
Nadauld is planning to track overall survival and healthcare costs from the time patients entered the study until death. Similarly, Navican will also study the impact of its profiling service on patients' outcomes and costs, data points payors want to see for coverage and payment.
Chakravarty was encouraged by the fact that the Centers for Medicare & Medicaid Services recently issued final pricing for several gene sequencing and algorithm based assays that were higher than the rates the agency had previously proposed. Nonetheless, companies providing genomic profiling services are facing a difficult reimbursement environment, and Navican has prepared for this.
"While reimbursement specifically on the Medicare side is challenging, it can't get worse," Chakravarty said. As such, Navican is planning to test between 40,000 and 50,000 cancer patients over the next five years but has also "baked in" revenue losses due to expectations of "not getting paid" during that time.
In its last quarterly earnings call, for example, Foundation Medicine reported increased volumes of more than 10,200 tests, but its clinical testing revenues declined year over year and the firm experienced a small decrease in average payment for reimbursed tests. As a result, the company said it would work to improve the reimbursement prospects for its tests by submitting its FoundationOne NGS panel for parallel review by the US Food and Drug Administration and CMS; working with local Medicare contractors; and opening a lab in Germany to take advantage of recently updated reimbursement codes.
"Certain things will just take time because the industry has to develop data to convince payors that coverage in certain situations makes sense," Chakravarty said.
Meanwhile, Navican will peg the price of its services to a comparable level to what other companies are charging for their comprehensive genomic profiling tests. Foundation Medicine's FoundationOne and FoundationOne Heme, for example, are list priced at $5,800 and $7,200, respectively.
Through 2017, Navican will operate out of Intermountain's facilities in St. George, Utah, but in 2018, the company hopes to have a standalone service lab in Salt Lake City. According to Chakravarty, Navican is also planning to launch more proprietary cancer assays next year based on research using Intermountain's repository of 4.3 million patient samples with outcomes data.