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Intermountain Gets National Stage, Myriad Adds Tumor Profiling Panel With Combined Test Offering

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NEW YORK – Intermountain Health's recent collaboration with Myriad Genetics to develop a combined somatic/germline genetic test report for cancer patients will provide the regional healthcare system's precision oncology offerings a national stage. 

At the same time, Myriad, which is best known for providing germline genetic testing for assessing cancer risk, will round out its precision oncology offerings by adding a large tumor profiling test via Intermountain. The partners are hoping that their collaboration will ultimately benefit oncologists by providing a more streamlined experience ordering genomic tests that can inform the care of their cancer patients.

Earlier this month, Intermountain and Myriad, both headquartered in Salt Lake City, said they would develop a combined offering that includes three next-generation sequencing tests: Myriad's myRisk Hereditary Cancer test and myChoice CDx, and Intermountain's TheraMap tumor profiling test. MyRisk analyzes blood and saliva samples and gauges germline alterations in 35 genes associated with increased risk for eight cancers; myChoice CDx analyzes ovarian cancer patients' tumor tissue for homologous recombination repair deficiency (HRD) and predicts their ability to respond to PARP inhibitors olaparib (AstraZeneca's Lynparza) and niraparib (GlaxoSmithKline's Zejula); and TheraMap analyzes tumor tissue for abnormalities in more than 500 genes and predicts cancer patients' ability to respond to a range of treatments.

The partners are aiming to launch the combined offering in the second half of the year, at which point oncologists around the country will be able to receive results from all three tests in one report.

In a crowded genetic testing market, oncologist often order companion diagnostics, germline testing, and large tumor profiling panels from different labs, and find it difficult to make sense of the results when there are discordant findings, according to Nicole Lambert, president of Myriad Genetic Laboratories and group president of Myriad Oncology. For example, doctors have received reports from NGS-based tumor profiling tests that filtered out or failed to report patients' germline cancer risk mutations. In one study presented at the National Society of Genetic Counselors' annual meeting last year, out of around 200 patients with mostly advanced cancers who had both germline and somatic testing, around a quarter had discordant results.

According to Lambert, a unified report that integrates results from both germline and somatic tests can identify and resolve such discordance, so oncologists aren't left to figure it out on their own. "[Oncologists] are trying to make heads or tails out of this and make the best decision for a patient who may only have one shot to get the right treatment … What do they say to the patient about these different results?" said Lambert. "Our goal with this collaboration was to ease that burden for the patient and the provider and say, 'We can give you all of these different services you're looking for.'"

In deciding to partner with Intermountain, however, Myriad did not take the traditional M&A route to expanding its precision oncology offerings. In contrast, when Invitae, a longtime competitor of Myriad in the germline cancer testing space, decided to venture into tumor profiling and liquid biopsy testing last year, it acquired ArcherDx. Invitae is also working to streamline access to genetic testing for providers, and in recent years has built itself into a one-stop shop for genetic information through numerous acquisitions. 

"The way that precision medicine is moving, it is going to be much more about partnership than acquisition," Lambert said. "This was a good way for us to not just try to bring a laboratory offering in-house, but to have a partner that's providing healthcare, where you can look at outcomes and what's going on across the whole healthcare ecosystem. It's not just about providing a laboratory result."

Myriad chose Intermountain, according to Lambert, because it's a large healthcare provider with roots in the same town that has both a precision medicine program and experience integrating a variety of genetic tests in the workflow of doctors. "Because they are a large hospital system, they really have figured out the most innovative ways to integrate [test results] within [electronic medical records] and to present the results in a way that is most meaningful and useful to clinicians," she said.  

Meanwhile, Intermountain, which serves Utah, Idaho, and Nevada, and operates 24 hospitals and 225 clinics in the region, saw in Myriad a chance to take its precision oncology offerings national. "Myriad has been a leader in the field of genetic testing for many decades and they have national representation," said Lincoln Nadauld, chief of precision health and genomics at Intermountain. Partnering with Myriad, he added, enables Intermountain's precision genomics unit to access a national audience in a way that it couldn't do on its own.

For the past eight years, the health system has been steadily extending more and more precision medicine offerings to its providers and patients. In 2013, Intermountain launched a precision oncology program and began offering in-house NGS tumor profiling to all stage IV cancer patients. Intermountain also has an in-house germline genetic test for inherited cancer syndromes, called Inhera. Through a partnership with Kailos Genetics, Intermountain is establishing pharmacogenomic testing that doctors can use to personalize treatments beyond cancer. On the research side, the health system is enrolling patients in the prospective PATHFINDER study to evaluate the early cancer detection capabilities of Grail's liquid biopsy test and has partnered with Decode Genetics to whole-genome sequence 500,000 patients and search for new genotype-phenotype associations. 

As Intermountain grew its precision medicine program, Nadauld and others in the precision genomics unit recognized that community oncologists around the country were lacking the testing and related support services that providers in its healthcare system had access to. In 2016, hoping to address this need, Nadauld's team spun out a company, called Navican, through which it would provide community oncologists genomic profiling services, access to experts through a molecular tumor board, assistance with matching cancer patients to clinical trials, and support with the reimbursement process. 

However, as Intermountain's continued investments in precision oncology became more widely recognized, its leadership team decided 18 months ago to integrate Navican back into its precision genomics unit. "We realized that we actually have some advantages in representing our somatic testing as an organization rather than as a separate standalone for-profit entity," Nadauld said. "We brought Navican and the TheraMap test back into Intermountain precision genomics. That's all one consolidated team and that simplifies things for us." Nadauld clarified that although providers within Intermountain have access to a molecular tumor board and other support services, those are not currently part of the offering being developed with Myriad.

Still, the collaboration with Myriad allows for the integration of germline testing with somatic testing, something Nadauld's team has been working on establishing within Intermountain amid mounting evidence that germline assessments can inform the management of patients, even if they don't have a strong family history of cancer. In the fall of 2018, the health system decided to launch a 500-patient trial to test out the feasibility of offering germline testing on a bigger scale and collect data on its impact. After that pilot, Nadauld had hoped to roll out germline testing to all newly diagnosed cancer patients within Intermountain using Inhera, a large, in-house NGS panel.

Researchers enrolled around 300 patients in that trial, and then, due to the COVID-19 pandemic, Intermountain had to suspend all research studies. "We just reopened enrollment about a month ago," Nadauld said. "I anticipate that by the end of the year we'll have finished that study and we'll be offering germline testing to all newly diagnosed cancer patients. That's on our roadmap for this year."

Once the integrated test report with Myriad is launched, oncologists outside of Intermountain will also have the opportunity to order germline genetic risk analysis alongside somatic testing. Doctors at Intermountain will still be able to order its in-house germline panel. "The rationale is that in patients with advanced cancer, we can use this combined somatic and germline test in partnership with Myriad to identify immediate therapeutic implications," Nadauld said. "Our much larger germline Inhera test that is 105 genes is still available for providers who have a patient with early-stage cancer where they suspect some inherited cancer syndrome, for example, or for genetic counselors who want a more comprehensive test." 

Before Myriad and Intermountain can launch their unified report, a lot of details have to be worked out, according to Nadauld, including how data will be shared between the two entities, billing for the individual test components, as well as marketing and branding. Another consideration will be how to manage patients' tissue for analysis on myChoice CDx and for TheraMap, which will have to be split and shipped to two different CLIA labs for analysis. 

"We're now in the process of unpacking the logistics with Intermountain and understanding what's the best solution," Lambert said. "How can we get the fastest turnaround times and the best service for our providers depending on who does what."

Once the unified report is developed, it may make it easier for doctors to order testing but it remains to be seen how insurers will react to the consolidated offering, especially since payors don't routinely cover paired germline/somatic testing and some have stringent prior authorization policies for ensuring that an ordered genetic test fits their coverage criteria. Labs performing tumor profiling have previously noted that payors are reluctant to pay for germline analysis to confirm findings suggestive of a clinically significant inherited alternation. 

As individual tests, MyChoice CDx and myRisk have good coverage from payors, according to Lambert. TheraMap has undergone review through MolDx and has local Medicare coverage, and the panel has "good payment" rates from commercial payors, according to Nadauld.

"Coverage is very good across all of these tests," particularly when oncologists order them for patients with difficult-to-treat tumors, such as pancreatic and prostate cancer, Lambert said. "Patient access and coverage will be excellent if physicians determine that a patient is appropriate for any combination of these tests. I don't think reimbursement will be their biggest issue."