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Myriad Genetics Launches New Comprehensive Suite of Cancer Tests With Research Registry

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NEW YORK – Myriad Genetics on Monday officially launched a testing service through which oncologists can simultaneously characterize their patients' inherited genetic risks for cancer and suitability for drugs and clinical trials.

The company has been developing this testing service, dubbed Precise Oncology Solutions, with Intermountain Healthcare for the past year. Through it, doctors can order Myriad's MyRisk Hereditary Cancer Test for assessing patients' inherited risk for eight cancers, as well as MyChoice CDx and BRACAnalysis CDx for identifying patients with BRCA1/2 mutations and other DNA repair deficiencies that make them more likely to respond to PARP inhibitors.

In addition, doctors looking for further personalized treatment options and clinical trial opportunities for their patients can now cast an even wider net by ordering Intermountain's TheraMap — rebranded by Myriad as the Precise Tumor Molecular Profile Test — which sequences more than 500 genes.

Physicians can place a single order for all of these tests through a new online portal that will serve as a "central hub" for tracking the status of ordered tests and receiving results. The Salt Lake City-based firm even gave some forethought to how it can help oncologists understand reports, apply the findings in patient care, and advance research.

In parallel, Myriad is introducing a registry to share with researchers de-identified, aggregate genomic and clinical data from patients tested through the Precise program. It will also soon provide ordering physicians peer-to-peer support through a molecular tumor board.

"Oncologists really need comprehensive answers for their patients, but they want it in an easy way," Myriad Genetics Chief Medical Officer Thomas Slavin said.

As genomic information becomes increasingly important in cancer care, Myriad isn't the only company that has noticed oncologists want to streamline their test ordering experience. Competitors such as Invitae are also creating a "one-stop shopping" experience so doctors can order from one lab all the genomic tests they need for their cancer patients: germline assessment, tumor profiling, minimal residual disease testing, and even polygenic risk scores.

Ahead of the official launch of Precise, Myriad tested out oncologists' interest as well as any operational kinks through a soft launch. During a call last month to discuss its 2021 financials, Myriad Chief Operating Officer Nicole Lambert highlighted that 82 percent of doctors who ordered the tumor profiling test through this early-access program also ordered MyRisk and MyChoice CDx.

Myriad, which has recently undergone a strategic reorganization of its test pipeline and focus, projected 9 percent to 12 percent top-line organic growth from 2022 to 2024, with its oncology business contributing modestly to revenues, in the range of 2 percent to 3 percent. "We expect this growth will be driven by our entry into the tumor profiling market with Precise Oncology Solutions," Myriad CEO Paul Diaz said during the same earnings call.

Slavin described Precise Oncology Solutions as an offering that brings together Myriad's 25 years of experience in hereditary cancer risk assessment and the tumor profiling expertise at Intermountain, one of the first healthcare systems in the US to make comprehensive genomic profiling a standard part of late-stage cancer patients' care.

Intermountain, meanwhile, also headquartered in Salt Lake City, has the opportunity through Myriad to make its tumor profiling test available beyond the local community it serves to oncologists around the country. When doctors order the tumor profiling test through Precise Oncology Solutions, patients' tissue samples are sent to Myriad, which shuttles them to Intermountain's lab. After tumor sequencing is performed, Intermountain checks for clinically significant discordance with any germline testing, and sends the results to Myriad for reporting to the physician.

In light of its partnership with Myriad and because more Intermountain patients are having their tumors sequenced, the healthcare system has added personnel and sequencing capacity so it can handle six times more samples than it previously could. Howard McLeod, an internationally recognized expert in precision medicine who recently joined Intermountain as executive clinical director of precision health, estimated that the healthcare system's lab can sequence samples in the low hundreds each day, if necessary.

Benefiting patients with gynecologic cancers

With the launch of the Precise service, Myriad has established a platform through which it can continue to add new oncology diagnostic products aimed at personalizing treatment. For example, the company teased at the JP Morgan Healthcare Conference in January that it wants to eventually launch a minimal residual disease test for monitoring patients' circulating tumor DNA for relapse ahead of imaging.

Meanwhile, the tests currently being offered through the Precise service will be particularly useful to doctors managing patients with breast and gynecologic cancers, a setting in which Myriad is already a leading provider of germline testing and companion diagnostics. In the case of BRCA1/2 germline testing, such assessments are important for understanding patients' future cancer risk and for therapy selection.

Last week, for example, the US Food and Drug Administration approved Myriad's BRACAnalysis CDx, a germline test, for identifying early-stage breast cancer patients considering adjuvant treatment with AstraZeneca/Merck's Lynparza (olaparib), adding to the test's existing approvals for guiding PARP inhibitors for advanced breast, ovarian, pancreatic, and prostate cancers. Myriad's MyChoice CDx, meanwhile, assesses tumor tissue, and is approved for identifying ovarian cancer patients eligible for PARP inhibitors.

Beyond PARP inhibitors, the FDA's tissue-agnostic approval of Merck's Keytruda (pembrolizumab) based on tumor mutational burden and TRK inhibitors based on NTRK rearrangements, means that advanced breast and ovarian cancer patients should also be evaluated for these options. A large tumor profiling panel, like the one performed by Intermountain, can identify these on-label and other biomarker-informed off-label treatment opportunities for patients.

Bradley Monk, a gynecologic-oncologist at the Biltmore Cancer Center in Phoenix, treats patients with ovarian, uterine, cervical, vaginal, and vulvar cancers, and has been ordering germline testing and BRCA1/2 and homologous recombination deficiency (HRD) companion diagnostics from Myriad, but has to turn to other labs like Foundation Medicine, Tempus, and Caris Life Sciences for broader tumor profiling panels.

For a while, he's been asking Myriad to offer a bigger somatic testing panel, and he said he has also requested that Foundation offer germline testing, so he can get all his testing needs met by one lab. "I don't care who does it," said Monk, who doesn't have a financial relationship with Myriad and did not test out the Precise service during the soft launch. "But it has to be a very reputable company. Foundation is reputable and so is Myriad, and Myriad decided to … really create an opportunity for me and my patients."

Supporting doctors

Services like this, when coupled with education and the appropriate support, can also improve access disparities in precision oncology, experts said. In McLeod's view, all ovarian and endometrial cancer patients should have germline testing on a large NGS panel to assess their heritable cancer risk, but only 20 percent to 30 percent of patients who should have germline testing are getting it. On the somatic side, McLeod also encounters ovarian and endometrial cancer patients who haven't had their tumors sequenced or who have been tested, but their doctors don't know which of the findings to act on.

"You may think, who doesn't know about immunotherapy? Well, there are still areas of oncology where doctors don't realize that a high tumor mutational burden equals access to immunotherapy," said McLeod.

While NGS testing offers patients the best opportunity for personalized care, the reports are long and contain complex genomic information that's difficult for the busy community oncologist to quickly interpret. McLeod is a proponent of supporting community practitioners with what he calls "the last mile challenge" in precision oncology, and has cofounded a service, called Clarified Precision Medicine, with Lincoln Nadauld, chief of precision health and genomics at Intermountain, that provides on-demand molecular tumor board expertise to oncologists who need help making treatment decisions for patients based on NGS reports.

Recognizing that through Precise oncologists will be able to order not one NGS test but three — MyRisk, MyChoice CDx, and Precise Tumor Molecular Profile — Myriad will provide summary findings through the portal that pull out the salient clinically actionable findings for oncologists. The company has a suite of online tools doctors can implement in their offices that can, among other things, help determine which patients meet practice guidelines for the tests being offered. The company's regional sales teams and medical specialists, also serve in the "frontlines … to make sure that clinicians are practicing at the highest level," in line with the latest recommendations and guidelines, Slavin added.

Myriad also recognizes the importance of oncologists' having access to independent peer-to-peer support. "In rolling out Precise, we will be working towards a molecular tumor board that will be launching soon," Slavin said.

Such a program may help with reimbursement, which can be a major barrier in precision oncology. While Medicare coverage has improved for NGS cancer panels in recent years, commercial insurers can be resistant to paying for large NGS panels and the experimental treatments that test results can point to. This creates headaches for doctors who must justify to payors that their testing and treatment decisions are medically necessary for patients.

Community oncologists that have access to a molecular tumor board increasingly attest to the fact that a letter from experts laying out the evidence base and rationale for treatment decisions based on NGS test findings increases the chances that insurers will cover the therapy, particularly when testing points to off-label drugs.

Myriad declined to disclose the list price for the combined test offering, but Slavin highlighted that the company has contracts with more than 95 percent of payors for its tests and tries to lower out-of-pocket costs for patients through financial assistance programs. Additionally, according to the firm, 90 percent of the patients it tests end up paying $100 or less. With regard to its newest offering, the tumor profiling panel, Myriad said that this type of testing is generally considered reimbursable when performed on advanced, metastatic, relapsed, or refractory cancer patients.

Advancing research, data sharing

On the research front, Myriad will collect the genomic and clinical data on patients tested through this new testing service and make it available to researchers in a de-identified fashion through the Precise Treatment Registry. Myriad set up a steering committee of leading oncologists who helped define best practices and identify the data types to include in the registry.

The registry, powered by DNAnexus' bioinformatics platform, will allow researchers to analyze patients' genomic and clinical information, such as ancestry, geography, and cancer diagnosis. Slavin said over time, the registry will include information about patients' treatment outcomes, too. Researchers will "be able to combine that [clinical data] with the genomic information [and] do a lot of genetic epidemiology research" he said, highlighting that the registry will allow researchers to easily analyze germline, HRD, and tumor profiling data side by side.

Myriad has a large, proprietary database that houses the variant data from all the patients it tests. The Precise Treatment Registry "won't have all of Myriad's data, but it will be a good amount, which we will build very rapidly over time," Slavin clarified. Researchers will have to request access to the registry, he noted, and there will be a vetting process for projects where investigators wish to download the data and perform in-depth analysis.

In the past, Myriad has faced the ire of genomics researchers due to its historical enforcement of BRCA1/2 gene patents and for maintaining its variant database as a trade secret, though the company has always defended that it does share data through publications and research collaborations.

Slavin highlighted, for example, that Myriad is conducting research using genomic results from its database and the National Cancer Institute's Surveillance, Epidemiology, and End Results Program registries for California and Georgia. And before launching the Precise Treatment Registry, Myriad shared germline cancer testing data from its MyRisk panel via another registry, called PROMPT, using which researchers are trying to improve understanding of the penetrance of cancer risk variants and variants of unknown significance.

Some years ago, despite past criticism of the inaccuracies in public variant databases, the company's women's health division began submitting variants detected through prenatal testing to the public archival database ClinVar.

Slavin said Myriad is in talks about further involvement with ClinVar and its sister effort ClinGen, which convenes expert reviewers who curate and improve the accuracy of variant classifications in the database. "We do take it seriously," said Slavin, who was previously a clinical geneticist at City of Hope and served on ClinGen expert variant curation committees. "We're looking at a lot of different options."

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