If you’re not in the field of oncology, you might be getting sick of all the cancer buzz dominating healthcare news feeds over the last few weeks.
There was the historic FDA approval of Merck’s Keytruda, an immunotherapy, for a genetic biomarker rather than a tissue of origin. It is now indicated for a range of solid tumors (breast, colon, pancreatic etc.), as long as the mutated cells carry so-called mismatched repair genes.
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Ten days later, oncologists from around the world descended on Chicago, Illinois, for the American Society of Clinical Oncologists (ASCO) annual meeting to discuss endless clinical trials for checkpoint inhibitors, CAR-T immunotherapies, companion diagnostics, liquid biopsies, PARP inhibitors, and TRK mutations.
It’s all precision medicine. And right now, the conversation is fixated on its application in cancer care.
On the other hand, precision oncology is a proof of principle for the wider medical field. It’s just a matter of time before such tests and treatments become mainstream in other specialties, from rheumatology to endocrinology to psychiatric care.
That future is met with a lot of enthusiasm by Johnathan Lancaster, chief medical officer of Myriad Genetic Laboratories. In a recent phone interview, Lancaster discussed the latest developments in oncology and their ability to usher in a new era of personalized medicine.
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“I really do believe we’re on the cusp of seeing precision medicine really transform not just how we view clinical practice day-to-day, but how clinical trials are designed and interpreted moving forward,” he said several days after the conclusion of ASCO.
We’re at a tipping point in oncology and it may well domino from there. When asked about the future of molecular diagnostics and precision medicine, the gynecologic oncologist was just as excited about its application in other disease areas.
“I mean there is a colossal, unmet clinical need in the neuro-psych space for primary care, OB/GYN, and psychiatrists who are managing patients with depression to tailor therapies,” Lancaster shared.
Myriad Genetics is well positioned to participate in that shift. Founded in 1991 in Salt Lake City, Utah, the molecular diagnostics company has long been a leader in genomics and precision medicine, first with hereditary cancer tests, then with companion diagnostics and tests that could inform prognosis and treatment decisions for diseases such as breast cancer.
In recent years, it has been branching out in alignment with what it calls its “four in six mission.” The idea is to help patients answer four major questions: Will I get a disease? Do I have a disease? Should I treat this disease? How should I treat this disease?
That philosophy is then applied to six disease areas; autoimmune, neuroscience, dermatology, oncology, preventive care, and urology. Oncology, while undoubtedly the most advanced, is just one piece of the precision medicine puzzle that is waiting to be filled in.
In 2014, Myriad acquired Crescendo Bioscience, a molecular diagnostics company focused on inflammatory and autoimmune diseases. It now markets the Vectra DA test for rheumatoid arthritis, which uses multiple biomarkers to better predict how a patient’s disease will progress over time.
Two years later, Myriad acquired Assurex Health, which specializes in genetic testing for guidance on behavioral health. Included in the deal was GeneSight, a pharmacogenomic test for major depressive disorder (MDD). At the time, Mark Capone, president and CEO of Myriad said the acquisition “provides a commercial channel into the neuroscience market, which we believe will be one of the highest growth areas for personalized medicine.”
Lancaster said the Genesight genetic test has been validated and has even shown “very impressive ” pharmacoeconomic modeling, in regards to the cost savings it can bring about for healthcare systems. After all, it’s not just a matter of getting patients and physicians on board. Payers also need to be convinced of the utility.
As it stands, a high percentage of patients taking therapies for MDD don’t stick with the treatment, Lancaster explained. A lot of the problem is the variable responses. If the patient metabolizes the drug too quickly, they won’t have enough active drug in their system, so they won’t think it’s working, he said. Conversely, they may be slow metabolizers, which can result in an excess of side effects and toxicities.
“Really for me, as a clinician, I feel like it’s a game changer for docs in the clinic who are managing patients,” Lancaster said of the test. “Instead of just throwing mud at the wall and hoping something sticks, we can now perform this genetic test and provide an individual patient with a list of drugs in the neuropsychology space.”
Other companies, such as Mayo Clinic spin-out OneOme are pursuing these kinds of pharmacogenomic tests. It’s far from routine in the clinic, but perhaps with the leaps being made in oncology, this kind of precision approach will be expected in other fields.
“It’s just an incredibly exciting time to be involved in precision medicine, whether it’s in the oncology arena or outside,” Lancaster said.
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