Partnership Seeks to Offer Combined Somatic, Germline Testing to Guide Cancer Treatment

A new partnership between leading precision medicine companies seeks to give patients with cancer—and their physicians—the most complete look possible at their disease by evaluating both the molecular and genetic elements.

Caris Life Sciences, a leader in somatic testing on cancer tumor cells, has joined forces with Ambry Genetics to offer its 67-gene test that evaluates a patient’s hereditary risk for cancer.

The partnership with Ambry “is about being as comprehensive as possible for patients and physicians, to optimize treatment selection by more broadly identifying the hereditary components that would indicate that a family is at higher risk for cancer,” said David Spetzler, PhD, MBA, president and chief scientific officer at Caris, in an interview with The American Journal of Managed Care^®.

Testing patients can receive through this collaboration includes both Caris Molecular Intelligence, which evaluates DNA, RNA, and proteins in a tumor, as well as Ambry’s CancerNext-Expanded hereditary cancer panel, which can tell if a patient is at increased risk of brain, breast, colon, ovarian, pancreatic, prostate, renal, uterine, and other cancers.

The role of both somatic and germline testing has become more important in guiding treatment. The 2019 annual conference of the National Comprehensive Cancer Network (NCCN) featured guideline updates calling for more comprehensive testing in multiple cancers, including a recommendation that all patients with ovarian cancer have germline testing to determine if poly ADP ribose polymerase (PARP) inhibitors should be used. In prostate cancer, NCCN calls for tumor testing as well as germline testing in cases where family history indicates mutations. A new guideline issued for January 2020 includes major updates for testing in breast, ovarian, and pancreatic cancer.

“Testing for germline BRCA is on guideline and is an indication for administration of a PARP inhibitor in breast cancer,” Spetzler said. Thus, a collaboration that makes it easier for patients and physicians to access both tumor and hereditary cancer tests will lead to more optimal treatment, he said.

In addition, Spetzler said, the partnership could lead to more efficient use of tissue collected during the diagnostic workup.

Improving access to testing is important, he said, because too often tests that are called for in NCCN guidelines are not done, despite the availability of the technology. He pointed to non—small cell lung cancer as an example where better utilization of testing could help guide decision making; the NCCN guidelines discuss at length the importance of identifying epidermal growth factor receptor (EGFR) mutations to guide treatment, but Spetzler said, “We still aren’t testing for EGFR more broadly.”

Spetzler’s concerns were borne out in research presented last May at the American Society of Clinical Oncology meeting; authors found that genomic testing in NSCLC was underutilized in community oncology practice. The study of 1200 patients in the Integra Connect database with NSCLC found that testing rates for EGFR were just 54%; testing for EGFR plus ALK, ROS1, and BRAF were only 22%.

Barriers to testing, he said, are much less likely to occur at the payer level than they once were. The challenge today is educating oncologists about the value of testing. Too many, Spetzler said, “are not familiar with this information or how to use it.”

Precision Oncology Alliance

To gain knowledge about the use of testing, Caris organized the Precision Oncology Alliance, which is a network of leading academic and large community oncology centers that are developing their own guidelines. Group members have published research at major conferences, and many members sit on NCCN committees that develop clinical guidelines.

Spetzler explained that these collaborations allow participants to pool patient data to produce results that no individual clinic would be able to see on its own. “It’s a beautiful network for trials for pharmaceutical companies,” he said, and it allows for standardization of testing across institutions.

Quality Counts

The reimbursement landscape for testing is much improved compared with 10 years ago, Spetzler said. “Most patients are going to be covered by insurance,” he said. Payers have developed criteria to evaluate the quality of different tests and laboratories, Spetzler said, and Caris has been able to demonstrate its value. Payer coverage, “is not really a limitation to access anymore in the way that it used to be. At least not for us.”