NEW YORK (GenomeWeb) – Pathology services provider PathGroup last month launched a number of cancer-specific gene panels for newly diagnosed patients to complement its existing, more comprehensive panels for patients with advanced or treatment-refractory tumors.
The new panels, for lung, colon, brain, and thyroid cancer as well as melanoma and gastrointestinal stromal tumors, enable PathGroup to offer "a full range of molecular oncology tumor profiling products" that cover both patients at initial diagnosis and at later disease stages, according to Pranil Chandra, PathGroup's medical director of molecular pathology services.
Privately owned PathGroup, based in Brentwood, Tennessee, just south of Nashville, employs more than 75 pathologists and offers a range of pathology services, including anatomic, clinical, and molecular testing. While most of the company's business comes from a 550-mile radius around Nashville, it has started accepting samples from other states, including California, Florida, Illinois, and Virginia, and is considering to offer its services outside the US .
Over the last few years, the company has been investing in new molecular pathology services, which include women's health, infectious disease, and molecular oncology.
Chandra noted that molecular oncology, in particular, "is the quickest area of growth for us in terms of testing volumes and the tests we deploy." The firm markets its tests, which are performed in its CLIA-certified and CAP-accredited clinical laboratory, to oncologists and pathologists and has designed educational material to inform them about their value.
In 2013, PathGroup launched two so-called SmartGenomics tests for patients with advanced, aggressive, or relapsed tumors that combine targeted next-gen sequencing with cytogenomic microarray analysis. The NGS panels, which cover 62 genes for solid tumors and 85 genes for hematologic malignancies, analyze small variants whereas the arrays look for structural alterations, such as deletions and amplifications. The company also teamed up with GenoSpace and Thomson Reuters for analyzing and interpreting the results.
"In more than 90 percent of cases, you will find an aberration that will either result in increased prognostic information or that may influence a therapeutic decision, specifically with regard to targeted therapies available in a clinical trial," Chandra said, adding that the company will present data on the use of NGS and arrays in combination at the Cancer Genomics Consortium and Cytogenomics Array Group summer meeting in Denver next month.
Combining the two platforms is not the only possible way to find all relevant actionable mutations, he said, but the approach has "worked really well for us." PathGroup has set up workflows to run the NGS panels and arrays in parallel, allowing it to return results within seven to 10 business days on average.
But the company also saw a need for more targeted, cancer-specific panels, he said, both to keep costs down and because of reimbursement and regulation challenges. As a result, based on guidelines from the National Comprehensive Cancer Network and "high-impact" publications, the lab designed the new targeted panels, which became operational at the end of last year and were officially launched last month.
The panels differ in size, from a handful to a couple of dozen genes, and can be modified quickly as needed. PathGroup plans to design additional panels based on customer demand and new publications. Most likely, the next panel will focus on breast cancer or gynecological cancers, Chandra said, and the firm is considering panels for myeloid leukemia and possibly lymphoma.
Both the targeted and the more comprehensive panels currently run on the Illumina MiSeq, but to scale up operations, PathGroup plans to switch all of its cancer NGS testing to the Illumina NextSeq 500 this month.
Reimbursement for molecular oncology tests is currently "not commensurate with the value that they bring to the healthcare system," Chandra said, adding that he and his team spend a lot of time educating payors and other stakeholders.
Generally speaking, prices for genomic tumor profiling tests range from about $1,000 to more than $5,000, he said, but given that targeted therapies can cost hundreds of thousands of dollars per month, "these tests provide very high value."
"Being able to predict who is going to respond to therapy is equally important as being able to identify patients who are not going to respond to therapy," he said, in order to reduce overall healthcare costs.
"The literature is there, and the evidence is there, and it continues to emerge," Chandra said. Retrospective clinical trials have already demonstrated clinical utility for next-gen sequencing, "and now those findings are being corroborated as we speak by ongoing prospective studies. So it's a matter of time, but right now, it's a very challenging environment from a reimbursement perspective."