Laboratory Corporation of America entered the next-generation sequencing oncology market this week with the launch of a 50-gene cancer panel for tumor analysis, while Foundation Medicine expanded its testing menu by releasing a 405-gene panel for hematologic cancers last week.
LabCorp's IntelliGen assay covers approximately 2,600 mutations in 50 oncogenes or tumor suppressor genes and will be available through Integrated Oncology, one of the firm's specialized laboratories.
While the list of genes included in the panel was not immediately available, it contains genes known to be important for the development, progression, and treatment of cancer, including "well-established biomarkers that may direct therapeutic decisions," according to the company.
LabCorp said that cancer treatment has recently shifted to biologic drugs that target specific genomic alterations in tumors, requiring new tests. Those tests need to provide "more diagnostically significant information" and correctly identify mutations in small samples from tumors detected at an early stage, including mutations present in only a fraction of a sample. "LabCorp's NGS platform meets both of these demands," the firm said.
The new test may be useful, LabCorp said, when a guideline-recommended biomarker evaluation yields no therapeutic option; when tumors progress and patients relapse after therapy; when a tumor is poorly differentiated and of uncertain origin; when there is no effective standard-of-care therapy at the time of diagnosis; when tissue for a biomarker evaluation according to guidelines is limited; or when it would be useful to profile potential gene targets broadly for future clinical trials.
LabCorp did not immediately respond to requests for additional information about the assay, but during the company's third-quarter earnings call in October, CEO and President David King provided some more details.
According to King, IntelliGen's main utility is for solid tumors, though it includes "some specific applications" in leukemia and lymphoma.
He declined to provide pricing information at the time, noting that the company was discussing prices with payors.
Over the next several quarters, he said, LabCorp will offer "more comprehensive oncology panels" that will include additional content for liquid tumors, gene rearrangements, and prognostic and predictive markers. Further, the firm will offer more targeted tests, including one for Lynch syndrome, an inherited condition that increases the risk for colorectal cancer.
King said that with its first oncology panel, the firm "has focused on not what's the broadest spectrum that we could test" but "the key genes that need to be looked at."
"This will be our initial launch," he said. "We will continue to add content and services."
IntelliGen is not LabCorp's first entry into next-gen sequencing-based diagnostics. In February, the company launched, GeneSeq Cardio, its first NGS-based assay, which assesses mutations in a number of genes associated with inherited cardiac diseases.
One of LabCorp's main competitors in the oncology next-gen sequencing arena will be Foundation Medicine, which entirely focuses on NGS-based somatic cancer testing.
Earlier this year the company launched FoundationOne, an NGS-based assay for solid tumors that includes about 240 cancer-associated genes and some introns, and published an analytical validation study of the test in October.
More than 2,500 of the assays were ordered by oncologists during the third quarter, and the test generated approximately $4.4 million from clinical customers during the quarter. Average reimbursement from third-party payors was about $3,300 per test, so about 1,300 tests contributed to clinical revenue in the quarter.
Last week the company, which went public in September, launched its second NGS-based test, FoundationOne Heme, for hematologic cancers and certain sarcomas and pediatric cancers.
The company developed the test in collaboration with researchers at Memorial Sloan-Kettering Cancer Center over the past seven months. FoundationOne Heme combines targeted DNA sequencing with RNA-seq.
It sequences 405 cancer-related genes and covers all classes of genomic alterations, including single-base substitutions, insertions and deletions, copy number alterations, and select gene rearrangements.
In addition, the test applies RNA-seq to 265 genes in order to assess gene fusions in those genes, which are common driver mutations in hematologic cancers, sarcomas, and pediatric cancers.
Researchers at MSKCC validated the accuracy and performance of the test on more than 400 patient samples, Foundation Medicine said, and the company and its collaborators are presenting data on the test from 10 studies at the American Society of Hematology Annual Meeting this week.
Both LabCorp and Foundation Medicine's NGS tests are competing with cancer panels developed in-house by various cancer centers and other clinical laboratories, aided by kits from vendors of next-gen sequencing platforms for the targeted amplification of cancer genes.
Illumina's TruSeq Amplicon Cancer Panel, for example, targets 212 amplicons, hotspot areas in 48 cancer genes, and is optimized for its MiSeq system, while Life Technologies' Ion AmpliSeq Cancer Hotspot Panel v2 for the PGM includes about 200 amplicons from 50 cancer genes, and its Comprehensive Cancer Panel covers 409 complete genes. Qiagen also currently offers a number of cancer gene panels, which it plans to sell with its GeneReader sequencing platform next year.
However, LabCorp's King said he believes NGS-based tumor testing will be largely performed by centralized testing laboratories going forward, rather than individual labs.
"These are complex and sophisticated tests," he said during the firm's earnings call. "They require a high degree of specialization, and so I think the centralized scale reference laboratory is going to be the obvious place to perform them."