NEW YORK (GenomeWeb) – Seeking to tap into a growing market for more targeted oncology testing, N-of-One has added a new service to its clinical interpretation portfolio called PrecisionInsights, through which the company offers its interpretation capabilities to developers and customers of small gene panels comprised of 15 to 20 genes.
According to the company, customers of the new service will receive two-page reports that include the most recent clinical and scientific evidence relevant to the identified genes and variants as well as therapies and clinical trials relevant to the patient in question.
Chris Cournoyer, N-of-One's CEO, told GenomeWeb that the company will charge $65 per report as well as a one-time $1,000 implementation fee that covers the cost of putting in place the necessary infrastructure for electronically transferring files between N-of-One and its client. PrecisionInsights customers will upload results from tests of both solid and blood-based tumors in a standard file format along with de-identified patient information to the company's servers. N-of-One will then perform the interpretation and return the pdf report within a business day.
N-of-One is launching PrecisionInsights in response to a shift in the oncology market towards smaller, more targeted panels, Cournoyer said, highlighting Illumina's plans to launch a 15-gene cancer panel as an example of this trend. It's a shift that's borne out of a lack of clarity on exact reimbursement levels for NGS testing, she said, which has caused many institutions to focus on more targeted, clinically actionable panels that have a higher probability for reimbursement.
Furthermore, she said, "We are seeing increased adoption of NGS sequencing at the community level, in groups that were not using NGS before. These groups are starting with the smaller NGS panels, covering the genes that they would have tested individually, with the added benefit of additional genes, but without the large volume of results associated with large panels that are not immediately applicable to guideline-sanctioned therapy."
Smaller gene panels are also being introduced into mainstream oncology care for early-stage cancers, according to Cournoyer.
However, even with smaller panel sizes, there are still thousands of variants associated with different cancers that can be identified by these tests, she said. "The challenge that the industry faces is, 'how do we understand the combination of genes and thousands of variants and hundreds of diseases ... at a cost-effective price,'" she added.
PrecisionInsights addresses that need for more cost-effective testing without corresponding compromises in the accuracy and quality of its interpretations. Also, with this addition, "we now have a complete portfolio of clinical interpretation and molecular clinical trial matching solutions that range from the smallest NGS panels to the whole exome and across the spectrum of solid tumor, hematological, and liquid biopsy tests," Cournoyer said.
Like the company's existing interpretation offering, PrecisionInsights leverages the company's internal knowledgebase of clinical and scientific data gleaned from thousands of patient cases — it currently contains data on over 19,000 variants, 750 genes, and over 400 cancer types and subtypes. Access to that broad pool of data enables the company to provide detailed interpretations in the context of specific cancer subtypes, which has implications for the therapeutic strategy selected. The new service also benefits from the company's in-house team of scientists and oncologists, who will review reports for accuracy and clinical actionability.
N-of-One expects its newest service will be patronized by many of the same kinds of customers it already serves in the commercial diagnostic and clinical market. Its client list includes the Fox Chase Cancer Center, Norris Cotton Cancer Center, Cedars-Sinai Cancer Center, and the Mayo Clinic. It also has agreements in place to provide interpretation services for commercial test providers such as Guardant Health, Affymetrix, CompanionDx, GenomiCare, and, most recently, Spectrum. Cournoyer said the company will announce additional customers for its services in the coming months.
N-of-One also has a version of its variant interpretation tool in Illumina's BaseSpace applications store. Last year, the company announced an agreement with Syapse that would allow the companies to combine their respective products into an integrated informatics solution for clinical data interpretation. It signed a similar integration agreement with Cartagenia this year, which allows the companies to offer combined services to pathology laboratories. Also, N-of-One has a co-marketing agreement with Appistry that allowed both companies to jointly market and sell N-of-One's interpretation services and content together with Appistry's next-generation sequencing analysis solutions and services.