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Roswell Park Cancer Institute Spinout OmniSeq Offers Cancer Genomic Testing to Institutions

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NEW YORK (GenomeWeb) – A year after obtaining approval for its OmniSeq Target tumor profiling panel from the New York State Department of Health, Roswell Park Cancer Institute (RPCI) has spun out a company, also called OmniSeq, to make the test and related assays available to other institutions.

The company, located on the Buffalo Niagara Medical Campus in upstate New York, is majority-owned by RPCI but plans to accept additional investors in the future, according to its website. Carl Morrison, a professor at RPCI, is OmniSeq's president, chief scientific officer, and founder.

OmniSeq's goal is to make cancer genomic testing available to comprehensive cancer centers, oncology practices, and community oncology groups. Institutions gain access to its services by joining the OmniSeq Genomic Network on a trial basis, and as full members later on, allowing them to access all data from their patients and to initiate collaborations with each other.

OmniSeq, which has more than 30 employees, maintains its own clinical laboratory, which is CLIA-certified and approved under the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP).

According to Morrison, one feature that sets the company apart from other providers is its information technology system, called OmniSeq Connect. Doctors can order tests through an online portal that is also used to verify payment, coordinate sample collection, and deliver clinical reports. Turnaround time for the tests is five to 10 days from the date of the order.

Initially, the firm is offering the OmniSeq Target test, originally developed by RPCI's Center for Personalized Medicine, for non-small cell lung cancer, focusing on clinically actionable variants. In addition, it provides a number of single-analyte cancer diagnostic tests for a variety of solid tumors and leukemia types.

Starting with lung cancer was an easy choice as it is "the poster child of targeted therapies and precision medicine in cancer," Morrison told GenomeWeb. In the near future, the company plans to expand testing to melanoma and colorectal cancer and might add other cancer types, including breast cancer, later on.

In contrast to other vendors that offer large tumor panels of several hundred genes, OmniSeq decided to focus on small gene sets and to predefine actionable mutations for reporting, which increases the consistency of variant interpretation across patients, he said.

Targeting actionable mutations also increases the likelihood of reimbursement. The firm has already been "successful with payors in different marketplaces," according to Mark Aguillard, OmniSeq's vice president of marketing and managed care, and plans to make more information about this available in the near future.

The OmniSeq Target test for lung cancer reports on 60 actionable genomic variants with more than 120 predictive drug associations in 15 genes. Eight of these genes are included in guidelines from the National Comprehensive Cancer Network for predictive molecular diagnostic testing, while the other seven are currently being evaluated in clinical trials for response to experimental targeted agents.

While New York State requires all variants to be reported, the company distinguishes between clinically actionable and non-actionable variants in its report, "so that the physicians can understand what the most important information is," said Mary Nesline, OmniSeq's senior vice president of knowledge informatics.

The test analyzes primary or metastatic lung tumor samples, using three technologies: next-generation sequencing with Thermo Fisher Scientific's Ion Torrent PGM and Illumina's MiSeq platforms to detect single nucleotide variants and indels; fluorescent in situ hybridization to pick up fusions and translocations; and NanoString's nCounter molecular counting technology to find copy number variants.

The test is able to detect variants with allele frequencies below 5 percent. Using two different NGS platform allows the firm "to have an unparalleled sensitivity with essentially no false positives," Morrison said.

Clinicians receive a report that includes targeted therapies and clinical trials available for the patient. The report contains links at the gene variant level to resources about targeted treatment options.

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