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LabCorp Distribution Deal Allows OmniSeq to Focus on Studying Utility of Molecular Tests


NEW YORK (GenomeWeb) – Cancer molecular diagnostics firm OmniSeq's decision this week to exclusively distribute two of its tests through LabCorp will allow it to benefit from the large reference lab's sales force, its extensive customer base among oncologists and pathologists, and its outsized footprint in oncology research.

The Roswell Park Cancer Institute subsidiary markets OmniSeq Comprehensive, a 144-gene next-generation sequencing tumor profiling test that doctors can use to guide treatment decisions for cancer patients. In June, the firm began providing doctors at Roswell Park and other key opinion leaders early access to Immune Report Card, a service that creates a "comprehensive immune profile" based on five tests for cancer patients considering treatment with checkpoint inhibitors.

This week, OmniSeq announced that these two tests will be exclusively offered by LabCorp through Integrated Oncology, which provides a broad menu of tests to oncologists and pathologists in the US, and through its contract research organization Covance Drug Development, which has a large presence in conducting trials for oncology drugs. Additionally, LabCorp Chief Scientific Officer Marcia Eisenberg will join OmniSeq's board of directors and the reference lab will participate in OmniSeq's Series B funding round.

"We believe it is easier to sell new products to existing customers than to sell new products to new customers," said OmniSeq Chief Commercial Officer Matt Klusas, explaining why it will be easier for LabCorp to sell OmniSeq Comprehensive to doctors who are currently ordering single-analyte tests and Immune Report Card to doctors ordering PD-L1 immunohistochemistry testing for patients.

OmniSeq is working on studies to evaluate how Immune Report Card and OmniSeq Comprehensive impact patient outcomes. The distribution tie up with LabCorp will open up more opportunities to explore the utility of these tests in real-world settings and as part of drug development trials.

"The arrangement [with LabCorp] allows OmniSeq to concentrate our limited resources on continuing to iterate on these assays with a tight-knit group of key opinion leaders," Klusas said. "LabCorp can focus on serving their existing customers at scale with innovative assays, contracting for reimbursement, and operational efficiency."

With regard to Immune Report Card, Klusas said the company is eager to "start working with some of the leading clinical trial institutions around the US, to use it for the purposes of enriching for patient selection."

OmniSeq launched its 144-gene NGS panel more than a year ago. However, earlier this year a survey of oncologists revealed that they may be shifting away from targeted drugs using a precision testing approach in favor of recently approved checkpoint inhibitors. At Roswell Park, for example, use of immunotherapy drugs is growing more than 75 percent per year.

There are various reasons for the shift away from targeted drugs and toward immunotherapy, with the main attraction being that a subset of patients are seeing their tumors disappear and not recur following immunotherapy. Comparatively, patients receiving targeted drugs experience robust responses initially, but eventually the cancer recurs and becomes resistant to the therapy.

Despite the more attractive, curative potential with immunotherapy, however, the majority of patients receiving them won't have such enduring responses. Presently, PD-L1 expression tests are available to identify best responders to immunotherapy, but there is disagreement among oncologists about the utility of this biomarker to definitively separate responders from non-responders.

The uneven acceptance of PD-L1 in therapy selection is reflected in a survey OmniSeq conducted in May, in which it asked 100 oncologists to rank the most important marker in terms of immunotherapy selection. The survey showed that even though 32 percent of physicians indicated PD-L1 expression analysis via immunohistochemistry was most important, around 39 percent ranked it as the least important factor.

The survey also gauged how doctors felt about other biomarkers, such as mutational burden, microsatellite instability, and tumor-infiltrating lymphocytes. Oncologists know that "some of the standard biomarkers used today, like PD-L1 IHC and even mutational burden are not, in and of themselves … the best way to necessarily determine whether someone should receive these drugs," Klusas said.

The survey pointed to a need for better diagnostic tools to guide treatment decisions for immunotherapy, and OmniSeq launched Immune Report Card in response. Immune Report Card combines five tests in a single report: CD3/8 and PD-L1 analysis via immunohistochemistry; PD-L1/2 copy number changes using florescent in situ hybridization; microsatellite instability testing; mutational burden analysis via Thermo Fisher Scientific's Ion Torrent next-generation sequencing of more than 400 cancer genes; and gene expression analysis of 54 transcripts via targeted RNA-seq using the Oncomine Immune Response Research Assay.

According to the results of the survey, 57 percent of oncologists also indicated that they'd be more likely to enroll patients on immunotherapy trials over targeted treatment trials, while 34 percent said they'd be equally likely to enroll patients into trials for either type of treatment. Klusas noted that there are more than 800 clinical trials ongoing for immunotherapy.

"We have talked to some institutions who really have no means today … to consider how to rationally assign people to these trials," he said, and as a result, people are being assigned to trials based on the availability of open slots on studies, as opposed to using their molecular profile to direct enrollment.

OmniSeq wants Immune Report Card to be a tool that can drive more rational clinical trial enrollment in the immunotherapy setting. The service combines five kinds of molecular analysis into a single report and ranks the expression of immune markers for a patient relative to OmniSeq's growing reference population. OmniSeq has built a database of 167 reference patients who were treated at Roswell Park Cancer Institute, but Klusas noted that the company is in the process of adding data from several hundred more patients to this database.

Sometimes, the report may clearly point to a particular immune phenotype for a patient, other times the results may not be so clear. Klusas noted that there have already been a couple of cases where the patient has had conflicting results when PD-L1 expression was measured by IHC, by RNA-Seq, and then copy number changes were determined by FISH.

As such, it's important to keep in mind that "Immune Report Card isn't meant to provide a direct treatment recommendation," he said, and that ultimately the decision is up to the doctor as to how to treat the patient. In most cases, he noted that the report indicates a number of paths that a patient can take in terms of monotherapy, combination treatments, and clinical trials.

Because Immune Report Card has been available to doctors for a short time, it's not yet clear how they're using the information in the care of patients. But the LabCorp distribution deal would certainly allow OmniSeq to scale up access to Immune Report Card, and gather more insights on whether doctors are finding the information useful.

Additionally, OmniSeq is working on Immune Advance, a test that it hopes to market as a tool for predicting response to immunotherapy agents, as well as for identifying patients who might experience an adverse reaction to such drugs.