LabCorp agrees to exclusively distribute OmniSeq's Immune Report Card and OmniSeq Comprehensive clinical assays
LabCorp agrees to exclusively distribute OmniSeq's Immune Report Card and OmniSeq Comprehensive clinical assays

OmniSeq said today its Immune Report Card SM and OmniSeq ComprehensiveSM clinical assays will be distributed by LabCorp under an exclusive agreement whose value was not disclosed.

LabCorp will also participate in the upcoming series B financing of OmniSeq, a subsidiary of the Roswell Park Cancer Institute in Buffalo, NY, focused on cancer molecular diagnostics. OmniSeq said proceeds from the financing will go toward conducting ongoing retrospective and prospective clinical trials, as well as generating additional evidence of the clinical utility of its genomic and immune profiling services.

OmniSeq’s announcement did not disclose details of the financing. However, the company on Friday filed a Form D Notice of Exempt Offering of Securities with the U.S. Securities and Exchange Commission disclosing the sale of $10 million in debt toward a $20 million offering. Two investors have participated in the offering, the company said in the filing.

In addition, Marcia Eisenberg, Ph.D., CSO of LabCorp Diagnostics, has agreed to join OmniSeq’s board of directors.

OmniSeq said it will carry out the assays, which will be exclusively offered by LabCorp to U.S.-based physicians through Integrated Oncology, a member of the LabCorp Specialty Testing Group. Outside the U.S., the assays will be offered to biopharmaceutical customers through Covance Drug Development.

Immune Report Card, launched commercially in June, integrates five clinical-grade tests that together provide a “comprehensive immune profile” designed to help oncologists as they decide whether to treat their patients with checkpoint inhibitors such as Merck & Co.’s Keytruda® (pembrolizumab), Roche’s Tecentriq® (atezolizumab), and Bristol-Myers Squibb’s Opdivo® (nivolumab).

The five tests are CD3/8 and PD-L1 immunohistochemistry (IHC), PD-L1/2 copy number using florescent in situ hybridization (FISH), microsatellite instability testing (MSI), mutational burden (MuB) analysis via Thermo Fisher Scientific’s Ion Torrent® next generation sequencing (NGS) of 409 full exon cancer genes (DNA-seq), and cross-validated, simultaneous gene expression analysis of 54 critical transcripts via targeted RNA-seq using the Oncomine Immune Response Research Assay (OIRRA).

Among patients in OmniSeq’s reference population, according to the company, only 25% of patients were either PD-L1 high—a tumor proportion score over 50%—or had a high mutational burden. However, an additional 48% of patients highly expressed one or more targetable immune markers that are currently under evaluation in clinical trials.

“Immune Report Card may become an important tool to select immunotherapy combinations and to optimize likelihood of response to treatment,” Carl Morrison, president, founder and CSO of OmniSeq, said in a statement.

OmniSeq Comprehensive is a 144-gene, pan-cancer, next-generation sequencing tumor profiling diagnostic panel designed to guide decisions on oncology treatment. OmniSeq says Comprehensive’s sample requirements call for as little as 1/10 the standard tissue requirements of typical NGS panels—small enough to enable complete results from 98% of clinical samples received to date while providing actionable results for more than 80% of patients tested, which the company says is on par with other comprehensive genomic profiling assays.

Both Immune Report Card and OmniSeq Comprehensive have received approval from New York State’s Clinical Laboratory Evaluation Program.

“By combining OmniSeq’s technology with LabCorp’s unmatched companion diagnostics expertise, we will bring advances in precision medicine to many more physicians and biopharmaceutical partners,” Dr. Eisenberg added.

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