OmniSeq Offers Differentiating Platform to Clinically Detect Rare Genetic Alterations to Identify Patients Eligible for New, Targeted Therapy for Lung and Thyroid Cancer

OmniSeq®, an innovator in next generation sequencing (NGS) in oncology, today announced the benefits of its OmniSeq Advance® comprehensive genomic and immune profiling assay to detect the presence of rare alterations in the RET gene in the tumors of some patients with non-small cell lung cancer (NSCLC) and thyroid cancer. Those patients eligible for treatment with Eli Lilly and Company's recently FDA-approved selective RET kinase inhibitor Retevmo™* (selpercatinib).

Retevmo is the first FDA-approved therapy specifically for cancer patients with fusions or mutations in the RET (rearranged during transfection) gene. OmniSeq Advance delivers the distinct advantage of using two technologies; RNA-sequencing for RET fusions and DNA-sequencing for RET mutations to provide optimal, comprehensive testing for Retevmo. OmniSeq Advance was one of the tests that could qualify a patient for enrollment to the LIBRETTO-001 Retevmo (selpercatinib) clinical trial.

The National Comprehensive Cancer Network® (NCCN) recommends for NSCLC that when feasible, testing be performed via a broad, panel-based approach, most typically performed by next generation sequencing. For patients who, in broad panel testing don't have identifiable driver oncogenes (especially in never smokers), consider RNA-based NGS if not already performed, to maximize detection of fusion events.

"OmniSeq Advance offers significant advantages for detecting RET fusions by RNA-sequencing as opposed to DNA-only sequencing," stated OmniSeq's Chief Medical Officer, Roger Klein, MD, JD, FACP. "OmniSeq's proprietary sample preparation methodologies also allow for minimal tumor tissue input, a critical factor for ensuring NSCLC patient testing can be completed with frequently limited biopsy material available."

OmniSeq's NGS-based assays provide comprehensive genomic and immune profiling from RNA and DNA to enable oncologists to select the most appropriate therapies or clinical trials for each patient. OmniSeq's suite of clinical diagnostic tests are offered exclusively by LabCorp to U.S.-based physicians through its Integrated Oncology specialty laboratory and to global biopharmaceutical customers through Covance, LabCorp's drug development business. OmniSeq Advance is approved by New York State's Clinical Laboratory Evaluation Program.

Retevmo is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer, of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trial(s). There is currently no FDA-approved companion diagnostic for Retevmo.