NeoGenomics Launches Comprehensive Suite Of Solid Tumor Liquid Biopsy Tests For Cancer Patients

NeoGenomics, Inc., a leading provider of cancer-focused genetic testing services, announced today the launch of three liquid biopsy tests for advanced non-small cell lung cancer, all solid tumor types (pan-cancer), and certain breast cancer cases. With the addition of these new testing capabilities, physicians can now rely on NeoGenomics to deliver biomarker information from potentially any patient with a solid tumor or hematologic malignancy even when a tissue biopsy is not possible.

These new tests provide a peripheral blood option for detection of therapeutic targets and prognostic markers, and the three new assays have a turnaround time of seven days or less which can save clinicians valuable time over tissue testing in critical cases. Liquid biopsy is especially useful when tissue specimens are scarce or unattainable, as in lung cancer. Through the strategic collaboration with Inivata announced on May 26, 2020, NeoGenomics gained access to a highly competitive liquid biopsy assay, InVisionFirst-Lung, for testing patients with advanced non-small-cell lung cancer (NSCLC).

InVisionFirst-Lung is a ctDNA NGS liquid biopsy assay testing 37 genes relevant to the care of advanced NSCLC. The test covers all National Comprehensive Cancer Network (NCCN) guideline-recommended genomic drivers with FDA-approved targeted therapies for NSCLC. InVisionFirst-Lung results are delivered within seven calendar days from blood draw and the test is covered by Medicare and various private insurance payers for patients with advanced NSCLC meeting certain clinical criteria.

The new NeoLAB Solid Tumor Liquid Biopsy is especially well-suited for solid tumors beyond lung cancer, including breast, colorectal, melanoma, and other cancers. It is a highly sensitive and specific next-generation sequencing test for genomic profiling. NeoLAB Solid Tumor Liquid Biopsy joins our well-established suite of 14 NeoLAB tests for patients with hematologic diseases which provide opportunities for biomarker evaluation when bone marrow biopsy is not feasible and peripheral blood counts are low.

The QIAGEN therascreen PIK3CA RGQ PCR Kit is an FDA-approved companion diagnostic (CDx) test for PIQRAY (alpelisib). It detects 11 clinically actionable mutations in the PIK3CA gene using genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) isolated from K2EDTA anticoagulated peripheral whole blood plasma taken from patients with breast cancer. NeoGenomics validated the QIAGEN therascreen CDx for tissue testing shortly after PIQRAY (alpelisib) received FDA approval on May 24th, 2019 and in the coming weeks will launch the QIAGEN therascreen CDx for plasma testing to help address situations where PIK3CA testing cannot be performed using tumor tissue because of insufficient sample, low quantity of tumor cells or tissue sample decalcification.

"Liquid biopsy testing is an increasingly important tool. Being able to return results for solid tumor patients now means oncologists and pathologists can work with a single laboratory for comprehensive diagnostic and management testing," said Doug VanOort, CEO of NeoGenomics. "The launch of these three liquid biopsy assays exemplifies our commitment to providing the most comprehensive oncology menu for our clients as a one-stop-shop for their testing needs."