NeoGenomics Launches Comprehensive Suite of Solid Tumor Liquid Biopsy Tests for Cancer Patients

FT. MYERS, FL / ACCESSWIRE / June 29, 2020 / NeoGenomics, Inc. (NASDAQ:NEO), 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."

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services. The Company provides one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development.

Headquartered in Fort Myers, FL, NeoGenomics operates CAP-accredited and CLIA certified laboratories in Ft. Myers and Tampa, Florida; Aliso Viejo, Carlsbad, Fresno and San Diego, California; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP-accredited laboratories in Rolle, Switzerland, and Singapore. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia. For additional information about NeoGenomics, visit http://www.neogenomics.com/.

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata's technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. Its lead product, InVisionFirst®-Lung is commercially available and offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR™ assay – allowing the highly sensitive detection of residual disease and recurrence. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs. The Company has a CLIA certified, CAP-accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow Inivata on Twitter @Inivata.

Forward-Looking Statements

Certain information contained in this press release constitutes forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward-looking statements as the result of the Company's ability to continue gaining new customers, respond to the effects of the COVID-19 outbreak, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, as well as additional factors discussed under the heading "Risk Factors" and elsewhere in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2020. As a result, this press release should be read in conjunction with the Company's periodic filings with the SEC. In addition, it is the Company's practice to make information about the Company available by posting copies of its Company Overview Presentation from time to time on the Investor Relations section of its website at http://ir.neogenomics.com/.

Forward-looking statements represent the Company's estimates only as of the date such statements are made (unless another date is indicated) and should not be relied upon as representing the Company's estimates as of any subsequent date. While the Company may elect to update forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if its estimates change.

For further information, please contact:

NeoGenomics, Inc.

William Bonello
Director, Investor Relations
(239) 690-4238 (w)
(239) 284-4314 (m)
bill.bonello@neogenomics.com

SOURCE: NeoGenomics, Inc.

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