NeoGenomics Launches Immuno-Oncology Companion Diagnostic Test for Triple Negative Breast Cancer in Conjunction with FDA Approval for TECENTRIQ(R)

FT. MYERS, FL / ACCESSWIRE / March 11, 2019 / NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, today announced availability of the Ventana PD-L1 (SP142) Assay for tumor tissue from patients with the triple negative subtype of breast cancer. This PD-L1 assay is a companion diagnostic test recently approved by the FDA to identify advanced, metastatic triple negative breast carcinoma cancer patients who may respond to the immune checkpoint inhibitor therapy TECENTRIQ® (atezolizumab) used in combination with chemotherapy. TECENTRIQ is the first such immunotherapy approved specifically for breast cancer.

Triple negative breast cancer (TNBC) accounts for 10-20% of cases and is so named because tumors lack three biomarkers that are commonly targeted with drug therapies when present: estrogen receptor (ER), progesterone receptor (PR or PgR), and HER2. Absence of the three biomarkers makes TNBC difficult to treat because hormone therapies and HER2 inhibitors are not effective. TNBC can be aggressive with an increased risk of spreading and recurring compared to other breast cancer subtypes. The PD-L1 (SP142) Assay provides a new diagnostic test to determine if triple negative breast cancer patients are appropriate candidates for TECENTRIQ.

“Our launch of PD-L1 (SP142) will provide triple negative breast cancer patients with access to a critical companion diagnostic test for an important new treatment option,” said Douglas M. VanOort, NeoGenomics’ Chairman and CEO. “As a leading provider of oncology testing for clinical trials and patient care, NeoGenomics is in a unique position to bring companion diagnostic tests to market, and to do so with a sense of urgency. We are pleased to be offering this important new test immediately following FDA approval of TECENTRIQ.”

NeoGenomics is the leading provider of PD-L1 diagnostic testing, covering all approved indications. The laboratory’s experience was published in February in the article “Immunohistochemical detection of PD-L1 among diverse human neoplasms in a reference laboratory: observations based upon 62,896 cases” which appears in the journal Modern Pathology. PD-L1 is the cornerstone of NeoGenomics’ suite of immuno-oncology assays which include tumor mutation burden (TMB), mismatch repair (MMR) immunohistochemistry, and microsatellite instability (MSI) analysis.

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 and CLIA certified laboratories in Ft. Myers and Tampa, Florida; Aliso Viejo, Carlsbad and Fresno, California; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; 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 global pharmaceutical firms. For additional information about NeoGenomics, visit http://neogenomics.com/.

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, including the information set forth in the “Full-Year 2019 Financial Outlook”. 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, offer new types of tests, integrate its acquisition of the Genoptix business, 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 26, 2019. 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
Chief Strategy and Corporate Development Officer
Director, Investor Relations
(239) 690-4238 (w) (239) 284-4314 (m)
bill.bonello@neogenomics.com

SOURCE: NeoGenomics, Inc

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