NeoGenomics and QIAGEN Collaborate to Offer Companion Diagnostic Test for HR+/HER2 - Advanced Breast Cancer Patients to Detect a PIK3CA Mutation

FT. MYERS, FL / ACCESSWIRE / May 28, 2019 / NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, today announced availability of the QIAGEN therascreen® PIK3CA RGQ PCR test from QIAGEN N.V. (NYSE: QGEN, Frankfurt Stock Exchange: QIA) for post-menopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. This PIK3CA assay is a companion diagnostic test recently approved by the FDA to aid clinicians in identifying breast cancer patients suitable for treatment with Piqray®* (alpelisib), a newly approved therapy developed and marketed by Novartis. Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Approximately 70% of patients with breast cancer have the HR+/HER2- subtype, and approximately 40% of these patients have a PIK3CA mutation. In advanced breast cancer, PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment, and a poor overall prognosis.

NeoGenomics Laboratories will serve as the Novartis Day 1 Preferred Laboratory Partner for this critical companion diagnostic test.

"Our launch of the QIAGEN therascreen®** PIK3CA RGQ PCR test will provide 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 provide day-one access to companion diagnostic tests enabling patients to access important new therapies without delay. We are pleased to collaborate with Novartis to provide HR+/HER2- advanced or metastatic breast cancer patients access to a companion diagnostic test for its newly approved treatment, Piqray. In addition, the therascreen test is one of the first of what we expect to be many test launches based on our collaboration with QIAGEN to offer patients Day-One access to innovative companion diagnostics for newly approved drugs."

NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus. NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests.

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 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 pharmaceutical firms in Europe and Asia. For additional information about NeoGenomics, visit http://www.neogenomics.com/.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2018, QIAGEN employed approximately 5,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

* Piqray is a registered trademark of Novartis AG
** therascreen is a registered trademark of QIAGEN N.V.

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, amended by a 10K/A filed with the SEC on May 8, 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

William Bonello
Phone: +1 239 690 4238 / Mobile: +1 239 284 4314
bill.bonello@neogenomics.com

QIAGEN

SOURCE: NeoGenomics, Inc.

Released May 28, 2019