NeoGenomics and ImmunoGen Launch New Program Giving Ovarian Cancer Patients Access to Novel FR Biomarker Testing to Support the Launch of ELAHERE(TM)

Program leverages NeoGenomics' expertise to provide ovarian cancer patients critical insights to ensure they are getting the right treatment

FT. MYERS, FL / ACCESSWIRE / November 18, 2022 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services, today launched a novel biomarker testing program for patients with epithelial ovarian cancer, including primary peritoneal or fallopian tube cancers (EOC).Through the FR-ASSIST™ program, sponsored by ImmunoGen, Inc., (Nasdaq:IMGN), EOC patients will have access to the FOLR1 IHC CDx test (VENTANA FOLR1 RxDx Assay) performed by NeoGenomics to measure the expression of a protein called folate receptor alpha (FRα).

The FR-ASSIST™ program was launched in conjunction with the recent U.S. Food and Drug Administration's approval of ELAHERE™ (mirvetuximab soravtansine-gynx), ImmunoGen's antibody-drug conjugate (ADC) targeting FRα in patients with platinum-resistant EOC.

The new testing program is sponsored entirely by ImmunoGen and provides eligible EOC patients with FRα-expression testing through NeoGenomics at no cost, regardless of insurance coverage or test results.

"We are excited to be partnering with ImmunoGen on this first-of-its-kind testing program. Together, we are combining our leadership in biomarker testing with ImmunoGen's expertise in developing novel targeted therapies to fill a critically-important unmet need in ovarian cancer," said Shashikant Kulkarni, MS (Medicine), PhD, Chief Scientific Officer, NeoGenomics.

FRα is rarely expressed in normal tissue, but is often elevated in solid cancer tumors, including EOC. Of the approximately 19,880 ovarian cancers diagnosed in 2022,[1] it would be expected that nearly 90 percent of these cases express FRα,[2]^,[3],[4]representing an attractive target for cancer treatment.

"Biomarker testing is an integral component of personalized medicine, especially for patients with ovarian cancer as it can support oncologists and their patients in making more informed decisions about treatment approaches," said Derek Lyle, M.D., Chief Medical Officer, NeoGenomics. "Sponsored programs like FR-ASSIST™ are an innovative and efficient way to ensure patients are getting the right test to help them receive the right treatment at the right time, particularly innovative targeted therapies that have been shown to improve patient outcomes."

"With the approval of ImmunoGen's ELAHERE™ - the first and only FRα-targeting ADC for platinum-resistant ovarian cancer - it is more important than ever that all EOC patients be tested for FRα expression," said Mark Enyedy, President and Chief Executive Officer, ImmunoGen. "Despite the vital information that biomarker testing provides, many cancer patients still do not undergo evaluation due to a lack of awareness, access, and reimbursement. By partnering with an innovation leader like NeoGenomics, our FR-ASSIST™ program is helping to break down these barriers so all EOC patients have access to FOLR1 IHC testing, regardless of insurance coverage."

All patients with EOC may be eligible to participate in the ImmunoGen's FR-ASSIST™ testing program. For more information, including full terms and conditions of the program, please visit: https://neogenomics.com/diagnostic-services/sponsored-testing-programs/folr1-ovarian-cancer-testing-program.

ELAHERE™ (mirvetuximab soravtansine-gynx) is a trademark of ImmunoGen, Inc. For more information, including important safety information, please visit https://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services, providing 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.

NeoGenomics is committed to connecting patients with life altering therapies and trials. We believe that, together, with our partners, we can help patients with cancer today and the next person diagnosed tomorrow. In carrying out these commitments, NeoGenomics adheres to all relevant data protection laws, provides transparency and choice to patients regarding the handling and use of their data through our Notice of Privacy Practices, and has invested in leading technologies to ensure the data we maintain is secured at all times.

Headquartered in Fort Myers, FL, NeoGenomics operates CAP accredited and CLIA certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo and San Diego, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Rolle, Switzerland; and Singapore and China. 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.

About ImmunoGen

ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Forward Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," expect," plan," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project, "guidance," "plan," "potential" and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, 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, and the risks identified under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 25, 2022 as well as other information previously filed with the SEC.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For further information, please contact:

NeoGenomics, Inc.
William B. Bonello
Chief Financial Officer
T: 239.768.0600 x2426
bill.bonello@neogenomics.com

[1] SEER cancer stat facts: ovarian cancer. National Cancer Institute. Accessed October 4, 2022.

[2] Markert S, Lassmann S, Gabriel B, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008;28(6A):3567-3572.

[3] Parker N, Turk MJ, Westrick E, et al. Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem. 2005;338(2):284-293.

[4]Toffoli G, Cernigoi C, Russo A, et al. Overexpression of folate binding protein in ovarian cancers. Int J Cancer. 1997;74(2):193-198.

SOURCE: NeoGenomics, Inc.