NeoGenomics Announces That Inivata Liquid Biopsy Subsidiary and Collaborators Have Published Clinical Validation Data for RaDaR(TM) Assay MRD Assay at AACR 2022

Data demonstrates potential of RaDaR to predict clinical response in stage III urothelial cancer

FT. MYERS, FL / ACCESSWIRE / April 11, 2022 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announced that its liquid biopsy focused subsidiary Inivata Limited (“Inivata”) has unveiled new data at the American Association for Cancer Research (AACR) Annual Meeting further demonstrating the potential of its RaDaR assay for the detection of minimal residual disease (MRD) and recurrence. The data being presented is from the NABUCCO study, which was run in collaboration with the Netherlands Cancer Institute.

Inivata is presenting data from a retrospective analysis based on 24 patients from the NABUCCO phase Ib trial in which high-risk resectable urothelial cancer patients received preoperative neo-adjuvant (NeoAdj) treatment of two immune checkpoint inhibitors (ipilimumab and nivolumab). In the study, RaDaR was used to analyze circulating tumor DNA (ctDNA) to determine whether post-treatment ctDNA levels correlated with treatment response and outcome.

The study found that following the NeoAdj treatment and prior to surgery, ctDNA was detected in only 7% of patients with pathological complete response to treatment compared to 60% of non-responders (p=0.0088). Of the 17 patients with undetected ctDNA following NeoAdj treatment and before surgery, 13 (76%) had pathological complete response and, importantly, 16 (94%) remained recurrence-free after a median follow-up of 34 months. These results suggest that plasma ctDNA changes after neoadjuvant treatment are associated with pathological response and have the potential to predict clinical outcomes.

David Eberhard MD PhD, Chief Medical Officer of Inivata said: “These latest data further demonstrate the potential for RaDaR to be informative in a variety of clinical settings across different tumor types. Along with continuing to generate clinical validation data, we will proceed with the regulatory pathway as we move towards commercialization of the assay.”

Michiel van der Heijden MD PhD, Medical Oncologist at the Netherlands Cancer Institute and Principal Investigator of the NABUCCO study, commented: “The results of this study highlight the potential of Inivata’s RaDaR ctDNA assay to predict clinical response to neoadjuvant treatment using a plasma sample before surgery takes place. This could ultimately help to guide clinical decisions in urothelial cancer, which is especially relevant in the context of selecting patients for the bladder-sparing strategies that are currently in development.”

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 seeks to adhere 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 help 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, Carlsbad and San Diego, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and Phoenix, Arizona; and CAP accredited laboratories in Cambridge, United Kingdom; 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. We routinely post information that may be important to our investors on our website at www.neogenomics.com.

About Inivata

Inivata is the liquid biopsy focused subsidiary of the NeoGenomics, Inc (NASDAQ: NEO) Group. Inivata’s InVision® liquid biopsy 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. The personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence and has been granted Breakthrough Device Designation by the US FDA. The commercially available InVisionFirst®-Lung test offers best-in-class sensitivity and turnaround and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs across a range of cancer types. Inivata has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.

About RaDaR^TM

RaDaR is Inivata’s assay for the detection of molecular residual disease (MRD) and recurrence. Built on Inivata’s proven InVision® liquid biopsy platform technology, RaDaR is a highly sensitive personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy, allowing both detection of residual disease following curative intent or definitive treatment, and early detection of relapse. RaDaR has been granted Breakthrough Device Designation by the US FDA.

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 generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “plan,” “potential” and other words of similar meaning. 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 commercialize RaDaR successfully and obtain appropriate reimbursement thereof, 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 25, 2022, as such information has been updated in subsequent SEC filings. As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. NeoGenomics routinely posts information that may be important to investors in the “Investor Relations” section of its website atwww.neogenomics.com. The Company encourages investors and potential investors to consult the NeoGenomics website regularly for important information about NeoGenomics.

Forward-looking statements speak only as of the date such statements are made (unless another date is indicated) and should not be relied upon 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.

For further information, please contact:

NeoGenomics, Inc.

Doug Brown
Chief Strategy and Corporate Development Officer
T: 239.768.0600 x2539
M: 704.236.2064
doug.brown@neogenomics.com

Charlie Eidson
Director, Investor Relations and Corporate Development
T: 239.768.0600 x2726
M: 952.221.8816
charlie.eidson@neogenomics.com

Karen Chandler-Smith
SVP Marketing and Communications
Inivata
+44 (0)7900 430235
karen.chandler-smith@inivata.com

Inivata Media Contacts:
Consilium Strategic Communications
Chris Gardner/Angela Gray/Genevieve Wilson
Alix Floyd (US)
inivata@consilium-comms.com
+44 (0)20 3709 5700

SOURCE: NeoGenomics, Inc.

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