NeoGenomics Announces That Inivata Liquid Biopsy Subsidiary and Collaborators Have Published Clinical Validation Data for RaDaR(TM) Assay in Non-Small Cell Lung Cancer
Study further highlights potential of RaDaR to stratify patients and improve treatment outcomes
FT. MYERS, FL / ACCESSWIRE / March 17, 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 announced the publication of new data in support of its RaDaR™ liquid biopsy test in patients with early-stage non-small cell lung cancer (NSCLC). The data from the LUng cancer CIrculating tumor Dna (LUCID) study have been published in the Annals of Oncology. The study was in collaboration with Cancer Research UK Cambridge Institute, University of Cambridge, Royal Papworth Hospital and Cambridge University Hospital.
In the LUCID study Inivata’s RaDaR minimal residual disease (MRD) and recurrence assay was used to analyze the blood samples of 88 patients with early-stage (I-III) NSCLC who had been treated with curative intent. The study found that the presence of detectable ctDNA after treatment with curative intent was highly predictive of subsequent clinical recurrence. In patients who had detectable ctDNA at a ‘landmark timepoint’ after the end of cancer treatment, both the specificity and positive predictive value (PPV) were 100%, with ctDNA detection at this timepoint being strongly predictive of both clinical recurrence (Hazard ratio 14.8) and overall survival (Hazard ratio 5.8).
Importantly, the data showed that ctDNA detection preceded clinical detection of recurrence of the primary tumor by a median of 212.5 days, highlighting the potential of the assay to identify patients who may benefit from further early therapeutic intervention. It was also found that in 30% of those patients with detectable ctDNA, the variant allele frequency was less than 0.01% or 100 parts per million of ctDNA, underscoring the importance of highly sensitive assays for detecting residual disease and recurrence in lung cancer patients.
David Eberhard MD PhD, Chief Medical Officer of Inivata said: “The LUCID study provides further evidence in a clinical setting of the potential of RaDaR to detect residual disease across a range of tumor types. We look forward to conducting additional studies to provide further validation of our personalized, tumor-informed assay as we move closer to its commercialization.”
Professor Robert Rintoul FRCP PhD, Clinical Study Lead, University of Cambridge and Royal Papworth Hospital, Cambridge, commented: “There is a growing body of evidence for the utility of ctDNA testing in the detection of residual disease and recurrence. We believe there is potential for highly sensitive MRD assays such as RaDaR to transform the cancer treatment landscape by identifying patients at high risk of relapse who may benefit from additional therapy, whilst avoiding unnecessary treatment for low-risk patients.”
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 RaDaRTM
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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