NeoGenomics Announces the Launch of Biomarker Assist KRAS Single Gene Testing (SGT) Program for Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer Patients

Rhea-AI Summary

NeoGenomics has launched an Amgen-sponsored program to provide KRAS G12C testing for advanced or metastatic non-small cell lung cancer (NSCLC) patients at no cost. This initiative aims to enhance personalized medicine by identifying viable treatment strategies for eligible patients. The program, part of Amgen's Biomarker Assist^TM, will help address barriers in education and access, ensuring more patients receive the necessary testing. NSCLC comprises 85% of lung cancer cases, with KRAS G12C being a prevalent biomarker.

Positive

• Launch of no-cost KRAS G12C testing for NSCLC patients, potentially increasing patient access to personalized treatments.
• Partnership with Amgen enhances NeoGenomics' capabilities in biomarker testing, improving company visibility and credibility in oncology.

Negative

• None.

SGT Program will provide KRAS G12C testing to eligible patients at no cost, regardless of insurance type.

FT. MYERS, FL / ACCESSWIRE / April 19, 2021 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, is excited to launch an Amgen-sponsored testing program to support single-gene molecular testing for the biomarker KRAS G12C for eligible lung cancer patients at no cost to the patient.

As part of Amgen's Biomarker Assist^TM KRAS Single Gene Testing Program, Amgen will sponsor testing for the KRAS G12C biomarker for patients suffering from advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC) through NeoGenomics. The sponsored testing program will leverage NeoGenomics' experience in biomarker testing, with Amgen funding the total cost of the tests performed by NeoGenomics, regardless of patient's insurance coverage or test results.

In the U.S., NSCLC accounts for approximately 85% of all lung cancer cases. KRAS G12C is the most prevalent emerging biomarker found in NSCLC, (1 in 8 patients [13%] with non-squamous NSCLC has the KRAS G12C driver mutation)^1,2. Major clinical practice guidelines for NSCLC (CAP/IASLC/AMP and ASCO) recommend testing for both actionable and emerging biomarkers utilizing either a comprehensive panel or targeted testing^3,4,5. Real-world biomarker testing data shows significant gaps in testing rates compared to guideline recommended practices^5,6.

"Biomarkers such as KRAS G12C increasingly serve as a critical tool to identify the personalized treatment strategy for cancer patients," said Mark Mallon, NeoGenomics' Chief Executive Officer. "We look forward to leveraging our broad capabilities and reach in U.S. clinical oncology along with Amgen to help accelerate awareness and the importance of biomarker testing to further current and developmental therapeutics and support the cancer community we serve."

"Biomarker testing is an integral component of personalized medicine especially for patients with non-small cell lung cancer. Instead of a one size fits all approach to treating every patient, medical advances over the last decade have led to a greater understanding of biomarkers and the development of innovative targeted therapies that have improved patient outcomes," said Darryl Sleep, Senior Vice President, Global Medical, and Chief Medical Officer at Amgen. "Unfortunately, many patients still do not receive biomarker testing due to barriers in education, access and reimbursement. Amgen's Biomarker Assist^TM program is designed to help more patients with advanced non-small cell lung cancer gain access to testing. NeoGenomics' KRAS Single Gene Test is an important component of this program."

All patients with advanced or metastatic (stage IV) non-small cell lung cancer may be eligible to participate in the Biomarker Assist^TM KRAS Single Gene Testing Program. For more information, including full terms and conditions of the program, please visit: www.BiomarkerAssist.com or www.NeoGenomics.com/KRAS-G12C.

1. Data on file, Amgen; [Analysis of AACR Genie v8].

2. Duma N, et al. Mayo Clin Proc. 2019;94:1623-1640.

3. Kalemkerian GP, et al. J Clin Oncol. 2018;36(9):911-919.

4. Lindeman NI, et al. Arch Pathol Lab Med. 2018;142:321-346.

5. Pennell NA, et al. Am Soc Clin Oncol Educ Book. 2019;39:531-542.

6. Gierman HJ, et al. J Clin Oncol. 2019;37(15_suppl):1585.

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, Carlsbad and San Diego, California; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in 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.

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 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, 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, 2021. 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 https://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.

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

Charlie Eidson
Manager of Investor Relations and Manager of Strategy and Corporate Development
T: 239.768.0600 x2726
M: 952.221.8816
charlie.eidson@neogenomics.com

SOURCE: NeoGenomics, Inc.

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FAQ

What is the KRAS G12C testing program by NeoGenomics?

NeoGenomics has launched an Amgen-sponsored program that provides KRAS G12C testing for eligible advanced or metastatic non-small cell lung cancer (NSCLC) patients at no cost.

Who is eligible for the KRAS G12C testing program?

Patients with advanced or metastatic (stage IV) non-small cell lung cancer may be eligible for the KRAS G12C testing program.

What is the significance of the KRAS G12C biomarker in lung cancer?

KRAS G12C is the most prevalent emerging biomarker in NSCLC, found in approximately 13% of non-squamous NSCLC patients, playing a critical role in personalized treatment strategies.

How does the Biomarker Assist program improve access to testing?

The Biomarker Assist program, sponsored by Amgen, aims to reduce barriers related to education, access, and reimbursement for patients needing biomarker testing in lung cancer.

What type of cancer does the KRAS G12C testing target?

The KRAS G12C testing specifically targets non-small cell lung cancer (NSCLC), which accounts for around 85% of all lung cancer cases.