News | May 5, 2020

Bayer And NeoGenomics Launch The Test4TRK Program To Provide Genomic Cancer Testing At No Cost For People Living With Advanced Thyroid And Colorectal Cancers

WHIPPANY, N.J.--(BUSINESS WIRE)--

Bayer today announced the launch of Test4TRK™ program in collaboration with NeoGenomics, Inc. to offer genomic cancer testingfor NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management.1-3 Bayer will cover the full cost of the test regardless of the results, treatment decision and patient’s insurance coverage. All eligible patients who enroll and opt-in to the program will receive an RNA-based next-generation sequencing (NGS) test, NTRK NGS Fusion Profile. Patients with an adequate tissue sample will also receive a Pan-Tropomyosin receptor kinase (Pan-TRK) Immunohistochemistry (IHC) test.

Healthcare professionals and patients can visit www.Test4TRK.com to learn more and download the test request form or call Bayer Medical Communications at +1-888-84BAYER (+1-888-842-2937) for questions on NTRK gene fusions and TRK fusion cancer.

“The results of a genomic cancer test may be a deciding factor in treatment selection, especially for patients with differentiated thyroid cancer who have limited options,” said Marcia S. Brose, M.D., Ph.D., Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania and an Associate Professor in Otorhinolaryngology: Head and Neck Surgery at Penn’s Perelman School of Medicine, who collaborated on the development of the testing platform. “If we implement comprehensive genomic testing early upon diagnosis to uncover NTRK gene fusions, we may have a deeper understanding of patients’ tumors in aiding treatment decisions.”

Genomic cancer testing helps detect changes in a tumor’s DNA, called genomic alterations, that can determine how the cancer behaves and why it grows or spreads.4 30-49 percent of patients who undergo genomic cancer testing may have actionable genomic alterations, meaning the alterations can be matched to treatments that have been approved or are in clinical trials.5,6

“After receiving a cancer diagnosis, patients and their loved ones critically need information that can help guide the course of their treatment journey,” said Anjee Davis, president of Fight Colorectal Cancer (Fight CRC). "The Test4TRK program aligns with our commitment to empowering patients with educational resources. Colorectal cancer patients need to be armed with biomarker testing because their biomarkers can have an impact on treatment decisions, especially MSI-H. This can inform treatment plans and reduce financial barriers that could prevent some patients from receiving personalized care.”

Bayer has developed this program in collaboration with patient organizations Thyroid Cancer Survivors’ Association, Inc. (ThyCa) and Fight CRC as well as Marcia S. Brose, MD, PhD of the University of Pennsylvania. Dr. Brose serves in an advisory role for Bayer and receives honoraria and funding for research support.

The Test4TRK program provides testing for an NTRK gene fusion, which occurs when an NTRK gene joins together, or fuses, with a different, unrelated gene. The NTRK gene fusion creates certain proteins (TRK fusion proteins) that can cause cancer cells to multiply and form a tumor.1Cancers with NTRK gene fusionscan occur in tumors that originate in different sites in the body in varying frequenciesand are called TRK fusion cancers.7

“It is critical cancer patients have access to genomic testing for NTRK gene fusions to inform treatment decisions,” said Joseph Germino, M.D., Vice President of Medical Affairs, Oncology at Bayer. “Bayer is providing the Test4TRK program as part of our continued efforts to empower the community and help increase the accuracy of cancer diagnoses to improve patient outcomes.”

About the Test4TRK Program
Test4TRK is a Bayer-sponsored program offering laboratory testing for NTRK gene fusions (histology and molecular subject to tissue availability) at no cost to eligible patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). The test results provide information on whether the tumor harbors an NTRK gene fusion to aid in the treatment decision. Bayer will cover the full cost of the test regardless of the test results, treatment decision and patient’s insurance coverage for up to 500 patients in the U.S. Bayer will not cover the associated costs of extracting a viable tumor specimen. For more information, visit www.Test4TRK.com.

About Genomic Cancer Testing
It is important for patients diagnosed with cancer to discuss genomic cancer testing with their healthcare provider (HCP). Genomic cancer testing can identify DNA alterations, or changes, within cancer cells that determine how a tumor behaves or why it grows.4 Genomic cancer testing may help HCPs match patients to approved or investigational therapies based on the specific alteration identified.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

About NeoGenomics
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, Fresno 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. For additional information about NeoGenomics, visit www.NeoGenomics.com.

© 2020 Bayer
BAYER and the Bayer Cross are registered trademarks of Bayer and Test4TRK™ is a trademark of Bayer.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:
1 Amatu A, Sartore-Bianchi A, Siena S. NTRK gene fusions as novel targets of cancer therapy across multiple tumour types. ESMO Open 2016;1:e000023. doi:10.1136/esmoopen-2015- 000023.
2 Cocco, E, Benhamida, J, Middha, S et al. Colorectal Carcinomas Containing Hypermethylated MLH1 Promoter and Wild-Type BRAF/KRAS Are Enriched for Targetable Kinase Fusions. Cancer Res 2019;79(6):1047-1053. doi:10.1158/0008-5472.CAN-18-3126.
3 Van der Tuin K, Ventayol Garcia M, Corver W E, et al. Targetable Gene fusions Identified in Radioactive Iodine Refractory Advanced Thyroid Carcinoma. Eur J Endocrinol. 2019;180(4):235-241. doi:10.1530/EJE-18-0653.
4 Cancer Treatment Centers of America. Advanced genomic testing. https://www.cancercenter.com/treatment-options/precision-medicine/advanced-genomic-testing. Accessed March 2020.
5 Boland GM, Piha-Paul SA, Subbiah V, et al. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. 2015;6(24):20099-20110.
6 Massard C, Michiels S, Ferte C, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 trial. Cancer Discov. 2017;7(6):586-595.
7 Vaishnavi A, Le AT, Doebele RC. TRKing Down and Old Oncogene in New Era of Targeted Therapy. Cancer Discov. 2015;5(1):25-34. DOI:10.1158/2159-8290.CD-140765.

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