The Life Raft Group (LRG) is providing you with this information to let you know that comprehensive genomic profiling, also known as biomarker testing or molecular testing, is a crucial step in understanding the genomic factors that play a role in a GIST diagnosis.

Bayer Pharmaceuticals, working with The Life Raft Group (LRG), has extended a research collaboration to broaden access to comprehensive genomic testing for Gastrointestinal Stromal Tumor (GIST) patients. This collaboration aims to advance precision medicine in oncology and use comprehensive genomic testing to identify patients in the United States (U.S.) who may benefit from may benefit from personalized care.

Comprehensive genomic testing, also known as biomarker testing or molecular testing, is a crucial step in understanding the genomic factors that play a role in establishing a GIST diagnosis. There are different types of comprehensive genomic testing: the most common tests are basic mutational testing and advanced next-generation sequencing. These tests may help identify alterations, or changes, within DNA and/or RNA of cancer cells that determine how a tumor behaves or why it grows. Basic mutational testing focuses on testing specific genes like c-KIT, PDGFRA, and BRAF. Advanced next-generation sequencing may test a broader range of genes, usually between 5-500+ genes, including neurotrophic tyrosine receptor kinase (NTRK) gene fusions. The results can help healthcare providers match patients with available treatment options or clinical trials. Finding the right therapeutic can be a turning point in the treatment journey of a GIST patient.

GISTs are a type of soft tissue sarcoma – cancers that develop in connective or supporting tissues – that affect an estimated 3,000 to 5,000 people in the U.S. each year. One genomic alteration that can drive the growth and spread of GIST is called an NTRK gene fusion. There are currently treatments for GIST driven by NTRK gene fusions approved in the U.S.1

Criteria for patients to participate in this program includes: be a U.S. resident, be or become a part of the Life Raft Group GIST Patient Registry, have a treating oncologist, must not have had any type of prior comprehensive genomic testing (basic mutational testing or next-generation sequencing), or have previously been identified with wildtype c-KIT or PDGFRA results from basic mutational testing. This collaboration is an example of the vital role patient advocacy groups play in bridging the gap between researchers and motivated patient populations willing to be part of innovative studies.

“As part of our commitment to precision oncology, we believe identifying NTRK patients early through comprehensive genomic testing is a critical step in the cancer diagnosis of oncology patients experiencing metastatic disease, as it helps physicians understand the underlying drivers of tumor growth and can inform the treatment approach,” said Iain Webb, M.D., Vice President, U.S. Medical Affairs, Oncology at Bayer. “That is why we are pleased to collaborate with The Life Raft Group to increase the availability of comprehensive genomic testing for GIST patients to potentially uncover NTRK gene fusions and provide options for those who may benefit from precision oncology treatments.”

This collaboration builds on Bayer’s existing commitment to advance precision oncology, which includes research to find targets and pathways that drive cancer growth, and how these findings can impact the way cancer is treated.

“We are excited to be a part of this groundbreaking opportunity to work with great organizations to pave the road towards precision medicine and to help us to reach our goal of increasing the testing rate among GIST patients,” said Denisse Montoya, Patient Registry Director at the Life Raft Group. “By offering comprehensive genomic testing with no charge, many patients will have the opportunity to know what genes are driving their GIST and benefit from genetic-informed care. Results from this testing collaboration will help us understand more traits and patterns within GIST that will help us with our aim of accelerating GIST cancer research.”

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 includes 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 help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

References

1 Life Raft Group. Understanding GIST.

Tissue Testing Protocol

pdf version

The LRG has entered this collaborative research project to optimize access to genomic sequencing for GIST patients. This project aims to increase testing optimization by providing FREE Next-Generation Sequencing (NGS) to eligible patients. LRG has retained Tempus laboratory to provide the testing.

The criteria to participate:
● Must be a US resident
● Must be or become a part of the Life Raft Group GIST Patient Registry
● Must have a treating oncologist
● Must have not had any type of testing (basic mutational testing or advanced testing)
● Patients with wildtype KIT or PDGFRA results from basic mutational testing can also participate

Tempus Tests Available in the Program

xT Solid Tumor + Normal Test

Features:
– 648 gene DNA panel sequenced at average 500x depth of coverage
– Sequencing of FFPE tumor tissue and normal matched (through blood or saliva) specimens; includes reporting of 46 incidental germline findings
– MSI status and Tumor Mutational Burden (TMB)
– Full transcriptome by RNA sequencing w/ validated fusion detection
– Specimen Types:
– FFPE tissue Slides or Blocks
– Normal match (blood or saliva)

xT Tumor Only Test*

*recommended when unable to obtain normal matched specimen or if the normal matched specimen cannot be successfully sequenced

Features:
– 648 gene panel sequenced at average 500x depth of coverage
– Sequencing of FFPE tumor tissue
– MSI status and Tumor Mutational Burden (TMB)
– Full transcriptome by RNA sequencing w/ validated fusion detection
– Specimen Types:
– FFPE tissue Slides or Blocks

Note: Additional tests other than xT are not covered through this program.

Steps to Participate

The Life Raft Group will reach out to physicians to provide the patient’s LRG Sample ID and the Tempus requisition for the program.

1. Complete the test requisition form provided by The Life Raft Group via email. Submit the requisition form and any accompanying documents via email to, fax 800-893-0276, inside the kit, or via the Tempus Clinical Portal.

    a. To protect patients, please only provide the patient’s LRG Sample ID and Date of Birth.

2. Tempus and The Life Raft Group will manage tumor sample procurement.

    a. Optional: If you would like to send in a matched normal sample, please request a Tempus blood or saliva tissue kit via

support@tempus.com. Following the instructions for use inside the blood sample kit, collect the sample, and submit to Tempus.

3. Await results while Tempus procures specimens, sequences, and generates the patient’s report. Reports are delivered in approximately 10-14 days from the time Tempus has received all the required information and the specimen(s).

Please direct any questions regarding testing or the ordering process to LRGProgram@tempus.com. Please direct any questions regarding The Life Raft Group’s registry and biobank programs to Denisse Montoya, Director of Patient Registry dmontoya@liferaftgroup.org