Genomic testing is a great way to learn not just about your genes, but how your genes impact your health. In support of the Phase 2 CRESTONE clinical trial, a new partnership between biopharmaceutical company Elevation Oncology (“Elevation”) and NeoGenomics, Inc. is now offering expanded access to genomic testing. The pair’s press release highlights how the testing aims to identify patients with NRG1 fusion solid tumors so that they have the opportunity to participate in the clinical trial.
Genomic Testing
According to the Dana-Farber Cancer Institute:
Genomic testing, a newer field to genetics, refers to the process of observing an entire genome (genes that make up an organism) of an organism; for example, the human body. A person has about 25,000 different genes that are made up of about 3 billion DNA units.
While genetic testing focuses on finding one or two specific gene mutations, genomic testing explores all genes and potential mutations. Identifying the specific genomic issue associated with a solid tumor can help achieve precision care. In this case, patients would be in good hands. NeoGenomics provides over 50,000 next-generation sequencing tests each year.
NRG1 Fusions
So what exactly are NRG1 fusions – or gene fusions in general? ScienceDirect explains that gene fusions occur when two previously independent genes “fuse” together, forming somewhat of a chimeric gene. These genes also produce fusion proteins. On the CRESTONE study website, it shows that:
NRG1 is an abbreviation for neuregulin-1 (sometimes also called heregulin), and may refer to either the NRG1 gene or the NRG1 protein. Healthy cells throughout the body use the genomic information in the NRG1 gene to create NRG1 proteins, which perform a wide variety of functions and are essential for normal development of the nervous system and heart.
However, once these fusions occur, they can activate the HER3 pathway and promote tumor growth. Now, NRG1 gene fusions have been discovered to play a role in more than 10 solid tumor types, including:
- Pancreatic cancer
- Breast and ovarian cancer
- Colorectal cancer
Genomic Testing & The CRESTONE Study
Currently, the expanded genomic testing is designed to find patients who might qualify for the Phase 2 CRESTONE trial. During the trial, researchers will evaluate seribantumab for a variety of NRG1 fusion solid tumors. This fully human IgG2 monoclonal antibody binds to HER3 and inhibits its ability to activate and prompt cell proliferation. So far, around 847 patients have received seribantumab.
Researchers are searching for patients who have not previously received genomic testing or who have a solid tumor that is not responding to, or has not previously responded to, treatment. In addition to searching for NRG1 fusions, the tests will also look for other fusions such as ROS1, RET, and NRG1, among others.
If patients enroll in the study, they will receive seribantumab. Researchers seek to understand its safety, efficacy, and anti-tumor activity. Interested in learning more? Check here.
