New targeted therapy approvals are occurring at a rapid pace, but a growing number of patients are still receiving chemotherapy instead of personalized therapies as first-line treatment. Despite all these advances, not all patients have access to personalized treatment. To enable the effective adoption of precision oncology in cancer treatment, next-generation sequencing is needed.
Compared to traditional methods, NGS offers advantages in terms of precision (sensitivity and specificity) and speed which have the potential to have a significant impact on the field of oncology. Since NGS can assess multiple genes in a single test, it eliminates the need to perform multiple tests to identify the offending mutation.
The National Comprehensive Cancer Network (NCCN) guidelines recommend testing 10 specific biomarkers before starting treatment for non-late stage lung cancer (NSCLC), with an emphasis on EGFR in exons 19, 20 and 21. Other guidelines call for testing six biomarkers in colon cancer, including KRAS / NRAS and BRAF mutations, as well as HER2 amplifications and high repair status / mismatch (MMR) of microsatellite instability ( MSI) in people with metastatic colorectal cancer.
With targeted therapies becoming the new standard of care in oncology, companion diagnostics based on the NGS are widely regarded as determining the selection of treatments to optimize patient outcomes in the future. In addition, NGS was applied to sequence circulating tumor DNA (ctDNA) in the area of liquid biopsy. Since cDNA is made up of the DNA fragments released by tumor cells, it can provide a molecular profile of cancer. Liquid biopsy can be applied at all stages of cancer diagnosis and treatment, allowing non-invasive, real-time monitoring of disease development.
The use of NGS presents several challenges that will need to be addressed, especially for the community-based oncology practice where most patients reside. Streamlining NGS as well as interpretation and clinical genomic reporting, especially for sophisticated panels, remains time consuming and difficult. Other major limitations of genomic testing relate to the quality of the starting material for testing, the ability of a given sequencing method to generate usable results with the tissue sample, and the complex workflow involved in performing an NGS test. Cost is another concern and access in some areas.
At last year’s American Association for Cancer Research conference on the science of cancer health disparities among racial / ethnic minorities and medically underserved people, a study showed that molecular testing was less common among historically underrepresented groups, older patients, and those uninsured or insured by Medicaid. the patients.
In August, health plans regulated by the state of Illinois will cover biomarker testing from 2022. Biomarker testing, the medical technology used to determine medical risk factors like cancer, will now be covered by Medicaid as well as by state regulated insurance plans. Now, Illinois patients will be able to benefit from personalized therapy without worrying about the cost with biomarker testing, to help determine the right treatment at the right time to improve patients’ quality of life.
But how do you ensure that this model is adopted in every state, city and hospital in the United States? The goal is to provide clinicians with high quality, accurate and cost-effective IVD tests to enable better treatment decisions for cancer patients. Pillar’s automated primer design software, single tube lab workflow, and bioinformatics analysis platform provide a unique solution. Streamlined workflows are important, so testing can be performed by any lab that performs NGS testing. Affordable tests increase patient access, to provide the rapid turnaround time needed to guide physicians’ treatment decisions.
According to the National Cancer Institute, in 2020, around 600,000 people died of cancer. The most common cancers are breast cancer, lung and bronchial cancer, and prostate cancer. The hope is that with personalized medicine, more patients will have a better chance of beating cancer.
With these new technologies and emerging products, equity of care and access is important. Molecular testing should be available to all patients and much remains to be done. There are disparities between comprehensive cancer centers and community center hospitals, but each hospital and CLIA lab should all be eligible to perform NGS tests closest to the patient’s place of residence.
This hospital-based NGS test model enables the adoption of personalized medicine across a patient’s continuum of care. We need to create an inclusive standard of care, where all patients have access to personalized therapy.
Gang Song, Ph.D., is the Founder, President and CEO of Pillar Biosciences, which co-invented Pillar Biosciences’ SLIMamp technology. He subsequently co-founded Affyimmune Therapeutics, a cellular immunotherapy company, and is also a venture capital partner at ORI Capital. Previously, Dr Song held positions of increasing responsibility at LabCorp (formerly Genzyme Genetics) and IQuum (subsequently acquired by Roche Molecular Diagnostics). Dr Song completed his postgraduate training in Timothy Springer’s lab at Harvard Medical School and received his doctorate. from Shanghai Medical College of Fudan University, China.