Breaking Down Barriers – Improving Access to Comprehensive Biomarker Testing for Cancer Patients

This is the first in a series on advances in genomic testing and the future of cancer treatment.

The last two decades have brought remarkable advances in cancer treatment with the use of precision medicine. Twenty years ago, the major weapon doctors had against most advanced cancers was a harsh regimen of chemotherapy — a one-size-fits-all treatment that leaves patients debilitated while offering limited survival.

The shift to more targeted treatments began after researchers discovered that many cancers are driven by mutations in specific genes. This was most robustly exemplified in non-small cell lung cancer (NSCLC). Pharmaceutical companies have now developed more than two dozen drugs for patients with NSCLC that directly target specific genes and mutations, leading to better overall outcomes.

The impact of these advances “has been enormous,” says Dr. Wendy Levin, Chief Medical Officer at Biofidelity, a cancer diagnostic company. “If we can get a patient on a targeted agent that’s more effective and better tolerated, we know that they will have a major survival advantage.”

Barriers to Biomarker Testing

For any cancer, selecting an appropriate targeted treatment requires molecular testing of the tumor to identify possible actionable biomarkers and their associated therapeutics — essentially an individualized cancer treatment roadmap. In the case of lung cancer, the majority of diagnosed patients have genetic mutations with known treatments1-4, and guidelines from the National Comprehensive Cancer Network (NCCN) recommend testing for all advanced patients diagnosed with NSCLC.5

Unfortunately, there are several barriers that prevent a majority of patients from accessing comprehensive biomarker testing — an issue that isn’t unique to lung cancer.  In fact, fewer than half of metastatic cancer patients in the United States who could benefit from targeted therapy actually undergo molecular testing to guide their treatment — and the percentages are much lower in many countries around the world.6

Complex, Costly and Slow

One barrier is the significant gap that exists between the current testing options. On one hand, real-time PCR is relatively fast and available in every hospital but narrow in scope. It can only test at most a few genes at a time, an especially limiting factor for cancers associated with multiple actionable genes and mutations.

On the other hand, next-generation sequencing (NGS) provides a wealth of information, but the reports are overly complex and much of the information isn’t even actionable. At around $5,000 per test, NGS is also expensive and “requires a sizable investment in bioinformatics and machinery, as well as clinical and technical specialized expertise, such that it’s only available at a few academic medical centers, or commercial companies,” Dr. Levin explains. And some oncologists, especially in smaller community-based cancer centers, may not be aware of the opportunities or have the resources to take advantage of them.

Every patient deserves to have the very best therapeutic treatment options.”

Wendy Levin, MD, MS
Chief Medical Officer, Biofidelity

Additionally, results from NGS testing typically take five weeks from the time a biopsy confirms a cancer diagnosis to the time a patient starts therapy — a long time to wait for a treatment plan.

“When presented with a devastating diagnosis, waiting for five weeks is challenging on many levels, for both patients and their families, ” says Dr. Levin.

Sometimes the cancer is so aggressive that waiting five weeks could be fatal, forcing doctors and patients to make the agonizing decision to start immediate chemotherapy prior to receiving biomarker data, despite the potential high risks and low benefits.

Fast, Inexpensive, Actionable – Just Right?

What’s vitally needed, therefore, is a new testing approach that’s fast and inexpensive, getting results within days instead of weeks for hundreds of dollars or less. That’s the technology that Biofidelity has developed and is now in the process of proving its benefits to doctors, medical centers, patient groups, and pharmaceutical companies.

“It’s an absolute game-changer for the field of oncology and closing this huge gap in testing,” says Dr. Levin. “Every patient deserves to have the very best therapeutic treatment options.”

Next in the series:
Knowledge is Power – Why you should #KnowYourBiomarker


  1. Nyberg K. Broad molecular testing in lung cancer: the struggle to translate recommendations to clinical practice. International Association for the Study of Lung Cancer. Published June 24, 2020. Accessed Sept. 23, 2021.
  2. Jordan EJ, Kim HR, Arcila ME, et al. Prospective comprehensive molecular characterization of lung adenocarcinomas for efficient patient matching to approved and emerging therapiesCancer Discov. 2017;7(6):596-609.
  3. Nadler E, Espirito JL, Pavilack M, Boyd M, Vergara-Silva A, Fernandes A. Treatment Patterns and Clinical Outcomes Among Metastatic Non-Small-Cell Lung Cancer Patients Treated in the Community Practice SettingClin Lung Cancer. 2018;19(4):360-370.
  4. Gutierrez ME, Choi K, Lanman RG, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunitiesClin Lung Cancer. 2017;18(6):651- 659.
  5. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer (Version 5.2021). Accessed Sept. 23, 2021.
  6. Chawla A, Peeples M, Li N, et al. Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers. J Med Econ. 2018; 21(6), 543-552.

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