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:
— The technology behind rapid, inexpensive testing for cancer mutations
— The view of testing advances from patient advocates and oncologists


  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.

Is it Time to Move Beyond CLABSI?

When it comes to infection control in vascular access, central line-associated bloodstream infections (CLABSIs) certainly get the most attention. Yet the medical community is increasingly recognizing how infections associated with other types of vascular access devices are putting patients at risk.

Take peripheral IV (PIV) catheters, the most commonly used type of vascular access device. Nearly 90 percent of hospitalized patients require a PIV at some point during their stay, and PIV usage far outnumbers that of central vascular access devices (CVAD). PIVs, therefore, account for an infection rate that approaches the CVAD infection rate in absolute terms.

Yet there is currently no mandatory reporting system for bloodstream infections associated with PIVs in the U.S., making it one of the most underreported types of infections in vascular access. Epidemiologist Robert Garcia, an infection preventionist with 40 years of hospital experience, shares these concerns — and he has a plan to address this significant patient safety issue.

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2021 INS Standards Highlight Anti-Reflux Technology for Needleless Connectors

Guest post by Nancy Moureau, RN, PhD, CEO of PICC Excellence

In vascular access, needleless connectors (NC) are now recommended worldwide to maintain closed IV systems and promote safety by preventing needlestick injuries. Over the past 25 years, many different NCs have come onto the market, with wide variations in design and function among the various types. As a result, there is a lot of confusion among clinicians regarding the proper use and management of these small yet complex devices, which can have serious patient safety implications.

Fortunately, the Infusion Nurses Society provides some clarity on this issue by significantly expanding its guidance on NCs in the 2021 Infusion Therapy Standards of Practice. This includes clearer definitions of the various types of NC technology and emphasizes the importance of understanding how to use each type properly to minimize blood reflux.

Many clinicians are not aware of the impact blood reflux can have, or view it as a minor issue that can be easily addressed with proper flushing. However, evidence is mounting that reflux is largely avoidable and leads to many complications that seriously impact patient safety.

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UGPIV Practices: Are they jeopardizing patient safety?

A new continuing education program details how a lack of standardized policies related to ultrasound-guided peripheral IV (UGPIV) catheter insertions can negatively impact patient safety. The webinar also suggests UGPIV performance improvement initiatives that “can help to create a culture of safety across the healthcare continuum,” according to presenter Nancy Moureau, RN, PhD, an internationally recognized expert and consultant in vascular access and CEO of PICC Excellence.

The on-demand webcast, Patient Safety and Ultrasound-Guided Peripheral IV Placement: The Need for Standardized Practices, offers 1 contact hour of continuing education for nurses. It is sponsored by Parker Laboratories.

“While the use of ultrasound guidance to improve success during PIV catheter placements is becoming more common, suboptimal aseptic technique and variations in supply usage poses a very serious risk to patients,” said Dr. Moureau. “To increase safety during UGPIV insertions, healthcare organizations should adopt a multidisciplinary approach to standardize policies and procedures based on current evidence and recommendations, while at the same identifying opportunities for pragmatic, incremental improvements.”

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The Future of Breast Cancer Treatment: Destroying Tumors with a Laser

Breast cancer patients have long been in need of reliable therapeutic options that reduce pain and the risk of disfigurement. At the forthcoming MedTech conference of the Advanced Medical Technology Association (AdvaMed, Washington, DC), laser therapy specialist Novian Health Inc (Chicago) will showcase a novel technology for the ablation of early-stage breast tumors. The company’s CE-marked system is seeking to displace existing surgical procedures as the treatment of choice for early-stage breast tumors.

Every year, more than 275,000 women in the United States and 2 million around the world receive the dreaded diagnosis of breast cancer. The news can be overwhelming, triggering sudden and intense emotions. One participant in a study of patient responses to a breast cancer diagnosis said she felt “paralyzed and frozen with fear.”

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D&D remembers Regis Philbin

While this post is a departure from our usual medicine-focused content, we at D&D wanted to acknowledge the recent passing of Regis Philbin. A few members of our staff were fortunate enough to meet Regis during his 88 years on earth — their reminiscences are below.

From Greg Dennis, retired co-founder of Dowling & Dennis:

Regis Philbin had a son who was confined to a wheelchair and relied upon a small piece of technology made by a large medical company. As it happened, Dowling & Dennis did some PR consulting work for that company.

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COVID-19 and the Importance of Virtual Learning: The Future of Medical Education

When the novel coronavirus began sweeping around the world earlier this year, it left doctors, hospitals and public health experts scrambling for answers. How should diagnoses of COVID-19 cases be made? What are the symptoms that need the most careful monitoring? What are the right treatment options for each stage of the disease? And what happens if patients have other conditions, such as being pregnant? The answers were—and continue to be—evolving so rapidly that it has been hard for overworked physicians, nurses and other healthcare providers to keep up.

But there is one place they can turn quickly for the latest information—a free online training module from a medical education company called CaseNetwork. First released on March 17, this program also illustrates the growing potential of virtual, case-based medical education even long after the pandemic has subsided.

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Protecting Kidney Patients in the COVID-19 World

For the 30 million Americans living with some form of kidney disease, the current COVID-19 pandemic brings a host of additional challenges not faced by the general population—like a greater risk of developing serious complications if they contract the virus. And for the 500,000 Americans with kidney failure who rely on dialysis treatments to stay alive, these challenges only multiply. Do they follow “stay-at-home” orders and skip their dialysis treatments, or do they risk exposure by going to a dialysis clinic where social distancing is difficult, if not impossible, to enforce? Either decision could have life-threatening consequences.

And what about the procedures to create and maintain the necessary access to their bloodstream that makes dialysis possible? In mid-March, the CMS deemed these procedures “non-essential,” leading to a host of cancelled appointments and operations. Even when CMS reversed its decision days later, the confusion that resulted from the chaos left many physicians, hospitals and patients unsure of which path to follow.

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Ensuring Safe Dialysis Access in the COVID-19 Environment

Guest Post by Jeffrey Hull, MD

In the United States alone, nearly half a million people currently suffer from end-stage kidney disease and must undergo hemodialysis several times a week. For these patients, the vascular access site is quite literally their lifeline, as it provides direct access to their bloodstream for the life-saving treatments. 

Yet due to the current COVID-19 outbreak, procedures to establish these vascular access sites have been deemed “non-essential” elective procedures by CMS and HHS, and nephrologists and vascular surgeons are finding themselves unable to secure operating room time.

Though we must all work together during this crisis to reduce the intense strain on our healthcare system, this decision could have devastating implications for patients with end-stage kidney disease — a group that is already highly vulnerable to potential complications of COVID-19. Limiting access to these procedures will increase reliance on riskier vascular access options that significantly increase patients’ chances of infection, hospitalization and even death. This will only add to the strain on resources as hospitals continue to deal with the outbreak.

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Using Liquid Biopsy to Capture Circulating Multiple Myeloma Cells: The Key to Personalized Treatment?

What if you could isolate a single cancer cell from a patient and use its genetic makeup to create a personalized treatment plan optimized for that individual?

That’s exactly what Menarini Silicon Biosystems Inc. (MSB) hopes its technology could one day do for people with multiple myeloma.

Multiple myeloma is the most common hematological malignancy.  It forms in plasma cells, white blood cells found mainly in the bone marrow that protect the body from infection by producing antibodies. When these cells become malignant, abnormal plasma cells accumulate in the bone marrow, producing abnormal antibodies and crowding out normal blood-forming cells. Some of these abnormal cells, known as circulating multiple myeloma cells (CMMC), escape from the primary tumor space and travel through the bloodstream.

Current approaches for diagnosing patients with multiple myeloma require bone marrow aspiration and biopsy. These are invasive procedures that use a hollow needle inserted into the hipbone or breastbone to remove bone marrow, blood, and a small piece of bone. While generally safe, bone marrow exams can result in excessive bleeding, infection, and long-lasting discomfort.

Liquid biopsies, on the other hand, examine cancer-related material from a peripheral blood sample obtained from a simple, common blood draw. MSB has developed a method for enumerating CMMC from liquid biopsies using CELLSEARCH® and DEPArray™ technologies.

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