Biomarker testing is a critical part of cancer care

All of us involved in cancer research and patient care are gratified to see the growing public awareness of the remarkable advances underway in the fight against cancer. Cure rates for newly diagnosed cases are improving for many cancers, with an expanding emphasis on minimizing the side effects of the treatments needed to accomplish these cures. Moreover, many people whose cancers have spread to other parts of their bodies are living longer and better lives, as cancer becomes more of a chronic disease than a death sentence.

It is important to recognize that an essential reason for these transformations is an explosion of scientific discoveries regarding DNA mutations and other molecular changes that allow cancers to grow and spread. We use this information — called biomarkers — to inform us about prognosis, which medicines to use (or not use), when to change treatments, and for other reasons.

Precision medicines that target specific biomarkers have now joined or replaced more nonspecific and hence, more noxious older drugs that are less effective and have worse side effects. In 2000, only 15% of clinical trials of new cancer drugs involved biomarkers. In 2018, this grew to 55%. Almost two-thirds of anticancer medicines approved by the U.S. Food and Drug Administration in the last five years require biomarkers for their proper use.

It is impossible to conceive of truly modern cancer care in the absence of biomarkers. In breast cancer, we routinely need information about such genes as PI3K, ESR1, and HER2 to know how to treat our patients. In lung cancer, knowledge of changes in eight specific genes is required to choose from the 21 medicines the FDA has approved to treat cases with specific abnormalities.

Biomarker testing also has become critical for managing diseases other than cancer, including many forms of arthritis, autoimmune diseases, and soon, diseases of the brain and heart. Since cancer patients are now living longer — there has been a one-third reduction in the death rate since 1991 — they are prone to such problems as are people without cancer.

Yet, despite mounting evidence of its benefits, appropriate biomarker testing of tumor tissue and blood is currently unavailable to many New Yorkers who could benefit. A recent study published in Personalized Medicine found that 32% of New Yorkers are covered by health insurance plans that have more restrictive coverage than what is currently recommended by guidelines set forth by the National Comprehensive Cancer Network for advanced breast, lung, melanoma, and prostate cancers. Furthermore, a 2021 study showed that 66% of oncology providers across the U.S. reported that a lack of insurance coverage is a significant or moderate barrier to appropriate biomarker testing for their patients.

As a cancer doctor for more than 40 years, I have seen many people struggle to pay for necessary tests or — even worse — not be able to afford tests that could guide them to more effective and less toxic treatments.

All New Yorkers should be able to benefit from biomarker science, which is central to the revolution now happening in all modern medicine. Fortunately, New York lawmakers have addressed the lack of access to biomarker testing this by passing legislation with near-unanimous, bipartisan support in both the State Senate and Assembly that seeks to expand insurance coverage of scientifically proven and medically appropriate biomarker testing. Those of us on the front line of health care implore Gov. Kathy Hochul to sign it into law.