Are cancer biomarker tests grossly underused?

A cadre of researchers, academics, insurers and patient advocates are calling for major reform in how tumor biomarker tests are regulated, reimbursed and developed. They argue that the current system leaves the diagnostic tools chronically underused and holds back the advance of personalized cancer care.

"Right now, biomarkers are not valued nearly to the extent that we see with therapeutics. But if a tumor biomarker test is being used to decide whether a patient should receive a certain treatment, then it is as critical for patient care as a therapeutic agent," Dr. Daniel Hayes, director of the University of Michigan Comprehensive Cancer Center, said in a statement.

Hayes is lead author of a commentary paper published in the journal Science Translational Medicine that outlines the argument for change. A number of authors also participated, including experts from the University of North Carolina School of Medicine, the University of Vermont College of Medicine, UnitedHealthcare, the American Society of Clinical Oncology, the Center for Medical Technology Policy and Veridex, a Johnson & Johnson ($JNJ) division focused on in vitro diagnostics.

A biomarker test has broad potential. It can help screen for cancer patients with a particular gene mutation, for example, who might benefit from a drug that can target tumors with that unique genetic subset. Similarly, it can help identify patients who won't respond to a given drug, reducing the unnecessary use of a costly drug that won't work. But the study authors say that poorly funded tumor biomarker research, insufficient insurance reimbursement and "inconsistent" regulations hold back their broader use, stunting the full potential of cancer biomarker tests. They want a biomarker test process as robust as what exists for the never-ending drug pipeline--an "even playing field," if you will, that accounts for everything from investment to regulatory approvals.

To get there, they propose a reform of the regulatory review of tumor biomarker tests. As well, they urge higher insurance reimbursement to propel increased use of tests proven to work and advocate more investment into tumor biomarker research to bring it up to drug industry levels. These last two goals are particularly pointed, considering how intertwined they are. Venture investment in diagnostic tests, for example, has plunged in recent months, in part because companies have found it increasingly difficult to obtain CMS or private insurance coverage for their tests once they are approved. Addressing insurance reimbursement alone could open up the funding spigot for promising diagnostic tests in the pipeline.

As well, the authors are pushing for a more rigorous peer review of tumor biomarker publications to promote better scholarship, and they also recommend including only biomarker tests proven to work in evidence-based care guidelines.

Hayes himself has a unique perspective on the whole issue. He's a researcher and has several cancer biomarker patents. And as the University of Michigan Comprehensive Cancer Center discloses, he's also consulted for the industry and received funding from companies including Novartis ($NVS), Veridex/J&J and Janssen.

- read the release
- here's the journal abstract