Developing Biomarker-based Tools for Cancer Screening, by Margie Patlak Sharyl Nass

By Margie Patlak Sharyl Nass

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Extra resources for Developing Biomarker-based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Workshop Summary

Example text

This led to the development of a nonprofit public-private partnership to qualify fluoro‑2‑deoxy-D-glucose (FDG)-PET scanning as a marker for drug response in non-Hodgkin’s lymphoma. These consortia are vital, Dr. Woodcock asserted, because “the availability of biomarkers is a common good. It is good for patients and ­clinicians as well as for researchers and medical-product developers. ” Oversight of Diagnostic Tests Mr. Heller, a partner at Wilmer Cutler Pickering Hale and Dorr, LLP, gave the next talk.

The Task Force recently reviewed the evidence regarding screening for prostate cancer with the PSA test. It gave the use of this test for this purpose a designation of I. Although it found good evidence that screening can detect early stage prostate cancer, there was mixed and inconclusive evidence that such early detection improves health outcomes. In addition, it found very strong evidence that screening and subsequent treatment are both linked to important harms, and concluded that the benefits of treating early prostate cancer are unknown.

Coordinating the Development of Biomarkers and Targeted Therapies Only a fraction of cancer patients will respond to a given cancer ­therapy, with responders being as low as 1 percent for drugs that target WORKSHOP SUMMARY 21 s­ pecific genetic and molecular changes in cancer cells. Such targeted treatments often require biomarkers that can reliably predict patients likely to respond in order to show efficacy in clinical trials, let alone in the clinical setting at large. But development of biomarker-based tests to predict drug responders has lagged and is often undertaken outside of the company developing the drug.

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