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Molecularly-Targeted Cancer Therapy is Here Why is Change So Hard? Advances in DNA Sequencing Technologies • We can sequence DNA 1,000 times faster than just a few years ago, for about the same cost • The technology is robust and highly reproducible between laboratories • Instead of testing 1 to 3 genes in a cancer, we are now testing 20-200 at a time • Sequencing all 20,000 genes in the genome is being performed in some labs and will become commonplace in the near future Clinical Utility of Broad-based DNA Sequencing in Cancer • Our lab conducted a recent study of 301 cases of advanced cancer: • A 37-gene panel was completed on all cases • The results influenced patient care in ~20% of cases • New options included: • Entry into a clinical trial • Use of a targeted therapy off-label • In some cases, a decision not to use a particular therapy J Clin Oncol 32:5s, 2014 (suppl; abstr 11028) Costs and Reimbursements • The cost for sequencing a panel of 37 genes is only ~4 times the cost of sequencing 1 gene • Most private insurers are reimbursing at ~40-50% of charges, but some pay nothing • However, 45% of patients with the most common cancers are on Medicare • In the eyes of Medicare, only half a dozen genes are relevant to cancer and only these are being paid • New billing codes for gene panels have been created but are not assigned any $$ value Summary • There is an enormous and growing gap between what technology can deliver and what is accepted by payers as ‘standard of care’ • Opportunities to benefit patients with common cancers (e.g. lung cancer) are being missed throughout the country • Laboratories that strive to make state-of-the-art testing available are being financially penalized • The FDA has announced it will begin to regulate all laboratory-developed tests in the U.S., which will add to costs and overall regulatory burden