[gdpawel]

Sarah

Every test does not cost about $6,000 per patient. The cost varies anywhere from $2,500 to even $6,000, depending on the amount of drugs being tested. It is the cost of the drugs that are the real expense in doing this testing. But the cost pales in comparison to ineffective trial-and-error treatment.

The "standard" of care is to give the drug(s) with the least resistance and/or the drug(s) with the most sensitivity. By having additional support of drug patient-specific activity, as determined by extensive laboratory pre-tests to improve patient outcomes, could very well bolster a doctor's argument for using some these drugs (even if it would show some less expensive drugs).

It does amaze me not only that some private insurance carriers do not like to pay for these tests but that they don't emphatically mandate it as a requirement for obtaining chemotherapy reimbursement against ill-directed treatments. Even the "profit" motive of private insurers is entirely consistent with the goal of the tests, which is to identify efficacious therapies.

It really annoys me that the validation standard that private insurance companies are accepting from molecular (genetic) profiling tests is accuracy and not efficacy. No longer is it essential to prove that the use of a diagnostic test improves clinical outcomes, all they have to do for these molecular profiling tests is prove that the test has a useful degree of accuracy. Accuracy is the exact same standard functional profiling is judged on (no different). They have the same entitlement to be judged by the same validation standard. It must be noted that all types of diagnostic tests in cancer medicine are just that, "tests" and not treatment.

In the first head-to-head clinical trial comparing molecular profiling with functional profiling, functional profiling was found to be substantially more accurate (Arienti et al. Journal of Translational Medicine 2011, 9:94 doi:10.1186/1479-5876-9-94). It is hoped that some form of clinical trial like this would happen here in the US this year. Perhaps a good three-armed clinical trial: physician's choice vs molecular profiling vs functional profiling?

Greg