[gdpawel]

It amazes me not only that some private insurance carriers don't like to pay for oncologic in vitro chemoresponse assays but that they don't emphatically mandate it as a requirement for obtaining chemotherapy reimbursement against ill-directed treatments. Evidence in support of these tests is more than sufficient to justify them.

Profit, as we have seen, is a powerful motivating force. Among the private payors, at least, the profit motive is entirely consistent with the goal of the tests, which is to identify efficacious therapies irrespective of drug mark-up rates.

Everyone is scared to death - and rightly so - at what is going to happen to the healthcare economic system with increasingly expensive new drugs that benefit only a small percentage of patients who receive them. Hence the headlong rush to develop companion diagnostic tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient.

The pressure, in fact, is so great that these molecular companion diagnostics they've approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.

The FDA could benefit too, as they find themselves under increasing pressure to allow new drugs into marketplace while at the same time protecting the safety of potential recipients of those drugs as well as the financial interests of those who will have to pay for them.

I think that in both of these areas - private insurance carriers and the FDA - there is a very real opportunity to make a substantial impact and contribution, an interest in saving the healthcare system perhaps billions of dollars a year by ensuring that expensive treatments are used appropriately.

Committee chairpersons, committee members and persons in congress who may have personal interests not only in discovering new cancer treatments - everybody wants that - but also, in the "here and now," using currently-available cell culture assay technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.

The validaton standard that private insurance companies are accepting from molecular profiling tests is accuracy and not efficacy. The "bar" had been instantly lowered. No longer will it be 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 accuarcy. However, the validation standard wanted for functional tumor cell profiling is efficacy. What's good for the goose is good for the gander.