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Originally Published IVD Technology June 2005
EDITOR'S PAGE
Taking another step
First there was the final guidance on pharmacogenomic data submissions. Now, FDA has followed with a concept paper on drug-diagnostic codevelopment (see this issue’s news story, “FDA Shares Initial Thoughts on Drug-IVD Development,” page 12). By releasing this paper, the agency has continued to make the case that it believes in drug-test combinations and wants to make them work.
It was only a matter of time before FDA made efforts to provide formal guidance
on drug-diagnostic codevelopment. Even though using IVDs for selecting drug treatments has been around for more than 30 years, the agency has cleared very few companion tests that are used for such purposes. However, with escalating costs and shrinking reimbursement budgets, FDA has realized that drug-test combinations could provide huge financial benefits for the entire healthcare system.
From a technological standpoint, pushing through the drug-diagnostic codevelopment concept and working out the fine details should not be too difficult. FDA’s paper does not contain anything that is radically new. For example, the paper reaffirms the principles of analytical and clinical validation, which have been developed during the past two decades.
In addition, there are some successful drug-test combinations on the market, which the agency can use as models. One well-known case in point is
Her-2/neu testing for the breast cancer drug Herceptin.
FDA’s efforts to formalize drug-diagnostic codevelopment come at a time when changes are taking place in the pharmaceutical industry. With megablockbuster drugs no longer a viable option, drug companies are looking to develop more-focused, niche therapeutics that target smaller and more-specific patient populations. But in order to identify those patients who qualify for such drugs, companion diagnostics are needed. Physicians will not prescribe a very specific therapeutic until a test is conducted to determine whether a patient qualifies for the drug. The pharmaceutical industry realizes that more-intense drug-diagnostic codevelopment presents the only workable solution moving forward.
What the paper and eventual guidance on drug-diagnostic codevelopment offer are actual guidelines that will streamline the process and provide a regulatory pathway to market for drug-test combinations. Such guidelines will stimulate growing interest among pharmaceutical and IVD companies, which will lead to increased collaborative efforts and rapid development of such products.
Drug-diagnostic codevelopment benefits everyone and is a better approach to healthcare that is safer and more cost-effective. It is also a golden opportunity that
the IVD industry cannot afford to squander. The industry should take an active role
in pushing this issue forward and should get involved in shaping the policies and standards for this guidance. If using drug-test combinations becomes a standard practice in the healthcare system, there will be great potential for growth in the
IVD industry.
Richard Park
Copyright ©2005 IVD Technology
