Medical Device Link.

Senators Edward M. Kennedy (D-MA) and Kay Bailey Hutchison (R-TX) introduced the 21st Century Cancer Access to Lifesaving Early Detection, Research, and Treatment (ALERT) Act (S. 717), which comprehensively addresses the challenges in battling cancer. This bill is the first sweeping cancer legislation introduced since the 1971 National Cancer Act, which was also authored by Kennedy.

The bill aims to provide critical funding for promising research in early detection, and supply grants for screening and referrals for treatment. Such measures will also ensure patient access to prevention and early detection, which is supplemented by increased access to clinical trials and information.

In addition, the legislation emphasizes strengthening cancer research and the urgent need for resources to prevent and detect cancers at an early stage. The bill strives to give scientists the tools they need to fight cancer and understand more thoroughly how the disease works.

Industry analysts believe that the ALERT Act could affect IVD manufacturers involved in developing cancer diagnostics in a couple of different ways.

“Overall, the bill seems to present important and exciting opportunities for the IVD industry,” said Bradley M. Thompson, an attorney at Epstein Becker & Green (Washington, DC). “One example of such opportunities is the promotion of developments in the areas of oncology research that have great potential to benefit patients and that necessarily implicate diagnostic technologies. Another important example is the bill’s focus on access to biospecimens for research purposes.”

Thompson also pointed out section 13 of the bill, which states that, “It is the sense of the Senate that FDA should integrate policies and structures to facilitate the concurrent development of drugs and diagnostics for cancer diagnosis, prevention, and therapy.” Although the precise impact of this language is unclear, Thompson believes that the intent seems focused on an alignment within FDA in order to promote the development of personalized diagnostics.

“At the same time, though, the IVD industry should also be aware that such opportunities may entail increased government oversight of and input into development efforts and priorities,” said Thompson. “One such example is the postmarket surveillance requirements associated with assessing the quality and accuracy of biomarker tests.”

Other analysts believe that the ALERT Act’s emphasis on early cancer detection and its mandate to such federal agencies as FDA and CMS to facilitate the approval of new screening and diagnostic test technologies could affect the IVD industry’s ability to develop and commercialize new cancer tests. For example, section 7 of the bill specifically requires FDA and CMS to develop guidelines for clinical study designs that, if properly executed, would satisfy each agency’s review requirements.

“One of the major challenges in developing and validating new early detection cancer tests is the existing test standards and practices applied by FDA. Its premarket review processes are often insufficient to validate a sponsor’s claim that their proposed test is indeed an early cancer detector,” says Thomas M. Tsakeris, president of Devices & Diagnostics Consulting Group Inc. (Rockville, MD).

“Another problem is that many new cancer markers fail because their initial promising performance in small-scale studies cannot be reproduced when formal clinical validation studies for FDA purposes are attempted. Moreover, smaller IVD companies with innovative technologies often cannot sustain a failed clinical study that may occur as a result of study design flaws. Hence, guidance provided by regulators if developed properly with public input could be beneficial to sponsors.”

Analysts also commented on certain IVD-specific provisions that should be included in the ALERT Act.

“The bill contains a number of provisions that focus on specific types of research, for example, high risk or translational research,” said Thompson. “Due to diagnostics’ vital role in the diagnosis and treatment of various cancers, the bill should also ideally incorporate specific areas of diagnostics.”

Thompson added that the bill has great potential to ensure that patients receive high-quality treatment for cancer. It should also seek appropriate reimbursement for tests implicated by the new programs.

“The legislation should also ensure transparency and public input in the various processes it seeks to enact,” said Thompson. “For example, this might include input into research funding priorities and the clinical study guidelines to be developed under the bill.”

The ALERT Act can be accessed via the Library of Congress’ Web site at http://thomas.loc.gov/cgi-bin/query/z?c111:S.717: