Medical Device Link.

This editor’s page features comments by Glen P. Freiberg, president of RCQ Consulting (San Diego) and a member of IVD Technology’s editorial advisory board, on the 21st Century Cancer Access to Lifesaving Early Detection, Research, and Treatment (ALERT) Act:

The ALERT Act is intended as a comprehensive approach to cancer prevention, detection, research, and treatment. Historically, it has been a challenge to obligate insurers to allow coverage for preventive tests, so the government often took on this challenge piecemeal, such as with breast and cervical cancer. In my past discussions with legislators, there has also been recognition that federal spending is a divided-up pie, and seeking increases in targeted spending based on later savings has not been a budgetary approach.

Now with the ALERT Act, the topic truly has a comprehensive approach. Where this has the potential to affect IVD manufacturers most quickly is in the expansion of therapeutic companies’ investments in diagnostics paired with therapies. The IVD industry has already seen such an approach with Her-2 and Herceptin, gene rearrangement tests for leukemia, and in genetic-based therapies. In fact, the earliest applications of analyte specific reagents (ASR) and the primary driver for the ASR regulation was the use of monoclonal antibodies to help pathologists classify hematoxylin- and eosin- positive slides.

As with all major legislation, working out the details via regulation and affiliated guidance will be difficult and time-consuming. Still, there are high potential aspects for IVD manufacturers in the proposed legislation. For example, section three adds a new entity within the National Cancer Institute to support an interconnected network of biorepositories with consistent, interoperable systems for collection, storage, annotation, and information sharing. If this new entity can provide the opportunity for banked sample sharing, data accumulation for an FDA submission can be accelerated since securing the target samples is a major gating factor for any IVD clinical trial.

The bill’s authors recognized this sample collection hurdle by including a requirement that caregivers ask for samples. The legislation “requires hospitals and ambulatory care centers that receive federal funds to offer patients the opportunity to contribute their biospecimens and clinical data to a clinical registry.” This requirement may complicate the consent paperwork procedures and also create competition between IVD manufacturers and the government for samples. But in cases in which newly diagnosed patients are not part of a formal clinical trial, this requirement will be a great source of samples if the appropriate patient data are concurrently collected and provided, and the ability to audit by the sponsor or FDA’s bioresearch monitoring staff is part of the process. Without this data trail, the samples will be less valuable.