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Rebecca S. Eisenberg Robert & Barbara Luciano Professor of Law University of Michigan Law School Opting for Regulation When Patentability Is In Doubt New technologies have dramatically reduced the cost of DNA sequencing, making it feasible to use genetic testing to select the most appropriate treatment for each patient. But recent judicial decisions have cast doubt on the patentability of the DNA sequences and interpretive algorithms that make up these new diagnostic tests, threatening to undermine investment incentives for this promising field of research. On the other hand, FDA has so far allowed most laboratory-developed diagnostic tests to be sold without regulatory approval. Perhaps by avoiding this regulatory burden, test developers can survive without patents. Surprisingly, however, some test developers are forgoing this regulatory break and instead opting to pursue approval that the FDA does not require. This episode may illuminate the complex strategic considerations that innovators face in navigating the intersection of patents, regulatory approval, and insurance coverage for new health-related technologies.