not back by much data. Despite deCODEme's emphasis that its results were for informational purposes — "a roadmap to improve your health" — and the provision of genetic counseling for users who had questions about their results, US regulators quickly took a critical view of disease risk assessments being put directly in the hands of consumers. In June 2010, the FDA wrote to deCODE and its main competitors to say that they considered such scans to be medical devices requiring FDA approval. Facing regulatory headwinds and then corporate reorganization, deCODE stopped selling deCODEme in late 2012. In 2017, the FDA began to approve certain assessments of genetic risk for disease in consumer tests. In 2018, deCODE broke new ground with a direct intervention in public health and the first national genetic screening program of its kind. The company launched a website that enables anyone in Iceland to ask the company - free of charge - to search their whole genome sequence data to determine whether they are likely carriers of a SNP in the BRCA2 gene that confers high risk of breast and prostate cancer in Iceland. Within months, ten percent of the population had requested their BRCA2 status, and the National Hospital has built up its counseling and other services to help people follow up on their preliminary results and use the information to protect their health. Business Despite its pathbreaking science, or perhaps because it was often far ahead of the field, deCODE had a volatile history as a standalone business. In July 2000, it completed a $200 million IPO on Nasdaq, big for the time and the first listing by an Icelandic company on a US exchange. Its early pharmaceutical alliances, particularly that with Roche, further helped to fund the enrollment of most of the adults in the country in the first decade of its research, and the rapid expansion of both its discovery capabilities and its product development efforts in drugs, diagnostics and personal genomics. From a scientific perspective, as the Broad Institute's David Altschuler told the MIT Tech Review in 2004, "This is a business in which critical mass is important, and they have achieved critical mass." But the business was also about money. Being an innovation enterprise pioneering new markets, the company had spent more than $500 million on R&D in its first decade and never been profitable. By 2006 it was borrowing more,