Comment Paper on test by Harvard, Stanford, Yale, Counsyl (Score 1) 4
Hey -- Counsyl person here (colleen_at_counsyl_dot_com). Wanted to make a few quick points
1) The key precedents for what we're doing are the Jewish community's successful campaign for universal Tay-Sachs screening and the at-home pregnancy test. Please see blog.counsyl.com for more details!
2) If anyone is curious about the paper mentioned in the article, it is available in advance of publication at Nature Precedings. Authors are from Harvard, Stanford, Yale, and Counsyl:
http://precedings.nature.com/documents/4192/version/1
3) We have CLIA certification, the same as the millions of lab tests performed each year by Labcorp and Quest. FDA regulation primarily applies to implantables and drugs, while CLIA applies to tests that have an experienced laboratory scientist in the loop.