America Invents Act

Source for information and real time news on implementation of the Leahy-Smith America Invents Act

Important Dates

  • June 16, 2012 - Study Report Deadline

Genetic Diagnostic Testing


In Section 27 of the America Invests Act, Congress requires the Director to conduct a report in regards to independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.

The AIA sets out four issues the report should address: 1) the impact the current lack of independent second opinion testing has had on the ability to provide the highest level of care to recipients of genetic diagnostic testing and on inhibiting innovation to existing testing and diagnoses; 2) the effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test; 3) the impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine; and 4) the role that costs and insurance coverage has on access to and provision of genetic diagnostic tests.

Upcoming Events/Key Dates

This report was supposed to be submitted to Congress by June 16, 2012, but has yet to be submitted.