The pharmaceutical industry’s investment in personalized medicine has jumped almost 90% in the last five years. Developers of diagnostic tests, many with FDA approval of their diagnostic devices, are working with pharmaceutical companies to codevelop drugs and companion diagnostics. This may speed up FDA approval of drugs, as the best-suited patients can be selected for clinical trials. Companies are working on diagnostics using liquid biopsies and are developing multiplex NGS panels to simultaneously provide information on several biomarkers. FDA approval of a developer’s NGS platform is sufficient for use with multiple tests. Unresolved issues associated with companion diagnostics include regulations of clinical trials with NGS tests and reimbursement for diagnostics by health care providers. The companion diagnostics market is expected expand more than 20% annually.

Source: Chemical & Engineering News