MAR, 2015

FDA’s Role In The Precision Medicine Initiative Pushes Combination Drug Devices to New Heights Sharing Cognos Therapeutics’ Vision.

Most medical treatments are designed for the “average patient” as a “one-size-fits-all approach”, that is successful for some patients but not for others. Precision medicine, sometimes known as “personalized medicine” is an innovative approach to disease prevention and treatment that takes into account differences in people’s genes and other biological attributes, environments and lifestyles. Cognos Therapeutics’ Sinnais smart implantable pump provides an alternative choice that enables drug innovators to customize precise drug dosages to each patient’s specific treatment needs by using drugs to be a companion drug with Sinnais (a combination product).

In an article from the National Center for Biotechnology Information, a division of the NIH’s U.S. National Library of Medicine, the growing role of Companion Diagnostics is discussed. As currently defined, Companion Diagnostics is the use of diagnostic testing being simultaneously run during the application of drug-based therapeutics in order to determine the drug’s  applicability and efficacy to a specific person or people group. The companion drug with diagnostic device, combination product, drug delivery is becoming more prevalent, and in some cases mandated, as new advanced therapeutics are being brought online. This is especially true when it comes to targeted chemotherapeutics such as Herceptin® (trastuzumab) and Gleevec® (imatinib), which both require testing with companion diagnostics before they can be prescribed.

Cognos Therapeutics’ Sinnais smart implantable pump provides physicians real-time diagnostic feedback on an administered therapeutics effect on a targeted disease site, but also the important patient vitals that would be required for Companion Diagnostic testing.

Read Article on NCBI Site