Personalized medicine has the potential to radically reshape the clinical and diagnostic space. As diagnosis moves from relying on global and national statistics to incorporating relevant risk statistics, personalized medicine represents the the next great advance by enabling the ability to understand and respond to a patient's own personal biology.

Personalized medicine will be empowered when the key drivers - clinical, regulatory, and research groups - are better able to communicate what needs to be done and how to meet those needs. The BioCompute standard opens efficient lines of communication between the research and clinical groups who identify, research, and diagnose illness. BioCompute further connects the biotech, pharmaceutical, and FDA groups concerned with the development, deployment, and regulation of biomedical insights.

High Throughput Sequencing in the clinical space

Personalized Medicine is used to refine therapies and predict efficacies. Already, there are more than 140 FDA-approved drugs on the market with pharmacogenomic information, and it is estimated that 5% of all medication prescribing will be checked for appropriateness with genomic data. Both of these numbers will likely continue to grow as more information is learned. For a patient and her physician to know what indications her genome has, a standardization of the pipeline used to derive the biomarkers will be tremendously empowering.

An average of 10 new genetics tests are introduced to the market every day over the last 4 years. Because the steps involved in generating a test with genetic data are often proprietary, the tremendous insights offered by these tests are often siloed.

If more information becomes available in the future or if there’s a need to share the analysis with another clinician or researcherfor any reason, the review can often be confusing and inaccurate, and lead to the inability to reproduce the same results, or a paintaking and time consuming process of recreating what was done and troubleshooting the analysis. Additionally, if a patient simply wants to take a second genetic test, often they’ll have to start over and take another test. The effort invested in collecting, sequencing, and analyzing DNA many times cannot be reused for future tests.

Standardization of pipelines in the clinical space will also make possible independent validation of clinical tests. While current tests are often validated internally, it is not possible to verify tests against a common standard.

If you’d like to explore membership or learn more about the program, please contact us. More information about BioCompute is available on the OSF webpage.