Sample sets that were originally screened with high content microarrays during discovery are re-analyzed with new batch of test and control sample sets using Althea’s proprietary multiplex XP-PCR technology.  The targeted multi-gene panels of 20-40 genes are then qualified as a Biomarker based on established assay performance guidelines and overall study design. 

Qualified biomarkers are then validated by running a statistically significant amount of previously untested samples against the verified biomarkers.

Detailed Standard Operating Procedures (S.O.P.) are established before the release of validated biomarkers into clinical trials, where Althea’s in-house experience and QA/QC expertise will perform all testing under GLP guidelines.  Our laboratories have conducted over 300 GLP studies, and we are currently engaged in multiple clinical trials with our clients.