Red Thread™ To Simplify Cut-Point Analysis for Immunogenicity/ADA Studies

Red Thread™ To Simplify Cut-Point Analysis for Immunogenicity/ADA Studies
October 30, 2020 Ariadne Solutions

LAWRENCE, K.A., October 30, 2020  ̶  Ariadne Software continues its journey to simplify the most challenging areas of bioanalysis by announcing the launch of its new Red Thread™ module for Immunogenicity/Anti-drug Antibody (ADA) cut-point analysis for biologics. Ariadne Software uses the power of expert systems to simplify and automate the tedious, time-intensive and complicated process of analyzing cut-points for ADA studies.

“Due to the nascency of immunogenicity and recent introduction of limited guidelines for analysis of immunogenicity data, there is much confusion in interpreting the guidance to set up cut-point for ADA studies” said Stephanie Pasas-Farmer, Founder and President of Ariadne Software. “This problem is worsened by the disconnect among the scientists who design the experiment and the statisticians who study and analyze the data in absence of context. Through Red Thread, we are trying to bring together the bioanalytical expertise and transparency in cut-point analysis of ADA studies, while maintaining consistency in protocols and processes and allowing for an increase of much needed oversight throughout the program.”

Red Thread can be a force multiplier that, when combined with bioanalytical expertise, can quickly detect trends of importance or any compliance issues. Thus, allowing your bioanalysis team to efficiently focus on resolving critical issues rather than spending time on manual input and review of the data. Red Thread’s current offerings include PK method validation and PK sample analysis for both small and large molecules, as well as immunogenicity cut-point analysis for biologics. Designed for bioanalysts, quality control groups, quality assurance teams, and laboratory management, Red Thread was developed in compliance with both FDA and EMA guidances and best practices.

About Ariadne Software

Ariadne Software applies artificial intelligence solutions to bioanalytical data to accelerate data review and offer unprecedented levels of sensitivity and granularity for precision bioanalysis. The company was founded on the belief that the right tools paired with bioanalytical expertise can assist biopharmaceutical scientists to better identify and predict risk early in drug development, while accelerating drug development timelines and delivering treatments to the patients who need them most.


Stephanie Pasas-Farmer
Founder and President