Development of a Multi-biomarker Risk Score based on Serum Proteins by the Prognostic Lung Fibrosis Consortium

Despite >20 years of IPF biomarker discovery, there are no approved prognostic biomarker tests available for patient stratification or eligibility as a drug development tool. To address this unmet need, the Prognostic Lung Fibrosis Consortium (PROLIFIC) was formed to develop well-qualified biomarker assays, which were applied to large IPF patient serum collections to derive and validate the PROLIFIC Prognostic Risk Score. Rules-Based Medicine, an IQVIA business, developed, validated and manufactured 12 IPF assays utilizing the Luminex xMAP platform for use in IPF trials.

Authors:
Peter Schafer^{1* 13}, John Rassa¹, Agnes Seyda¹, Sarah Hersey¹, Troy Tremaine², Dominic Eisinger^2*, Jenna Melin², Robert Bencher^2*, Margaret Neighbors³, Majd Mouded^4*, Scott Turner^5*, Martin Decaris⁵, Yasmina Bauer^6*, Cheryl Nickerson-Nutter⁷, Dana Ball^7*, Jeffrey Larson⁸, James Swaney⁹, Sharlene R. Lim¹⁰, Andrew Whiteman¹⁰, Alison MacKinnon¹¹, Francesco Marabita¹², Jennifer Mefford13, Scott Staszak¹³, Adam Martin-Schwarze¹⁴, Zheshi Zheng¹⁴, Peter X. Song¹⁴, Joseph A. Lasky¹⁵

¹Bristol Myers Squibb, Princeton, NJ, USA, ²Rules-Based Medicine, an IQVIA business, Austin, TX, USA, ³Genentech Inc., South San Francisco, CA, USA, ⁴Novartis Institutes for Biomedical Research, Inc. Boston, MA, USA, ⁵Pliant Therapeutics, South San Francisco, CA, USA, ⁶Galapagos NV, Basel, Switzerland, ⁷Three Lakes Foundation Trust, Northbrook, IL, USA, ⁸Tvardi Therapeutics, Houston, TX, USA, ⁹Lassen Therapeutics, San Diego, CA, USA, ¹⁰Gilead Sciences, Foster City, CA, USA, ¹¹Galecto Biotech, Boston, MA, USA, ¹²Chiesi Corporate R&D, Solna, Sweden, ¹³Pulmonary Fibrosis Foundation, Chicago, IL, USA, ¹⁴Tulane University School of Medicine, New Orleans, LA, USA, ¹⁵Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA .

^*Affiliation at the time the work was conducted.

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