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TRIKAFTA Drug Monitoring Assay

TRIKAFTA is a combination therapy of the cystic fibrosis transmembrane conductance regulator (CFTR) drugs elexacaftor, tezacaftor and ivacaftor (ETI) used to treat patients with cystic fibrosis (CF) who have specific gene mutations. This drug is one of the most clinically relevant for CF patients ages 2 and older and is highly prescribed in the U.S.

While ETI was fairly well-tolerated in clinical trials, some adverse effects from the medication still occur.

In collaboration with the world-renowned cystic fibrosis specialists at National Jewish Health, Advanced Diagnostic Laboratories has developed the first and only assay to measure serum levels of ETI, as well as the three primary active metabolites of the drugs.

 

About the New TRIKAFTA Drug Monitoring AssayTest Tubes

This new lab-developed test is designed to make ETI levels available clinically, allowing physicians to accurately record drug levels over time.

Draws from multiple time points after administration can be evaluated to provide a more complete picture of dose effects, allowing for more personalized medicine. The ability to accurately monitor blood ETI levels also makes it possible to assess drug-drug interaction risks and gender differences in dosing. New clinical data has indicated that the level of variability in blood ETI levels is pronounced in different groups of patients, making it valuable for clinicians to use data from this test to inform treatment plans.

This high performance liquid chromatography (HPLC) assay was fully validated using clinical data from patients taking TRIKAFTA to ensure accurate and real-world dose-response curves.

View Test Details

View NACFC Validation Poster


Our Expertise

As part of the nation’s leading respiratory hospital, National Jewish Health Advanced Diagnostic Laboratories has experience developing tests that help physicians accurately diagnose and manage respiratory diseases including CF.

Our CF Program

How to Order

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Questions? Call 303.398.1669 or email clinreflabs@njhealth.org to speak with a client services representative.