Respondr® TNF

Test Code
18555


CPT Codes
81599<br>Restricted Client Code

Preferred Specimen
3 mL whole blood collected in an EDTA (lavender-top) tube


Patient Preparation
IBD patients ≥35 kg

Respondr TNF is a precision-medicine test that requires patient weight, in kg, at the time of sample collection for testing to occur. Failure to provide the required information at the time of ordering, will result in reporting delays or cancellation.

Minimum Volume
3 mL


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 10 days
Refrigerated: 30 days
Frozen: Unacceptable


Methodology
Genotyping • Quantitative Polymerase Chain Reaction • SNP Targeted Sequencing

Setup Schedule
Set up: Varies; Report available: 5 business days from data of receipt


Reference Range
Pre-Therapy Clearance<0.326 L/day
HLA DQA1*05See Laboratory Report
Albumin3.7-5.1 g/dL


Clinical Significance
Respondr® TNF is a test that indicates the likelihood of response to infliximab, adalimumab, or their biosimilars, prior to initiation of therapy. The test provides objective evidence to help guide therapeutic selection by stratifying patients based on how their unique pharmacokinetic and genetic profile influences their ability to acheive and sustain a therapeutic response to anti-TNF therapy. The test also indentifies those who may benefit from more active therapeutic management.

Pre-therapy drug clearance, a pharmacokinetic patient characteristic, is derived via a populaton pharamcokinetic model-based formula that combines patient-specific variables and laboratory results. HLA-DQA1*05 risk variant status is determined by a single nucleotide polymorphism (SNP) rs2097432 quantitative PCR genotyping assay.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.