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FDA-approved companion diagnostic

POMC/PCSK1/LEPR CDx Panel

NGS-based genetic panel that detects pathogenic variants in POMC, PCSK1, and LEPR to identify patients with rare monogenic obesity for targeted therapy.

Lab-developed CDxMethod: NGSSpecimen: Whole blood, SalivaBiomarker: POMC, PCSK1, LEPR
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
DEN200059
Supplements
Manufacturer
Prevention Genetics (Exact Sciences)
Approval date
January 21, 2022
Test specifications
Methodology
NGS
Specimen
Whole blood, Saliva
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
POMC, PCSK1, LEPR
What this test is

POMC/PCSK1/LEPR CDx Panel is a next-generation sequencing assay that analyzes coding regions and splice sites of POMC, PCSK1, and LEPR to detect pathogenic and likely pathogenic variants associated with rare, early-onset severe obesity. Results help identify patients whose disease may be driven by MC4R pathway defects and who may be considered for pathway-targeted treatment.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
ObesityPOMC, PCSK1 and LEPRVariants (Pathogenic/Likely Pathogenic) and Variants of Uncertain SignificanceIMCIVREE

Performing lab

Prevention Genetics (Exact Sciences)

Marshfield Lab (52D2065132)

Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics, a wholly owned subsidiary of Exact Sciences Corp., is a Clinical Laboratory Improvement Amendments (CLIA) and International Organization for Standardization (ISO) 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics provides tests for nearly all clinically relevant genes, including the powerful and comprehensive whole genome sequencing test, PGnome® and whole exome sequencing test, PGxome®.

Order this test

If your organization is connected to Casandra, you can place an electronic order forPOMC/PCSK1/LEPR CDx Panel directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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