Liquid Biopsy Test | Fulgent Oncology

TEST DESCRIPTION

The Lumera™ Liquid Biopsy ctDNA test is a qualitative analysis that uses next-generation sequencing to analyze solid tumors via a simple blood draw. This analysis detects single nucleotide variants (SNVs) and insertions and deletions (indels, up to 40bp) in 523 genes, as well as assess tumor mutational burden (TMB) and microsatellite instability (MSI).

Method: NGS
Sensitivity: ≥ 99%
Specificty: 99.99%
Mean Coverage: >1000x
Turnaround Time: 10 business days from receipt of specimen in the laboratory

SPECIMEN REQUIREMENTS

Peripheral Whole Blood Collected in PAXgene ctDNA tubes or Streck ctDNA tubes

Volume: 2 x 10mL tubes (when possible)

SHIPPING

Store specimens at 2°C - 8°C until ready to ship.
Sample receipt within 72 hours of collection is strongly recommended.
Samples can be shipped at ambient or refrigerated temperatures, using cold packs as needed (do not freeze).

A diagram depicting an inside of the bloodstream. There are makers indicating red blood cells, Exosome with tumor DNA, Circulating Tumor DNA, Circulating Tumor Cell, Tumor, and Normal circulating DNA.

A Non-Invasive Solution for Precision Oncology Treatment

In cases where obtaining a tissue biopsy is difficult, comprehensive tumor profiling via liquid biopsy is a valuable tool for diagnosing and monitoring cancer. Standard tissue sampling is an invasive procedure which is not always available and does not always yield sufficient sample for testing. Circulating tumor DNA (ctDNA) analysis only requires a simple blood draw and provides results that can be used to help develop treatment and management plans in alignment with precise biomarker results.

This test is an option for patients with hard-to-biopsy tumors, tumors resected at a previous point in time, or metastasized tumors.
This test has Medicare coverage (MolDx approved).

Reference: PMID: 37865292