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)
Contact us to request a kit
info@fulgentoncology.com
info@fulgentoncology.com
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 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
Evaluates 523 genes for SNVs + insertions/deletions up to 40bp
Key immuno-oncology biomarkers TMB and MSI included in analysis
High sensitivity and specificity down to 0.5% VAF with low DNA input (30ng)
Robust variant detection in genes with actionable guidelines and treatments
FOR LIQUID BIOPSY TESTING
How It Works
Collect the sample
Sample collection kits are available upon request.
Place your order
Order on the portal or download and fill out our paper requisition.
Ship the sample to Fulgent
Send specimen and completed requisition to Fulgent Oncology.
Receive your report
All reports will be available for download in your portal within 10 business days of receipt of sample.
Additional Resources
Contact Us
We'd love to work with you. Please fill out this form and our team will be in touch.