Methodology
Molecular
Test Description and clinical significance
Disease:
Solid tumors; Breast cancer, Ovarian cancer, Prostate cancer and Pancreatic cancer
Concurrent ctDNA (523 genes mutations and fusions) including TMB and MSI and Germline Reporting from Liquid Biopsy for PARPi treatment for breast, ovarian, pancreatic and prostate cancers.
Specimen Requirements
Collection:
Two-Three tubes of peripheral blood (10mL/tube) are collected in PAXgene Blood ccfDNA, For best results, a 21G or 22G needle is advised. Previously extracted cfDNA is acceptable. A minimum of 50 µL of each cfDNA with a
concentration of at least 0.60 ng/µ, corresponding to total at least 30ng of cfDNA,
fragment size between 100-200 bp, obtained on a TapeStation Cell-free DNA ScreenTape
or related instruments for assessment of cfDNA quality.
Stability:
48 hours
Unacceptable Conditions:
Do not freeze.
Specimen submitted is not in the PAXgene Blood ccfDNA tube or in the PAXgene Blood
ccfDNA tube after expired date.
Storage & Transport
Store tubes within the recommended temperature range
(18°C to 25°C) within 2 days, including shipping.
CPT(s)
"81462 and G0452(26) *Additional CPT codes may be applied"
New York Approved
No
TAT
7-10 days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
With core values rooted in service and integrity, our leadership team sets the bar high.
We consistently strive to set the model for exactly how a reference laboratory should engage with both physicians and patients.
siParadigm is accredited by CLIA (Clinical Laboratory Improvement Amendments) and certified by CAP (College of American Pathologists).
We also hold select state licensure where required.