Cell-Free DNA KRAS 12, 13, 61, 146, Blood
Use
The test serves as an alternative to invasive tissue biopsies for determining the mutation status of KRAS at codons 12, 13, 61, and 146. It detects molecular markers associated with response or resistance to specific therapies, particularly in colorectal cancer patients. The test evaluates cell-free DNA (cfDNA) for KRAS mutations, providing information useful for guiding treatment decisions and assessing patient eligibility for targeted therapies.
Special Instructions
Samples should be transported at ambient temperature or refrigerated at 4 degrees Celsius. Samples remain viable for 7 days when collected in the Streck Black/Tan Top Tube Kit (T715).
Limitations
This test is not intended for use as a cancer screening tool. It is not clinically validated to monitor therapy response or for early tumor detection. Negative results do not rule out the presence of KRAS mutations as the assay's limit of detection is influenced by the amount of cfDNA, a variable factor. Additionally, the test cannot differentiate between somatic and germline alterations, necessitating further testing for hereditary risk evaluation.
New York Approved
Methodology
PCR-based (Digital Droplet Polymerase Chain Reaction)
Biomarkers
LOINC Codes
- In Process
- 50397-9
- 69047-9
- 48767-8
- 31208-2
- 18771-6
- 75974-6
Result Turnaround Time
5-10 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
Two 10-mL Streck Cell-Free DNA blood collection tubes
Minimum Volume
One 10 mL Streck tube
Container
Streck Cell-Free DNA blood collection kit
Collection Instructions
Blood should be collected in Streck Cell-Free DNA BCT tubes and will be processed to produce platelet-poor plasma before cfDNA isolation. Samples should be transported at ambient temperature or refrigerated at 4 degrees Celsius.
Causes for Rejection
Specimen collected in tube other than Streck Cell-Free DNA collection tube
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 7 days |