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Haystack MRD™ Monitoring
Test Code13151
CPT Codes
⁠⁠⁠⁠⁠⁠⁠0561U<br><strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
30 mL whole blood collected in 3 Streck cell-free (black/tan tiger-top) glass tubes
Minimum Volume
24 mL
Instructions
Sample collection using a straight needle is preferred. Use Streck tubes only. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw.
Please note: If Hospital Discharge Date is not populated, outpatient treatment is assumed.
Please note: If Hospital Discharge Date is not populated, outpatient treatment is assumed.
Transport Container
Cell-free DNA Streck tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 7-14 days
Reference Range
See Laboratory Report
Clinical Significance
Haystack MRD™ is a tumor-informed minimal residual disease (MRD) test that analyzes circulating tumor DNA (ctDNA) in the blood of patients who have been diagnosed with cancer or a previous diagnosis of cancer. The test requires identification of tumor-specific mutations for the development of a personalized ctDNA assay (Haystack MRD™ Personalization). The personalized assay is used to measure ctDNA to identify the presence of cancer in an initial blood sample (Haystack MRD™ Baseline) and at subsequent timepoints (Haystack MRD™ Monitoring).
Circulating tumor DNA (ctDNA) in blood is measured at specified intervals, after baseline, using the tumor- specific, personalized assay developed in the previous Haystack MRD™ Personalization step. Detection of ctDNA at one or multiple timepoint(s) may inform a patient's response to therapy and/or indicate cancer recurrence.
Circulating tumor DNA (ctDNA) in blood is measured at specified intervals, after baseline, using the tumor- specific, personalized assay developed in the previous Haystack MRD™ Personalization step. Detection of ctDNA at one or multiple timepoint(s) may inform a patient's response to therapy and/or indicate cancer recurrence.
