Haystack MRD™ Baseline
Test code
CPT code(s)*
Clinical significance
Test resources
Test FAQ
Test summary
Details
Methodology
Next Generation Sequencing
Assay category
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.
Alternative name(s)
MRD Clearance,Minimal Residual Disease,Mutation Tracking,Precision Oncology,Relapse Prediction,Tumor Burden Profiling,Tumor-Specific Mutations,NGS,Cancer Therapy,Cancer Discovery,Cancer Genomics,Circulating DNA,Circulating Tumor DNA Cells,Disease Recurrence Monitoring,Measurable Residual Disease,Molecular Genetic Testing,Molecular Residual Disease,Personalized Monitoring,Prognosis,Serial Monitoring,Solid Tumor,Therapeutic Targets,Treatment Response Assessment,Tumor-Guided MRD Testing,Tumor-Informed Disease Surveillance,Tumor-Informed Monitoring,ctDNA,CFDNA,Next Generation Sequencing,Liquid Biopsy,CT-DNA,CTCS,Cell Free DNA
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 25 mm2, ≥20% tumor content of tumor tissue in an IHC specimen transport kit and 5 mL whole blood collected in an EDTA (lavender-top) tube and 30 mL whole blood collected in 3 Streck cell-free (black/tan tiger-top or tan top) glass tubes |
| Alternative specimen(s) | 10 unstained slides at 5 microns each, plus 1 H&E slide (slide holder) |
| Minimum volume | Paraffin embedded tissue block: 25 mm2, ≥20% tumor content • Slides: 10 unstained at 5 microns each, plus 1 H&E slide • Whole blood: 3 mL EDTA (lavender-top) and 24 mL Streck (black/tan tiger-top or tan top) tubes |
| Collection instructions | This test requires three Streck tubes and 1 EDTA blood tube and a tumor specimen. Blood will be collected via Haystack MRD™ kit. Specimens may be shipped separately and at different times. Do not hold blood specimen due to short stability. Do not reject. A pathology report must accompany paraffin block or slides. Information required in this report includes: Physician identification, specimen identifiers (case and block number, specimen site and type, collection date, collection time, tissue processing used (routine or microwave), cold ischemic time, type of fixative, duration of fixative, pathologic diagnosis, and IHC score, if performed elsewhere. Please note: If Hospital Discharge Date is not populated, outpatient treatment is assumed. If unknown, please enter "NG". Please note: This test can be ordered prior to the patients planned surgery. Please enter the planned Tissue collection date, and planned Specimen Location. For all other fields related to tissue procurement please enter "NG". Blood collection using a straight needle is preferred. Use kit only. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw. If a test kit is not available in office and providers would like to utilize Quest patient service centers (PSC) for blood collection, a mail to home Haystack MRD kit should be ordered. Simply add test code 13677, "Ship to Home Collection kit, Haystack MRD™", to any other order containing Haystack MRD testing. If a test kit is not available in office and providers would like to utilize mobile phlebotomy for blood collection, a mail to home Haystack MRD kit should be ordered. Simply add test code 13676, "Mobile Phlebotomy Collection Kit, Haystack MRD™", to any order containing Haystack MRD testing. Please note: If Mobile Phlebotomy is involved, a collection kit will be shipped to the patient. Mobile phlebotomy is only involved in the collection of the blood specimen. Tissue collection is not mobile eligible. We will automatically mail this kit to your patient's home. Patients will also be reminded if they forget to schedule their appointment. Patients should be advised not to remove contents prior to their PSC visit. Note: If there are multiple blocks for the primary tumor, please send the block with the highest tumor content. |
| Transport container | Paraffin embedded tissue block: Formalin-fixed, paraffin-embedded tissue block (IHC specimen transport kit) Blood: EDTA (lavender-top) tube and 3 Cell-free DNA Streck (black/tan tiger-top or tan top) tubes |
| Transport temperature | FFPE: Room temperature or on ice pack in summer Slides: Room temperature Whole blood: Room temperature in kit |
| Specimen stability | Paraffin-embedded tissue block and slides Whole blood in kit |
| Reject criteria | Hemolysis |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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