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Haystack MRD™ Baseline
Test Code13682
CPT Codes
81479<br><strong>This test is not available for New York patient testing</strong>
Preferred Specimen
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
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
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
Other Acceptable Specimens
10 unstained slides at 5 microns each, plus 1 H&E slide (slide holder)
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.
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
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
Slides: Room temperature
Whole blood: Room temperature in kit
Specimen Stability
Paraffin-embedded tissue block and slides
Room temperature: Acceptable
Refrigerated: Preferred
Frozen: Unacceptable
Whole blood in kit
Room temperature: 7 days
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 Med fusion. 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: 4-8 weeks after receipt of tumor and blood samples
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 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™ Baseline). The personalized assay is used to measure ctDNA to identify the presence of cancer in an initial blood sample and at subsequent timepoints (Haystack MRD™ Monitoring).
The Haystack MRD(TM) test process begins with sequencing of tumor tissue and a matched normal sample to develop a tumor- specific, personalized assay that is used for the Haystack MRD™ Baseline and Haystack MRD™ Monitoring circulating tumor DNA (ctDNA) tests.
Circulating tumor DNA in blood is measured using the tumor- specific, personalized assay developed in the Haystack MRD™ Baseline step. Detection of ctDNA indicates the presence of minimal residual disease (MRD) which may inform recurrence risk. This baseline result is followed by Haystack MRD™ Monitoring tests to monitor treatment response and cancer recurrence.
The Haystack MRD(TM) test process begins with sequencing of tumor tissue and a matched normal sample to develop a tumor- specific, personalized assay that is used for the Haystack MRD™ Baseline and Haystack MRD™ Monitoring circulating tumor DNA (ctDNA) tests.
Circulating tumor DNA in blood is measured using the tumor- specific, personalized assay developed in the Haystack MRD™ Baseline step. Detection of ctDNA indicates the presence of minimal residual disease (MRD) which may inform recurrence risk. This baseline result is followed by Haystack MRD™ Monitoring tests to monitor treatment response and cancer recurrence.
