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Haystack MRDTM Testing

Test codes: 13682, 13151

Haystack MRD is a tumor-informed MRD test that reports the presence or absence of circulating tumor DNA (ctDNA) in the blood of patients with a previous or current diagnosis of a solid tumor cancer. The detection of ctDNA after curative intent treatment has been linked to an increased risk of disease recurrence; conversely, when ctDNA is not detected, the risk of recurrence may be lower.1-6

The longitudinal monitoring of ctDNA can identify cancer progression, recurrence, or relapse before clinical, biological, or radiographical evidence indicates progression, recurrence, or relapse.1,3,7-9 Serial monitoring of ctDNA dynamics has also been shown to be a predictor of therapy response.10-16

What is the difference between Haystack MRDTM Baseline and Monitoring tests?

For a first-time patient, a Haystack MRD Baseline test must be ordered to create a personalized minimal residual disease (MRD) assay that will be used for all subsequent Haystack MRD Monitoring tests.

The Haystack MRD Baseline test requires three (3) specimen types:

  • Formalin-fixed paraffin-embedded tumor tissue
  • One (1) 6-mL EDTA blood tube (collected as soon as possible)
  • Three (3) 10-mL Streck Cell-Free DNA blood tubes (must be collected >2 weeks after the tissue collection procedure)

The 2 baseline blood draws may be performed at the same time if the collection occurs >2 weeks post-tissue collection OR blood draws may be performed at different times, and shipped separately:

  • EDTA can be collected < 2 weeks post-tissue collection 
  • Streck must be collected > 2 weeks post-tissue collection 

For returning patients, Haystack MRD Monitoring tests should be ordered. Haystack MRD Monitoring tests require the following specimens:

  • Three (3) 10-mL Streck Cell-Free DNA tubes

The frequency of minimal residual disease (MRD) testing can differ depending on clinical context.

Suggested testing cadences can be found below.

Suggested testing cadences.

Please click the image to enlarge (opens in a new window).

Blood can be drawn in-clinic using a Haystack Blood Collection Kit, or a Haystack Blood Collection Kit can be shipped directly to the patient’s home and Quest Support will reach out to schedule an at-home mobile phlebotomy collection appointment.

Haystack MRD can track up to 50 tumor-informed mutations in each personalized minimal residual disease (MRD) assay.

Due to the complexity of the initial tissue testing and personalized assay design, Haystack MRD Baseline results are typically available 30 days after the receipt of both tissue and blood samples in our laboratory.

All subsequent Haystack MRD Monitoring results are typically available 7 to 10 days after the receipt of blood samples in our laboratory.

The Haystack MRD report provides the presence or absence of circulating tumor DNA (ctDNA) and the quantity of ctDNA in units of mean ctDNA molecules per mL of plasma. Results for all previously tested timepoints are provided to assess changes in ctDNA levels over time.

A “MRD Detected” result indicates the presence of residual cancer in the body. Subsequent Haystack MRD Monitoring tests can be ordered to track if the amount of circulating tumor DNA (ctDNA) increases or decreases in response to treatment over time.

A “MRD Not Detected” result reflects a lack of ctDNA detection at the time of the blood draw, which may indicate the absence of residual cancer but does not definitively exclude the possibility of residual disease in the patient. Subsequent Haystack MRD Monitoring tests can be ordered to track whether residual disease remains undetectable over time.

We are actively working with the Centers for Medicare & Medicaid Services (CMS) and private insurance companies to secure coverage for Haystack MRD. In the meantime, we have implemented a supplemental financial assistance program to limit financial hardship faced by eligible patients.

References

  1. Tie J, Wang Y, Tomasetti C, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016;8(346):346ra92-346ra92. doi:10.1126/scitranslmed.aaf6219
  2. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451. doi:10.1038/nature22364
  3. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):10.1001/jamaoncol.2019.0528. doi:10.1001/jamaoncol.2019.0528
  4. Tie J, Cohen JD, Wang Y, et al. Circulating tumor DNA analyses as markers of recurrence risk and benefit of adjuvant therapy for stage III colon cancer. JAMA Oncol. 2019;5(12):1710. doi:10.1001/jamaoncol.2019.3616
  5. Wang Y, Li L, Cohen JD, et al. Prognostic potential of circulating tumor DNA measurement in postoperative surveillance of nonmetastatic colorectal cancer. JAMA Oncol. 2019;5(8):1118. doi:10.1001/jamaoncol.2019.0512
  6. Magbanua MJM, Swigart LB, Wu HT, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021;32(2):229-239. doi:10.1016/j.annonc.2020.11.007
  7. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-4263. doi:10.1158/1078-0432.ccr-18-3663
  8. Moding EJ, Liu Y, Nabet BY, et al. Circulating tumor DNA dynamics predict benefit from consolidation immunotherapy in locally advanced non-small cell lung cancer. Nat Cancer. 2020;1(2):176-183. doi:10.1038/s43018-019-0011-0
  9. Henriksen TV, Tarazona N, Frydendahl A, et al. Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward assessment of adjuvant therapy efficacy and clinical behavior of recurrences. Clin Cancer Res. 2021;28(3):507-517. doi:10.1158/1078-0432.ccr-21-2404
  10. Tie J, Kinde I, Wang Y, et al. Circulating tumor DNA as an early marker of therapeutic response in patients with metastatic colorectal cancer. Ann Oncol. 2015;26(8):1715-1722. doi:10.1093/annonc/mdv177
  11. Etienne GL, Guillaume H, Coraline D, et al. Circulating tumor DNA evaluated by next-generation sequencing is predictive of tumor response and prolonged clinical benefit with nivolumab in advanced non-small cell lung cancer. OncoImmunology. 2018;7(5):e1424675-e1424675. doi:10.1080/2162402x.2018.1424675
  12. Goldberg SB, Narayan A, Kole AJ, et al. Early assessment of lung cancer immunotherapy response via circulating tumor DNA. Clin Cancer Res. 2018;24(8):1872-1880. doi:10.1158/1078-0432.ccr-17-1341
  13. Lee JH, Long GV, Menzies AM, et al. Association between circulating tumor DNA and pseudoprogression in patients with metastatic melanoma treated with anti–programmed cell death 1 antibodies. JAMA Oncol. 2018;4(5):717. doi:10.1001/jamaoncol.2017.5332
  14. Chen K, Zhao H, Shi Y, et al. Perioperative dynamic changes in circulating tumor DNA in patients with lung cancer (DYNAMIC). Clin Cancer Res. 2019;25(23):7058-7067. doi:10.1158/1078-0432.CCR-19-1213
  15. Váraljai R, Wistuba-Hamprecht K, Seremet T, et al. Application of circulating cell-free tumor DNA profiles for therapeutic monitoring and outcome prediction in genetically heterogeneous metastatic melanoma. JCO Precis Oncol. 2019;(3):1-10. doi:10.1200/po.18.00229
  16. Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020;1(9):873-881. doi:10.1038/s43018-020-0096-5

 

This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

 

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