Test Details
Methodology
Whole genome sequencing data of plasma obtained from peripheral whole blood specimens of monitoring specimens is compared with baseline sequencing data from tumor-informed whole genome sequencing utilizing matched FFPE tumor tissue, white blood cells and plasma obtained from peripheral whole blood.
Nucleic acid extraction is performed on plasma from peripheral whole blood from the monitoring specimen and next-generation sequencing libraries are prepared for cell-free DNA, which are then sequenced. Data analysis is performed for alignment, quality control analyses, single nucleotide variant calling and filtering to provide the overall status for detectable ctDNA along with an estimate of tumor content. The analytical sensitivity of the Labcorp Plasma Detect Genome MRD tests is 0.005% tumor content with 99.4% analytical specificity.
Use
The Labcorp Plasma Detect Genome MRD tests are intended for the detection of circulating tumor DNA (ctDNA) in stage III colon cancer patients after surgery or adjuvant chemotherapy to identify individuals who may have an increased risk of recurrence. Emerging evidence supports the clinical utility of detection of ctDNA in the diagnosis of disease progression, recurrence and/or relapse in advanced colorectal cancer. Patients with detectable ctDNA after surgery or adjuvant chemotherapy are at an increased risk of recurrence compared to patients without detectable ctDNA. ctDNA level (%) represents the proportion of the cell-free DNA sample that exhibits evidence of tumor-specific single nucleotide variants.
Special Instructions
This test currently is not approved for use in New York state.
Limitations
The analytical sensitivity of the Labcorp Plasma Detect Genome MRD tests may be limited by insufficient coverage in specific regions of the genome, inability to distinguish highly related human sequences and sequencing or other technical errors. The analysis of genetic alterations can also be hampered by multiple aspects related to the sample and DNA. Low quantity of DNA obtained can limit the amount of DNA molecules that can be successfully analyzed by next generation sequencing.
The variant allele frequency and number of tumor-specific molecules depends on various factors including sample collection timing (post-surgery or while on therapy), pre-analytical sample processing and clinical characteristics unrelated to tumor status. The concentration of tumor-derived DNA can be a factor, as a portion of the DNA analyzed may be derived from contaminating normal cells.
A negative result does not definitely indicate the absence of cancer. ctDNA dynamics may also reflect overall tumor burden response as a result of clinical intervention or during surveillance through longitudinal assessments.
The Labcorp Plasma Detect Genome MRD tests are designed to detect ctDNA derived from the assayed tumor only and has not been validated to detect new primary tumors.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Whole blood collected in a cell-free DNA BCT (Streck tube)
Volume
20 mL whole blood collected in two cell-free DNA BCT (Streck tubes)
Minimum Volume
10 mL whole blood collected in a cell-free DNA BCT (Streck tube)
Collection Instructions
Whole blood: Samples collected in cell-free DNA BCT are stable for up to seven days at temperatures between 2°C and 30°C. Indicate date and time of collection on test request form.
Causes for Rejection
Whole blood: Any tube type that is not cell-free DNA BCT (Streck tube)
References
Alarcon CR, et al. Circulating tumour DNA ctDNA) in patients with stage III colon cancer: the multicentre prospective PROVENC3 study. British Journal of Surgery, in press.
Alarcon, CR, Georgiadis A, Franken IA, et al. Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: The PROVENC3 study. Cancer Res. 2024 Mar 15;84(6)Suppl:6559-6559.
Burbach JPM, Kurk SA, Coebergh van den Braak RRJ, et al. Prospective Dutch colorectal Cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research. Acta Oncol. 2016 Nov;55(11):1273-1280. Epub 2016 Aug 25. PubMed 27560599
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. 2022 Feb 1;28(3):507-517. Epub 2021 Oct 8. PubMed 34625408
Kotani D, Oki E, Nakamura Y, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nat Med. 2023 Jan;29(1):127-134. Epub 2023 Jan 16. PubMed 36646802
Schraa SJ, van Rooijen KL, van der Kruijssen DEW, et al. Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study. BMC Cancer. 2020 Aug 20;20(1):790. PubMed 32819390
Tie J, Cohen JD, Lahouel K, et al. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. Epub 2022 Jun 4. PubMed 35657320
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 Dec 1;5(12):1710-1717. Erratum in: JAMA Oncol. 2019 Dec 1;5(12):1811. PubMed 31621801
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484561 | Specimen Type | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484552 | ctDNA status | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484445 | %ctDNA | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484555 | Background | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484556 | Method | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484557 | References | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 484558 | Director Review | Pending | |
| 484551 | PlasmaDetectGenome MRD-Monitor | REQUEST | 511958 | 80563-0 | ||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484561 | |||||
| Result Code Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484552 | |||||
| Result Code Name | ctDNA status | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484445 | |||||
| Result Code Name | %ctDNA | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484555 | |||||
| Result Code Name | Background | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484556 | |||||
| Result Code Name | Method | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484557 | |||||
| Result Code Name | References | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484558 | |||||
| Result Code Name | Director Review | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484551 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Monitor | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 511958 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 |