Test Details
Methodology
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 and next-generation sequencing libraries are prepared for the tumor, germline and 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 Colon 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.
If whole blood collected in a cell-free DNA BCT (Streck tube) and a formalin-fixed, paraffin-embedded tissue (FFPE) block or slides from tissue resection are not received together, forward the Streck tube to the testing laboratory by themselves. Do not hold the Streck tubes. A copy of the original pathology report, the date of the surgical resection and the test specific test requisition form are required for testing. If these are not received with the sample, testing will be delayed. Please direct any questions regarding this test to customer service at 800-345-4363. The testing location will begin the block procurement process; however, testing will be delayed. If the formalin-fixed resection is not received within 14 days, testing will be canceled.
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) and formalin-fixed, paraffin-embedded tissue (FFPE) block or slides from tissue resection
Volume
20 mL whole blood collected in two cell-free DNA BCT (Streck tubes) and 9 pre-cut unstained slides from paraffin block cut at 5 micron thickness and 1 matching H&E reference slide or FFPE tissue block
Minimum Volume
10 mL whole blood collected in a cell-free DNA BCT (Streck tube); tumor surface area ≥ 4mm2 tumor area; tumor content ≥20% is preferred
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.
FFPE: Maintain blocks/slides at room temperature.
Causes for Rejection
Whole blood: Any tube type that is not cell-free DNA BCT (Streck tube)
FFPE: Specimen does not meet all of the above criteria for sample type, container, minimum volume, collection and storage; no tumor tissue in FFPE block or slides; broken or stained slides; fixative other than formalin
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 |
|---|---|---|---|---|---|---|
| 484442 | PlasmaDetectGenome MRD-Base | REQUEST | 484475 | Tumor Status | Pending | |
| 484442 | PlasmaDetectGenome MRD-Base | REQUEST | 484476 | Plasma Stabilization | 8251-1 | |
| Order Code | 484442 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Base | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484475 | |||||
| Result Code Name | Tumor Status | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 484442 | |||||
| Order Code Name | PlasmaDetectGenome MRD-Base | |||||
| Order Loinc | REQUEST | |||||
| Result Code | 484476 | |||||
| Result Code Name | Plasma Stabilization | |||||
| UofM | ||||||
| Result LOINC | 8251-1 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484443 | ctDNA status | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484443 | |||||
| Result Name | ctDNA status | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484445 | %ctDNA | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484445 | |||||
| Result Name | %ctDNA | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484446 | Indication | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484446 | |||||
| Result Name | Indication | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484447 | Location | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484447 | |||||
| Result Name | Location | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484591 | Specimen Type | 66746-9 | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484591 | |||||
| Result Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | 66746-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484449 | Specimen Type | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484449 | |||||
| Result Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484452 | Block ID | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484452 | |||||
| Result Name | Block ID | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484453 | Background | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484453 | |||||
| Result Name | Background | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484454 | Method | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484454 | |||||
| Result Name | Method | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484455 | References | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484455 | |||||
| Result Name | References | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 484456 | Director Review | Pending | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 484456 | |||||
| Result Name | Director Review | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 000000 | Serial Monitoring | N/A | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 000000 | |||||
| Result Name | Serial Monitoring | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 480903 | Microdissection Performed | 8100-0 | |
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 480903 | |||||
| Result Name | Microdissection Performed | |||||
| UofM | ||||||
| Result LOINC | 8100-0 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 484478 | Plasma Detect - Landmark | 511958 | 80563-0 | ||
| Reflex 1 | ||||||
| Order Code | 484478 | |||||
| Order Name | Plasma Detect - Landmark | |||||
| Result Code | 511958 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 | |||||