Why is this important?
Emerging data from a range of tumor studies demonstrate a correlation between tumor volume and estimated ctDNA fraction and in many cases, ctDNA may be present at close to, or less than, 1 tumor genomic equivalent per 10 mL blood tube for small or low DNA-shedding tumors.
In addition, against a high background of total cell-free DNA (cfDNA), the ctDNA released in the bloodstream prior to treatment is often ≤0.01% among early-stage cancer patients. Therefore, highly sensitive assays such as RaDaR, with a LoD95 of 0.001% variant allele fraction (VAF), are required for the detection of very low, but clinically relevant, ctDNA levels after treatment.
Why choosing a high-performance test matters
1
Detect more patients with residual disease
High sensitivity enables detection of more patients with residual disease and better stratification of those at high risk of relapse.
High sensitivity MRD tests are required to detect microscopic levels of ctDNA. RaDaR detects ctDNA down to 0.001% VAF.
Not all MRD tests are the same
Not all MRD tests are the same. In a hypothetical situation, a patient was diagnosed with Stage II CRC. Four weeks after surgery, an MRD test was performed and ctDNA was not detected. The limit of detection of this test was 0.01% VAF.
Before surgery, the patient’s ctDNA level was above the limit of detection for imaging, so their tumor burden was readily identifiable. Four weeks following resection, the ctDNA level had dropped below the limit of detection for this MRD test, so when the test was performed, ctDNA was not detected.
But what if the same patient was tested with the RaDaR MRD test instead? RaDaR’s limit of detection is 0.001% VAF. This time the result is different. Four weeks following resection, the ctDNA level had dropped, but because RaDaR can detect very low levels of ctDNA, this time, ctDNA was detected.
| RaDaR’S HIGH SENSITIVITY OF 0.001% VAF DETECTS ctDNA IN SAMPLES THAT LESS-SENSITIVE TECHNOLOGIES MAY MISS1-3 | |||
|---|---|---|---|
Breast cancer |
Non-small cell lung cancer |
Head & neck cancers |
|
| ctDNA detection <0.01% VAF1-3 | 25% of study samples with detectable ctDNA | 36% of study samples with detectable ctDNA | 31% of study samples with detectable ctDNA |
2
Detect cancer recurrence sooner
High sensitivity enables longer lead times ahead of standard-of-care monitoring tools, such as radiographic imaging. RaDaR’s high sensitivity allows for earlier identification of residual disease and opens up the possibility of intervention prior to overt metastatic disease.
Not all MRD tests are the same. In a hypothetical situation, a patient was diagnosed with Stage II CRC. Four weeks after surgery, an MRD test was performed and ctDNA was not detected. The limit of detection of this test was 0.01% VAF.
Before surgery, the patient’s ctDNA level was above the limit of detection for imaging, so their tumor burden was readily identifiable. Four weeks following resection, the ctDNA level had dropped below the limit of detection for this MRD test, so when the test was performed, ctDNA was not detected.
But what if the same patient was tested with the RaDaR MRD test instead? RaDaR’s limit of detection is 0.001% VAF. This time the result is different. Four weeks following resection, the ctDNA level had dropped, but because RaDaR can detect very low levels of ctDNA, this time, ctDNA was detected.
MEDIAN LEAD TIMES FOR RELAPSE OR RECURRENCE2-5
In studies of different cancer types, RaDaR’s high sensitivity allowed for improved lead times in identifying relapse or recurrence. Median lead times were as follows: in various subtypes of early-stage breast cancer, 12.9 months; in high-risk early HR+ breast cancer, 12.4 months; in Stage IA–IIIB NSCLC, 6.6 months; in Stage I–IV HNSCC, 5.1 months.
3
High confidence in results
High specificity means confidence that a positive result is truly positive.
- Often tests sacrifice specificity to achieve high sensitivity; RaDaR has been designed to balance these two features
- RaDaR’s unique approach to MRD testing allows for exceptional specificity. The RaDaR workflow:
- Filters out clonal hematopoiesis of indeterminate potential (CHIP) and germline mutations in the custom assay
- Uses an aggregated, algorithmic approach for MRD result determination to reduce false positive results with every test
- Includes a built-in quality control (QC) process to reduce errors
CI = confidence interval; HR = hazard ratio.
* Excluding patient with brain metastases.
References: 1. Lynce P, et al. https://neogenomics.com/sites/default/files/literature/Peripheral_immune_subsets_and_ctDNA_in_patients_with_residual_TNBC_SABCS_2021.pdf. Accessed February 22, 2023. 2. Gale D, et al. Ann Oncol. 2022;33(5):500-510. 3. Flach S, et al. https://neogenomics.com/sites/default/files/literature/LBx_for_detection_of_molecular_residual_disease_ESMO_2022.pdf. Accessed February 24, 2023. 4. Lipsyc-Sharf M, et al. J Clin Oncol. 2022;40:2408-2419. 5. Cutts R, et al. AACR 2021 Abstract 536. 6. Elliot MJ, et al. San Antonio Breast Cancer Symposium, 2022. Abstract P6-01-16. 7. Coakley M, et al. https://neogenomics.com/sites/default/files/literature/1309878%20PD5-03%20Coakley%20et%20al.%20Comparison_MRD_assay.pdf. Accessed February 22, 2023.
RaDaR MRD testing is validated for the use in multiple solid tumor cancers
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