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Highly sensitive analyses are prone to false-positive results. Duplex sequencing provides reliable sequencing of false positives and true positives.

Liquid Biopsy - Non-Small Cell Lung Cancer, Colorectal Cancer, and Melanoma

Liquid Biopsy is a non-invasive approach to assessing an individual's genetic tumor profile and tracking tumor burden in blood plasma. It facilitates pre-treatment therapy decisions and helps detect resistance and residual disease during treatment - accurately, gently, and at any time.

The detection of very low levels of tumor DNA in blood plasma is already relevant for therapy. Therefore, we offer you the necessary test procedures, including a clinical report.

Which Liquid Biopsy analyses are useful?
> EGFR p.T790M
> EGFR p.L858R
> EGFR exon 19 deletions*
> KRAS p.G12/p.G13
> BRAF p.V600E
for the detection of therapy-relevant tumor variants in metastatic NSCLC and colorectal carcinoma.1,2 In melanoma, this applies to BRAF p.V600E.

* The 15 most common deletions in one assay.

Comprehensive validation enables precise clinical interpretation.
For the detection of the lowest levels of tumor variants in blood plasma3,4,5 the determination of the following assay parameters6,7 is relevant (see table):

> Limit of Blank (LOB)

From this point on, detecting tumor variants in blood plasma is possible (95% specificity). The LOB serves as a cutoff for negative/positive concerning a tumor variant and is used to predict residual disease and therapy resistance.

> Limit of Detection (LOD)

From this point on, detecting a tumor variant in blood plasma is specific (95% sensitivity).

> Limit of Quantification (LOQ)

From this point on, a tumor variant can be quantified in blood plasma (measurement error ≤ 50 %), and monitoring of tumor progression and therapy response is possible.


Point in time

Medical topic

Relevante test parameter



Before treatment

Therapy decision



During and after treatment

Residual Disease



Residual Disease



Tumor progression



Therapy response



Table of medical topics and test parameters for Liquid Biopsy

With our Liquid Biopsy analyses, residual disease and therapy resistance can be detected very early (from 0.00-0.11% tumor variant in blood plasma). Monitoring of tumor progression or therapy response can also be highly sensitive, as the exact tumor burden can be quantified early (from 0.41-0.7 % tumor variant in blood plasma).

In a clinical study, the statement of residual disease was 90% consistent with the occurrence of metastases (n=19). The level of measured VAFs reflected tumor progression or therapy response in all cases (n=7).

The digital PCR method offers many advantages compared to NGS panels

> More sensitive due to lower LOD8,9 (see figure).
> All liquid biopsy analyses are individually validated, with no averaging.
> Indication of clinically relevant parameters LOB and LOQ8,9 in the findings.
> More cost-effective due to targeted analyses of the individual tumor variant instead of multi-hotspot panels.

1 Planchard D et al. Ann Oncol 2016;27(5):v1–v27

2 van Cutsem E et al. Ann Oncol 2016;27(8):1386–1422. doi: 10.1093/annonc/mdw235

3 Diehl F et al. Nat Med. 2008;14(9):985-90. doi: 10.1038/nm.1789

4 Remon J et al. Ann Oncol. 2017;28(4):784-790. doi: 10.1093/annonc/mdx017

5 Schwartzenberg LS et al. NPJ Precis Oncol. 2020;4:15. doi: 10.1038/s41698-020-0118

6 CLSI EP17-A Protocol for determination of limits of detection and limits of quantification; Approved Guideline.

7 Godsey JH et al. Clin. Chem.  2020;66(9):1156–1166. doi: 10.1093/clinchem/hvaa164

8 Verhein K et al. Analytical validation of Illumina's TruSight Oncology 500 ctDNA assay. 10.1158/1538-7445.AM2020-3114

9 Verma S et al. BMC Cancer. 2020;20(1):945. doi: 10.1186/s12885-020-07445-5