120,000
cancer patients annually have actionable fusions [1], [2]*.
*Derived from 6.0% of samples druggable fusions detected in a 9,624 sample cohort, extrapolated to 2 million new US cancer cases per year.
In a study of 1007 plasma samples from over 30 cancer types across the USA and Asia,
ctDNA alone detected only 65% of gene fusions [3].
Tissue biopsy for cancer diagnosis can be hard to access.
1 in 3
NSCLC cases have insufficient tissue yield to perform comprehensive genomic profiling [4].
LiquidHALLMARK is an ultrasensitive blood test designed to detect tumor-derived ctDNA and ctRNA to identify cancer-related mutations and biomarkers with a single blood draw.
LiquidHALLMARK is currently Medicare covered under CPT code 0571U for qualifying patients with advanced cancer. Download our Insurance and Billing Instructions to find out more.
Lucence is collaborating with Mayo Clinic Laboratories to expand access to LiquidHALLMARK testing.
LiquidHALLMARK has been added to Mayo Clinic Laboratories test catalog.
What is ctDNA and ctRNA?
ctDNA is shed by dying cancer cells while ctRNA is actively released by living cancer cells [5]. Combining ctDNA + ctRNA analysis has shown to increase the detection of actionable fusions by 36.7% (11/30) [3].
LIQUIK Prospective Study Demonstrates Utility of Combined ctDNA and ctRNA [6].
Study results showed that
LiquidHALLMARK ctDNA + ctRNA detected 15.6% (52 vs 45) more tissue-confirmed, NCCN guideline-recommended biomarkers* than a FDA-approved ctDNA only test, with 93-100% agreement with tissue NGS.
LiquidHALLMARK ctDNA demonstrated non-inferiority compared to the FDA-approved ctDNA only test, detecting 72.1% (vs 66.1%) of patients with tissue-confirmed NCCN guideline-recommended biomarkers*.
LiquidHALLMARK detected actionable biomarkers in
-
41.9% (13/31) patients with failed tissue biopsy
-
13.0% (6/46) patients deemed tissue NGS negative
Specifications [6] - [9]
Single Nucleotide Variants (SNVs)
>91%
Sensitivity
>99%
Specificity
0.1% VAF
LOD
Insertions / Deletions (indels)
>90%
Sensitivity
>99%
Specificity
0.1% VAF
LOD
ctDNA fusions
>96%
Sensitivity
>95%
Specificity
0.1% VAF
LOD
ctRNA fusions
>91%
Sensitivity
>99%
Specificity
10 copies
LOD
References:
-
Gao, Q. et al. Cell Reports 2018; 23(1): 227-238.E3.
-
National Cancer Institute. Cancer Statistics. Accessed August 15 2025. https://www.cancer.gov/about-cancer/understanding/statistics
-
Chan, D. Paper presented at: ASCO Annual Meeting; June 2, 2025; Chicago, IL.
-
Sehayek et al. IASCLC Liquid Biopsy Oct 2020.
-
Stejskal P, et al. Mol Cancer 2023; 22(15).
-
Poh J. et al. 2022. PLoS ONE 17(4): e0267389.
-
Choudhury, Y. et al. Ann. Oncol., 29, 2018 (suppl_9; mdy441.010).
-
Choudhury, Y. et al. J Clin Oncol 36: 2018 (suppl; abstr e24107).
-
Choudhury, Y. et al. AACR; Clin Cancer Res 2020; 26(11_Suppl): Abstract nrA41.
-
Samol J, et al. JCO Precis. Oncol. 2025; 9: e2500181.
