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mClear MRD Test

HapOnco® mClear MRD Test


Product Overview

HapOnco® mClear MRD Test is a non-invasive personalized ctDNA-based NGS assay with a combined tumor-informed and tumor-naïve approach for assessing MRD in solid tumor patients. Leveraging our ultra-deep sequencing platform and our proprietary MRD algorithm, VarSignal™, we can effectively filter out noisy loci based on our in-house sequencing noise database and able to detect ultra-low-frequency MRD. HapOnco® mClear MRD Test provides a comprehensive genomic landscape of a patient's tumor, enabling dynamic monitoring of cancer progression and recurrence. This equips clinicians with a more comprehensive and reliable foundation for making clinical treatment decisions.


Testing Content

The tumor-informed panel within the HapOnco® mClear MRD Test is tailored to each patient's tumor by accurately selecting 40 loci as patient-specific 'molecular labels' based on the analysis of the HapOnco® WESPlus® NGS Assay. In addition, its tumor-naïve panel comprises a predefined set of hotspot mutations and treatment-resistant mutations. This differentiated dual gene panel design not only helps improve the detection of residual tumors but also leverages the tumor-naïve design to account for evolving or treatment-resistant tumors, thereby enabling comprehensive MRD detection.

By employing customized probes, the test conducts up to 100,000X ultra-deep sequencing, allowing dynamic monitoring on patient blood samples. HapOnco® mClear MRD Test achieves a ctDNA LoD as low as 0.005%, providing patients with warnings of tumor recurrence earlier than radiological indications. This capability serves as a foundation for clinical treatment decisions and helps determine the optimal timing for treatment.

Product Advantages

(1) Compared with other major approaches for MRD assessment, NGS based on ctDNA represents a non-invasive, dynamic and more sensitive approach to track cancer progression during cancer treatment and assess if treatment needs to be adjusted, as well as longitudinally monitoring for cancer recurrence after a patient achieves remission.
(2) HapOnco® mClear MRD Test achieves up to 100,000X ultra-deep sequencing with a ctDNA LoD as low as 0.005%, well below the expert consensus for ultra-low frequency MRD.
(3) Backed by a robust experimental and bioinformatics team, HapOnco®mClear MRD Test integrates multiple technologies throughout every step of the process to minimize background noise, ensuring reliable data results.


Applicable Population

Patients with early to mid-stage operable solid tumors requiring long-term monitoring of progression.