Pan-cancer

Cancer Type

Formalin-fixed, paraffin-embedded (FFPE) tumor tissue

Specimen Requirements

14 calendar days

Turnaround Time ¹

OncoOmicsDx™ Clinical Tumor Proteomics Test utilizes an advanced high-throughput mass spectrometry platform combined with proprietary targeted proteomics technology to perform absolute quantification of key tumor-associated proteins. Each test can simultaneously measure the expression levels of up to 30 or 72 tumor biomarker proteins, delivering high-resolution protein expression data for patients with solid tumors. The results from OncoOmicsDx™ offer comprehensive insights into tumor biology at the protein expression level, empowering healthcare professionals to develop more personalized and precise treatment strategies—ultimately improving therapeutic outcomes and the quality of patient care.

Proteomics in action – The next horizon in precision oncology for cancer treatment

30

Protein biomarker information for chemotherapy, targeted therapied, and antibody-drug conjugats.

72

Absolute quantification of protein expression level

Clinical grade quality control

CAP-accredited and CLIA-certified clinical proteomics laboratory and approval from the New York State Laboratory Evaluation Program (CLEP)

OncoOmicsDxTM Assay Introduction

Patient-specific tumor proteome forpersonalized cancer treatment

OncoOmicsDx™ can simultaneously analyze theexpression of 30 or 72 tumor-associated proteins, providing absolutequantification data. This high-resolution proteomic information helps predict apatient’s potential response to various therapies, including chemotherapy,targeted therapy, and antibody-drug conjugates (ADCs). It serves as a powerfultool to support clinicians in developing personalized treatment strategies,ultimately enhancing therapeutic efficacy and patient outcomes.

For example:

 

l   HER2 protein expression serves as acritical biomarker for selecting anti-HER2 therapies such as trastuzumab.

l   TOPO1 expression can predict theresponse to topoisomerase I inhibitors like irinotecan.

l   TUBB3 levels help assess the potentialefficacy of certain microtubule-inhibiting chemotherapeutic agents, such as taxanes.

l   MGMT (O6-methylguanine-DNAmethyltransferase) expression is closely associated with response totemozolomide, making it an important indicator for evaluating temozolomidetreatment in patients with glioblastoma multiforme (GBM).

 

We hold over40 global patents and have tested more than 10,000 clinical samples. Throughthis, we have built a clinically validated mass spectrometry-based proteomicdatabase focused on 72 cancer-related proteins. Through absolutequantification of multiple target proteins using proteomics analysis,OncoOmicsDx™ enables a more comprehensive understanding of tumor cell proteinexpression profiles in clinical practice. 

Certified U.S.-based Clinical ProteomicsLaboratory

The U.S.-based Clinical ProteomicsLaboratory is certified by CAP, CLIA, and the New York State Department ofHealth (NYSDOH), meeting the highest international standards for clinicalquality and regulatory compliance. All testing procedures and biomarker analysesundergo rigorous validation in accordance with CAP/CLIA/NYSDOH requirements,ensuring the accuracy, reliability, and clinical applicability of the results.

 

Based on a high-resolution massspectrometry platform, our laboratory performs absolute quantification of 72clinically validated tumor-associated proteins with established clinicalcut-off values. This provides a scientific and reliable foundation for medicaldecision-making, supporting the implementation of high-quality precisionmedicine.

 

Rapid Turnaround with clinical relevance

Results delivered within 14 calendar days,meeting clinical timelines (counting from the receipt of a qualified sample atthe laboratory).

 

Expert Report Consultation Service

One-on-one consultation for personalized testreports, providing a detailed explanation of the analysis results.

Expert Team for Precise Interpretation

Our team consists of specialists in tumorbiology, medicine, molecular biology, cell biology, immunology, bioinformatics,big data analytics, and pharmacology. By integrating bioinformatics databases,we deliver in-depth interpretation of protein expression data, providingcomprehensive analysis and treatment recommendations.

Summary

OncoOmicsDxTM Assay – Thetechnology

Comprehensive personalized molecularsolution to inform cancer care

Compared to traditionalimmunohistochemistry (IHC), OncoOmicsDx™ leverages mass spectrometry (MS)combined with targeted proteomics technology to deliver more accurate andconsistent absolute quantification data. IHC is a semi-quantitative methodprone to variability due to subjective interpretation, sample quality, andstaining conditions, and is typically limited to analyzing one or a few targetsat a time. In contrast, mass spectrometry enables simultaneous analysis ofdozens of protein biomarkers, improving diagnostic efficiency and significantlyincreasing data density and clinical relevance—providing robust support forprecision medicine.

 

The OncoOmicsDx™ testing platform utilizesa high-resolution mass spectrometer in combination with Multiple ReactionMonitoring (MRM-MS) and Data-Independent Acquisition (DIA) techniques toquantitatively analyze target proteins.

 

During the analytical process, specificmass spectrometry transitions are designed for each peptide fragmentcorresponding to the target protein. These are paired with high-purity stableisotope-labeled internal standards to establish dedicated chromatographicseparation and signal acquisition protocols. Absolute quantification is achievedby comparing the area ratios of chromatographic curves between the analyte andits internal standard.

 

This approach offers the followingtechnical advantages:

 

  • High Sensitivity and Selectivity:The MultipleReaction Monitoring mass spectrometry (MRM-MS) technique enables accuratedetection of low-abundance target proteins in complex biological samples,significantly reducing interference from non-specific background signals.
  • High Reproducibility and QuantitativeAccuracy:Internal standards are used for calibration, enhancing dataconsistency across different samples and analytical batches.
  • High-Throughput Multiplex DetectionCapability: By integrating Data-dependentAcquisition (DIA) with Triple Quadrupole Mass Spectrometry (QQQ-MS), theplatform can monitor dozens of proteins, enabling efficient and precisemultiplex quantitative analysis for targeted protein expressions. 

Eligible patient characteristics:

  1. Cancer patients in stages III to IV who are facing complex treatment decisions
  2. Individuals seeking to implement precision chemotherapy strategies, using protein expression analysis to support drug selection     and treatment planning.
  3. Patients exploring options beyond standard treatments, such as those who have not responded to existing therapies or cannot tolerate them.

 

 

Use cases:

  • Evaluation of protein biomarkers associated with chemotherapy
  • Evaluation of protein biomarkers related to targeted and immunotherapy
  • Assessment of protein markers relevant to antibody-drug conjugates (ADCs)
  • Tumor prognosis assessment
  • Evaluation for other treatment options

 

Cancer types:

  • Breast cancer
  • Head and neck cancer
  • Esophageal cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Biliary tract cancer / Cholangiocarcinoma
  • Gastric cancer
  • Ovarian cancer
  • Endometrial cancer
  • Malignant sarcoma
  • Cervical cancer

 

Technical Specifications

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Documentation

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Disclaimers / Footnotes

  1. Turnaround time starts from the date of receipt of approved samples at our CAP-accredited laboratory.
  2. Please refer to our specimen instructions.

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