A BLOOD TEST FOR REAL-TIME DIAGNOSTICS


Revolutionary and non-invasive method for detection and monitoring of oncogenic mutations with a simple blood test.

IntPlex® surpasses all existing technologies for sensitivity and specificity of somatic mutation detection and cost-effectiveness.

The ultrasensitive IntPlex® assay has been the first to detect more mutations from the blood of metastatic patients than from standard tumour tissue analysis. This superior performance is pivotal for clinical decision making and it is backed up by an increasing body of evidences from independent studies, published in top-tier journals:

    • Circulating DNA analysis provides a more comprehensive genetic picture of the entire tumour mass, evaluating the somatic mutation profiles of the primary tumour and its metastases at the same time, within the same sample.

    • Circulating DNA analysis provides a real-time snapshot of the tumour dynamics.

    • Tumour heterogeneity is a widely described phenomenon, with spatially distinct tumour clones harboring different genetic changes involved in tumour progression and response to treatment.

    • Intra-tumour heterogeneity can hardly be detected with standard tissue biopsy: important genetic alterations may hence be missed depending on the tumour area sampled.

    • Since novel genetic changes can accumulate over the course of tumour progression and as escape mechanisms to targeted treatment, metastases-specific mutations will not be present in the original diagnostic specimen.

    As such, standard tissue biopsy will miss a number or actionable mutations that can instead be detectable from circulating DNA. By performing circulating DNA analysis with our ultrasensitive IntPlex® method our customers can maximise the detection and monitoring of any somatic mutations of interest.


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ROBUST

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RAPID

SIMPLE

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HIGHLY SENSITIVE

Circulating cell-free DNA analysis constitutes a powerful approach to provide a non-invasive molecular test for cancer patients. Based on the discovery of different structural features of circulating DNA between oncological patients and healthy individuals, we developed a method to accurately determine the mutational status of various oncogenes.

The proprietary IntPlex® technology was specifically developed to fulfill the unmet need of an ultrasensitive analysis of circulating DNA.

DiaDx: leader in blood-based oncology testing


  • More than 15 years of extensive research on circulating DNA: Development of IntPlex®

  • Best-in-class technology and extensive clinical validation through peer-reviewed publications

Strategies for building value



Our offers:
  • RUO service provision platform for the detection of actionable mutations from plasma and other body fluids, tailored for clinical centres and private laboratories.

  • Companion diagnostic services (CDx) for pharmaceutical companies: DiaDx multi-parametric analysis on a customisable selection of circulating DNA biomarkers can help monitoring the patient response to new compounds, from preclinical studies to phase III clinical trials.

  • R&D contracts or partnership agreements with the Pharmaceutical industry for the development of exclusive IntPlex® assays for better patient stratification and effective indication of use for new targeted treatments.

  • Ready-to-use CE/IVD kits (IntPlex® BRAF V600+ and IntPlex® EGFR T790M) compatible with any quantitative PCR instruments and easily implementable in every clinical laboratory.

  • Personalised RUO kits (see our constantly expanding mutation portfolio): DiaDx mix-and-match system guarantees fully customisable and cost-effective solutions to meet any particular research exigencies of our customers.

IntPlex® test using circulating DNA as a diagnostic tool has many advantages over conventional analytical techniques

What makes our test unique ?



DiaDx offers a revolutionary advance for personalised cancer care.


We provide, with a simple blood draw, a multiparametric, qualitative and quantitative analysis of tumour-derived circulating DNA with unprecedented sensitivity level.


It makes it possible to detect and track tumour molecular dynamics before, during and after the course of treatment.


IntPlex® has been validated on more than 1000 plasma samples from various cancer patients: its high repeatability and reproducibility guarantee unsurpassed analytical performances.


Due to its unprecedented sensitivity and specificity levels, IntPlex® enables ultrasensitive detection of somatic mutations in cancer patients, for optimal patient stratification and a foreseeable improvement in the treatment response rate.


DiaDx has built a strong expertise in all pre-analytical conditions revolving around an optimal circulating DNA analysis and follows its own stringent Standard Operating Procedures under Good Clinical Laboratory Practice (GCLP) guidelines.


By combining our in-depth knowledge on circulating DNA structures with the respect of rigorous pre-analytical conditions we perfected a technology with unsurpassed sensitivity and specificity.

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Real-time molecular snapshot of cancer

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Unprecedented sensitivity

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Personalised analysis

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Simple, convenient, rapid and cost-effective

Real-time snapshot of the overall tumour molecular profile


Because of intra- and inter-tumour heterogeneity, tumour-tissue analysis represents a sub-optimal choice as it focuses on just a small tumour section.


Thanks to our IntPlex® ultra-sensitivity it becomes possible to detect a large portfolio of somatic mutations from existing solid and liquid cancers, providing a true snapshot of the disease at any time a blood test is required to assist the oncologist's decision making.

IntPlex® enables the molecular profiling of the primary tumor and its metastases within one single blood sample.

Unprecedented sensitivity levels

IntPlex® proprietary technology enables the qualitative and quantitative detection of down to one mutant circulating DNA fragment, bypassing the limits of any other technique for circulating DNA and tumour-tissue analysis. Thus, IntPlex® analysis is only limited by the number of circulating DNA fragments existing in the patient's blood.

Personalised analysis

IntPlex® proprietary technology allows for the multiparametric, qualitative and quantitative analysis of circulating DNA before, during and after the course of treatment. Our published data showed (i), the strong prognostic value of IntPlex® analysis and its usefulness for following-up patients; and (ii), the utility of tracking mutations conferring drug resistance for clinical guidance and optimal treatment. As such, IntPlex® provides a real-time analysis of the molecular evolution of the tumour providing information on the mutant clones dynamics during all phases of patient management care.

Convenient, rapid and unmatched low cost

IntPlex® analysis requires two blood collection tubes and no tissue specimens.

Unsurpassed rapidity : Data turn around time = two days

IntPlex® is a sophisticated quantitative PCR-based method much more cost-effective (2 to 3-times) than any other competitor system.

Personalised cancer medicine is a reality with IntPlex®.

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