ExpertAsia-improving patient outcomes - Introducing PCDx - targeted diagnostics for oncology patients
What is Paradigm’s PCDx test?
The PCDx test is a custom sequencing- based diagnostic genetic test that offers a more targeted, personalized approach to cancer treatment by interrogating and identifying the underlying genomic and proteomic alterations of a patients tumor’s DNA, RNA & protein. The information provided by this test assists ordering physicians in developing a more informed and individually tailored treatment strategy for a patient’s cancer.

What are the clinical advantages of Paradigm’s PCDx test?
The Paradigm’s NGS-based PCDx tumor profiling test provides three key clinical advantages:
  • Fast Turnaround: Clinical report delivered in 5 business days to ensure continuity of clinical care.
  • High Confidence: Average depth of coverage is >5000x to ensure accuracy of sequencing calls
  • Comprehensive: PCDx analysis includes mutations, copy number variations, mRNA expression, fusions / isoforms and protein expression to ensure the most comprehensive look at the patient’s genomic landscape.

Which patients are most appropriate for Paradigm’s PCDx testing?
The Paradigm PCDx test is typically utilized for patients when first-line or second-line treatment or standard of care options are not working. This is typically referred to as “refractory” disease. PCDx is also utilized for patients with cancers that are rare or of an aggressive nature with limited treatment options. Ultimately, however, it is up to the ordering clinician as to whether PCDx testing may be appropriate for your patient.

What will the PCDx report indicate?
The PCDx Report will provide the following information:
  • A picture of your patient’s genomic landscape (DNA mutations, mRNA expression, copy number variations, fusion/isoforms and protein expression), highlighting all actionable alterations identified.
  • Potential therapeutic options for your patient based on key biomarkers detected, including associated levels of evidence.
  • A succinct, yet integrated consultative discussion of the patient’s genomic analysis generated by  oncologists team.  This analysis will also include data gathered from the patients medical and treatment history.
  • Potential targeted clinical trials based upon the patients individual test results.

When can I expect my patient’s testing results?
Once your sample is received for testing, test results should be available within 5 business days.

What sample types can be utilized for PCDx testing?
The Paradigm PCDx test may be performed on the following:
  • FFPE Block: Standard formalin-fixed, paraffin-embedded (FFPE) block from most recent surgery or biopsy, containing the most amount of tissue, excluding bone.
  • Shaves/Curls: 6-10 10μm thick freshly cut curls along with H&E stained section of same block.
  • Slides: 7-25 (depending on the offering selected) 4μm, freshly cut, unstained, unbaked sections on positively charged slides or (1) slide per IHC requested.Formalin-fixed not decalcified blocks only.

What sample size is required for PCDx testing?
  • Optimal: 75mm (5 mm x 5 mm x 3mm) or 4 to 6 needle biopsies
  • Minimum: One core needle with 5% tumor (10 mm x 2 mm x 1 mm) (risk that full profile cannot be completed)

What is the required sample tumor content?
  • Optimal: 40% or Higher
  • Minimum: 5%

Where is the testing performed?
The Paradigm PCDx test is performed at its  CLIA certified laboratory in Phoenix, AZ to ensure the highest standards of laboratory practice. Furthermore, each individual report is reviewed and commented on by an experienced oncologist and pathologist in a fashion intended to clarify the results for the ordering physician to aid in their decision making.

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