Question 1

What is Paradigm's PCDx Test?

Accepted Answer

The PCDx test is a Next-Generation Sequencing (NGS) based diagnostic genomic 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.

Question 2

Which patients are most appropriate for Paradigm’s PCDx testing?

Accepted Answer

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.

Question 3

What will the PCDx report indicate?

Accepted Answer

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.

Question 4

What sample types can be utilized for PCDx testing?

Accepted Answer

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.

Question 5

What sample size is required for PCDx testing?

Accepted Answer

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)

Question 6

What is the required sample tumor content?

Accepted Answer

Optimal: 40% or Higher Minimum: 5%

Question 7

When can I expect my patient’s testing results?

Accepted Answer

Once your sample is received for testing, test results should be available within 5 business days.

Question 8

Where is the testing performed?

Accepted Answer

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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