Test Overview
Test Methodology

NGS (Next Generation Sequencing) of DNA and mRNA; proprietary algorithms and processes; patented LCE (Laser Capture Enrichment) isolation of specific microsubpopulations of FFPE.

Test Usage

Provides precise actionable information about the specific cancer pathways in the patient and associations between the pathways and the specific drugs available that can impact the cancer to allow for more effective decision-making. Paradigm provides custom analysis as well as a broad-spectrum analysis of over 500 nucleotides of interest including Next-Gen Sequencing for DNA mutations, DNA copy number variation, DNA chromosomal inversions, deletions, translocations and mRNA expression. The analysis is driven by supporting data and literature.

Reference Range *

Interpretive report provided.

Test Details
Days Set Up
Monday - Friday
Analytic Time

4 - 5 days

Soft Order Code
MiChart Code
PCDx, Paradigm Cancer Diagnostic
  • Paradigm NGS Test
Specimen Requirements
Collection Instructions

Submit a formalin-fixed, paraffin block of tissue containing greater than 40% tumor (minimum 20%); store at room temperature. One of the following samples should be provided: 1. FFPE Block from the most recent surgery or biopsy, containing the most amount of tumor, excluding bone. 2. Incisional or Excisional Biopsy: Biopsies formalin-fixed, paraffin-embedded in a single block 3. Core Needle Biopsy: Biopsies formalin-fixed, paraffin-embedded in a single block 4. Shaves/Curls: Six to ten 10 um thick curls along with H&E stained section of same block. Tissues should be fixed within one hour of surgical resection. The optimal total fixation time is 12-24 hours, using only neutral-buffered formalin. Fixed tissues should be thoroughly dehydrated prior to the embedding process. To access the PCDx requisition, please see: http://www.paradigmdx.org/pcdx/order-pcdx/

Special Handling

For detailed collection and shipping instructions, please see http://www.paradigmdx.org/wp-content/uploads/2014/04/ParadigmPCDxSpecim…. Tissues should be fixed within one hour of surgical resection. Storage of blocks without cut faces prevents ongoing damage from exposure to oxygen, water, light and other environmental factors.

Rejection Criteria
Paradigm does not accept bone or de-calcified specimens.
Normal Volume
75 mm3 (5 mm x 5 mm x 3 mm) or 4 to 6 needle biopsies containing 40% tumor
Minimum Volume
1 needle biopsy containing 20% tumor (may be unable to complete full profile with minimum specimen)
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs/Paradigm to report the test results to the ordering clinician.

NY State Approved