Test Ordering Information & Descriptions

To order, please contact a customer coordinator at support@proteanbiodx.com or 1 (754) 242 9682
or download a
test requisition form and fax to 877-764-7628


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 Description of All Tests

    • Isolates, counts, and analyzes circulating tumor cells.

    • Ideal for monitoring patients with breast, colon or prostate cancer.

    • Also measures protein expression of HER2, ER (estrogen receptor), PDL1 in circulating tumor cells.

    • Clarity Dx for Prostate is a decision support tool that provides a risk score based on clinical and biological biomarkers.

    • Helps to make informed decisions about need for prostate biopsy for patients with elevated PSA levels.

    • 3D genomic analysis using Hi-C

    • Methylation profile analysis is a powerful method of molecular analysis to improve the classification of tumors.

    • Classification for CNS, brain, and other tumors.

    • Immunohistochemistry identifies protein levels in tissue cells.

    • Combination of histology and immunology that helps pathologists diagnose diseases, such as cancer, and predict treatment responses.

    • Particularly useful for antibody drug conjugates, for example HER2, PDL1 etc.

    • In situ hybridization (ISH) is a laboratory technique that finds and identifies specific DNA or RNA sequences in cells.

    • Provides insights into gene function and disease processes.

    • HER2 copy number.

    • A pan-cancer highly sensitive blood test.

    • Evaluates 1229 cfRNA mutations and 1004 cfDNA mutations.

    • Full coverage of NCCN recommended variants for lung cancer.

    • Biomarkers covered: EGFR, ALK, KRAS, ROS1, BRAF, NTRK1/2/3, METex14 skipping, RET, and HER2.

    • Additionally, PD-L1 testing is recommended to guide the use of immune checkpoint inhibitors.

    • Results provided in as little as 2-3 days.

    • OnkoSkan™ is a non-invasive blood test to help detect and monitor cancers.

    • The OnkoSkan™ lab test accurately measures hPG80 (circulating progastrin), which is elevated in blood samples from patients with various types of cancer compared to healthy individuals.

    • The first and only clinically validated biomarker for metastatic colorectal cancer.

    • PersonaCRC assesses the risk of spread, recurrence, and overall survival, to help clinicians identify the most effective treatment strategies and improve patient outcomes.

    • DNA & RNA test analysis of over 600 genes.

    • Measures mutations, copy number changes, fusions, TMB & MSI in FFPE tissue.

    • A prostate cancer decision support tool that provides a risk score based on clinical and biological biomarkers. 

    • Evaluates ALK, RET, ROS1, NTRK 1,2,3, and MET exon14 skipping mutation in FFPE tissue.

    • A prognostic test that helps surgeons and endocrinologists to make important decisions on the clinical management of papillary thyroid cancer.

    • Protean’s exclusive whole exome genetic test for hereditary cancer, that covers over 22,000 Genes

    • Focused gene panels are available for all cancer types.

    • Protean also offers a comprehensive panel that includes all of the currently known genes associated with hereditary cancer risk.

    • Information can also be used for bioinformatics, pharmacogenomics, and other inherited syndromes.


Specimen Requirements

 
    • 2 Streck Cell Save tubes for CellSearch®

    • Tissue block or minimum 10 slides.

    • Slide details:

      • unstained unbaked slides

      • 5 micron thick sections.

      • DO NOT BAKE SLIDES. 

    • Tissue block, or minimum of 20 slides.

    • Slides should be:

      • Unstained & unbaked

      • Tissue size: 25 mm2 (if less than this size, please provide more slides)

      • H&E is optional

    • Overnight shipping required for tissue blocks. 
      Regular shipping for slides.

    • Tissue block or 5 unstained slides per test.

    • Slides should be:

      • 4-5 micron thick sections

      • Unbaked and mounted on positively charged slides

    • 2 streck Cell-Free DNA blood collection tubes

    • 10 unstained sections

    • Frozen plasma or whole blood.

    • Frozen plasma details:

      • 2-4 mLs of frozen plasma

      • Shipped at -20°C

        Note for plasma processing:

        If whole blood cannot be centrifuged immediately, while waiting to be shipped store blood collection tubes between +2°C and +8°C, protected from light, and if possible, in a vertical position, for a maximum of 48 hours (2 days) including no more than 4 hours at room temperature. Spin down when possible. Do not freeze whole blood.

    • Whole blood details:

      • 8 mLs of whole blood

      • Collected in K2-EDTA or K3-EDTA tubes

      • Shipped between +2°C and +8°C

    • Tissue block or 8-10 slides.

    • Slides should be:

      • 5 micron thick sections

      • DO NOT BAKE SLIDES

    • 2 mL of frozen serum in a transport tube.

    • Serum collected using standard sampling tubes or tubes containing separating gel. (SST Gold Top Tube)

    • Note: Do not collect specimens after a transrectal biopsy since results may be falsely elevated.

    • Tissue block or 5 unstained slides per test.

    • Slides should be:

      • 5 micron thick sections

      • DO NOT BAKE SLIDES

    • 1 preservative tube containing cheek swab.

 

Handling & Shipping

    • Ship in a cooled container or with room temperature gel packs, with pathology report.

    • Overnight shipping required for tissue blocks. 

    • Regular shipping for slides.

    • Place filled blood tubes in holder.

    • Place holder containing blood tubes into the biohazard bag and back into the shipping box.

    • Place box into enclosed, pre-labeled shipping bag.

    • Store at room temperature.

    • Overnight delivery.

    • Ensure that all tubes are labelled with PHI and Unique Facility ID, and that duplicate Facility ID Label is adhered to page 1 of the TRF in the Unique Facility ID Box.


    Frozen Plasma: 

    • Frozen plasma must be packaged with dry ice. 

    • Shipping label must state that dry ice is included in the shipment (see FedEx Biological Shipping Instructions). 

    • Ship overnight to Protean. 

    Whole Blood

    • Whole blood should be packaged with cold gel packs only. DO NOT FREEZE whole blood. 

    • Ensure special labeling for blood included (see FedEx Biological Shipping instructions). 

    • Ship overnight to Protean. 

    • The serum should be frozen after collection and remain frozen until ready to be shipped. 

    • Must be shipped with FROZEN ice packs, in an insulated box. 

    • Ship in under 5 days at 2‑8°C. 

    • Please label the tube with the patient’s first and last name, DOB, and collection date.

    • Place tube into the shipping box, place box into enclosed, pre-labeled shipping bag.

    • Store at room temperature.

    • Overnight delivery.


Turnaround Times

 
Service/Test Turnaround Time

CellSearch® (CTCs)

7-10 days

FusionPlus (3D Genomics)

10-15 days

Global Methylation (includes MGMT)

10-15 days

Immunohistochemistry (IHC)

1-2 days

Liquid Trace™

10-15 days 

Lung HDPCR™

5-10 days

Protean 600+

10-15 days

Rapid Analysis Fusion Panel

1-2 days

Risk MAPS™

20-30 days (30-40 for whole exome)

Cancer Screening Test/Service Turnaround Time

OnkoSkan™

3-4 days

Prostate: Free & Total PSA

3-4 days

ClarityDx for Prostate

3-4 days

PROcVix

3-4 days

Pathology Services Turnaround Time

Second Opinion Patient Consultations

10-30 days

 
 
 

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