Description:

• 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.

  
  

Specimen Requirements:

• 2 Streck Cell Save tubes for CellSearch®

Handling & Shipping:

1. Request a Test Collection Box from Protean.

2. Instructions on how to collect and ship a sample are included in the Test Collection Box.

3. CellSave/CellRescue® collection tubes Instructions provided for Use.

   Contact a blood collection site to have plasma collected based on instructions and materials provided in the Collection Box. (Contact Protean if phlebotomy services are required.)

4. COLLECT & SUBMIT THE SAMPLE

   a. Pre-addressed, pre-paid FedEx label and material to securely send sample(s) to the MSB lab.

   b. FedEx UN3373 Pak for this Biological Substance, Category B (UN 3373) shipments.

   c. The collection box includes everything needed to collect a sample and ship it safely to the MSB lab.

There are several steps that need to be completed before and after a patient’s blood sample is collected for the test and specimen transportation process to work properly.

Turnaround Time: 7-10 days

Description:

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

• Helps patients at risk of prostate cancer make informed decisions about the need for prostate biopsy.

Specimen Requirements:

• Blood sample, spun down

• 2 SST serum tubes

  • Stable for 5 days at 2 to 8 °C

  • Stable for 24 hours at 20-25 °C 

  • Freeze at -20 °C or refrigerate at 2 to 8 °C immediately after blood is spun down*

  • Storage temperature is site specific

Handling & Shipping:

1. Request a Test Collection Box from Protean.

2. Instructions on how to collect and ship a sample are included in the Test Collection Box.

3. Collection tubes instructions provided for Use.

4. Contact a blood collection site to have serum collected based on instructions and materials provided in the Collection Box. (Contact Protean if phlebotomy services are required.)

5. COLLECT & SUBMIT THE SAMPLE

   1. Ship centrifuged serum OVERNIGHT to Protean BioDiagnostics with dry ice.

   2. Pre-addressed, pre-paid FedEx label and material to securely send sample(s) to the Protean BioDiagnostics lab.

   3. FedEx UN3373 Pak for this Biological Substance, Category B (UN 3373) shipments.

   4. The collection box includes everything needed to collect a sample and ship it safely to the Protean BioDiagnostics lab.

There are several steps that need to be completed before and after a patient’s blood sample is collected for the test and specimen transportation process to work properly.

Turnaround Time: 3-5 Days

Description:

• 3D genomic analysis using Hi-C

Specimen Requirements:

• Minimum 10 slides OR tissue block(s) that allows for 10 slides to be cut from it.

• Slide details:

  • unstained unbaked slides

  • 5 micron thick sections.

  • DO NOT BAKE SLIDES.

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 10-15 Days

Description:

• Epigenetic profiling is a powerful method of molecular analysis to improve the classification of tumors.

• Classification for CNS, brain, and other tumors.

Specimen Requirements:

• Minimum of 20 slides OR tissue block(s) that allow 20 slides to be cut from it.

  Slides should be:

  • Unstained & unbaked

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

  • H&E is optional

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 10-15 Days

Description:

• 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.

Specimen Requirements:

• Minimum of 2-3 slides OR tissue block(s) that allows for 2-3 slides to be cut from it.

• Slides should be:

  • Unstained & unbaked

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

  • H&E is optional

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 1-2 Days

Description:

• DISH for HER2 (ErbB2 copy number) in breast, gastric, colon, and other tumors.

Specimen Requirements:

• Minimum of 2-3 slides OR tissue block(s) that allows for 2-3 slides to be cut from it.

• Slides should be:

  • Unstained & unbaked

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

  • H&E is optional

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 1-2 Days

Description:

• A pan-cancer highly sensitive blood test.

• Evaluates 1229 cfRNA mutations and 1004 cfDNA mutations.

Specimen Requirements:

• 2 Streck Cell Free DNA blood collection tubes

Handling & Shipping:

1. Place filled blood tubes in holder.

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

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

4. Store at room temperature.

5. Overnight delivery.

Turnaround Time: 10-15 days

Description:

• 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.

Specimen Requirements:

• 10 unstained sections

Handling & Shipping:

• Regular shipping.

Turnaround Time: 5-10 Days

Description:

• Enables rapid, reliable detection of MGMT Promoter Methylation from FFPE tumor tissue.

Specimen Requirements:

• Tissue block, or minimum of 5 slides.

• Slides should be:

  • Unstained & unbaked

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

  • H&E is optional

Handling & Shipping:

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

• Overnight shipping is required for tissue blocks.

• Regular shipping for slides.

• Include all required documentation

Turnaround Time: 3-5 days

Description:

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

• Accurately measures hPG80 (circulating progastrin), which is elevated in blood samples from patients with various types of cancer compared to healthy individuals.

Specimen Requirements:

• Frozen plasma or whole blood.

• Frozen plasma details:

  • 2-4 mLs of frozen plasma

  • 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

Handling & Shipping:

Note: 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, and shipped at -20°C

• 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. 

• Ship between +2°C and +8°C.

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

• Ship overnight to Protean. 

Turnaround Time: 3-5 days

Description:

• 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.

Specimen Requirements:

• Patient Pathology Report

  • Email (encrypted) or fax the Pathology Report to Protean BioDiagnostics

Turnaround Time: 10-15 Days

Description:

• ProCvix is a high-sensitivity screening test targeting E6/E7 DNA of 14 high-risk HPV types for improved risk stratification, and higher specificity for triage and disease progression.

Specimen Requirements:

• Liquid Based Cytology (LBC) Samples Conserved in PreservCyt (ThinPrep®, Hologic) and Cyt-All (Cytomega) Transport Media

  OR;

• First-void urine (the initial part of the urine stream) collected in Colli-Pee device.

Handling & Shipping:

• LBC - ThinPrep® Sample:

  • Specimen should be packed with cool gel packs.

  • Each specimen should be packaged in its own biospecimen bag with moisture absorbent material (i.e. paper towel).

  • Each specimen should be clearly labeled with specimen ID.

• Urine Sample:

  • Specimen should be packed with cool gel packs.

  • Each specimen should be packaged in its own biospecimen bag with moisture absorbent material included (i.e. paper towel).

  • Each specimen should be clearly labeled with the specimen ID.

Turnaround Time: 3-5 days

Description:

• DNA & RNA test analysis of over 600 genes.

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

Specimen Requirements:

• Minimum 10 slides, or Tissue blocks that allow for 10 slides to be cut from it.

• Slides should be:

  • 5 micron thick sections

  • DO NOT BAKE SLIDES

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 10-15 days

Description:

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

Specimen Requirements:

• 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.

Handling & Shipping:

• 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. .

Turnaround Time: 3-5 days

Description:

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

Specimen Requirements:

• Minimum 10 slides, or Tissue blocks that allow for 10 slides to be cut from it.

• Slides should be:

  • 5 micron thick sections

  • DO NOT BAKE SLIDES

Handling & Shipping:

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Turnaround Time: 1-2 days

Description:

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

Specimen Requirements:

• Thyroid Tissue Sample. Tissue Sample

• Contact QualisureDx for more details:
  www.qualisuredx.com

Turnaround Time: 10-30 days

Description:

• 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:

• 1 preservative tube containing cheek swab.

Handling & Shipping:

• 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 Time: 20-30 days (30-40 for whole exome)