• 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.

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

• 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.

Steps:

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.

Steps:

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 plasma 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 plasma 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.

Requirements:

• Minimum 10 slides, or

• Tissue blocks that allow for 10 slides to be cut from it

Ship to Protean BioDiagnostics

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

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

• Overnight shipping required for tissue blocks. 

• Regular shipping for slides.

Requirements:

• Minimum 2-3 slides, or

• Tissue blocks that allow for 2-3 slides to be cut from it

Ship to Protean BioDiagnostics.

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Requirements:

• Minimum 2-3 slides, or

• Tissue blocks that allow for 2-3 slides to be cut from it

Ship to Protean BioDiagnostics.

• 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. 

Requirements:

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

• 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. 

Requirements:

• Minimum 10 slides, or

• Tissue blocks that allow for 10 slides to be cut from it

Ship to Protean BioDiagnostics.

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

Requirements:

• Minimum 10 slides, or

• Tissue blocks that allow for 10 slides to be cut from it

Ship to Protean BioDiagnostics.

• Overnight shipping required for tissue blocks.

• Regular shipping for slides.

• 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.

Requirements:

• Tissue Sample

• Contact QualisureDx for more details (https://qualisuredx.com/)