Ethics

Do you collect bio-samples from consented donors only?

All donors are protected by anonymity and legal Informed Consent documents, which clearly state medical research purposes and possible benefits to scientific discovery and humanity. Clinical specimens can only be obtained with signed Patient Consent.

How do you protect donor’s confidentiality?

Stringent procedures are followed to ensure volunteers'/donors' privacy and confidentiality protection, including coding system for all the biomaterials and associated clinical information, so that the donor's identity is kept anonymous.

Do you have (IRB/IEC) approval for samples collection?

All clinical samples are obtained following official protocols, with appropriate Institutional Review Board/Independent Ethical Committee (IRB/IEC) approval, which operates in accordance with the current Federal Regulations in addition to ICH, HIPPA, and GCP guidelines pertaining to protection of human subjects.

Fresh frozen tissue samples

What is fresh frozen tissue sample size/weight?

Standard sample weight is 0.5 - 1 gram. Tissue samples of 2-3 gm are available upon request.

What is the time between surgery/ biopsy and tissue samples freezing?

All fresh/frozen tissue samples are collected by certified medical pathologists and are snap-frozen in liquid nitrogen within 30 minutes of surgery excision.

What QC do you perform for fresh frozen tissue samples?

The following QC procedures are performed on 100% of collected fresh frozen tissue samples:

Pathology QC:
H&E slides preparation from each fresh frozen tissue sample by independent pathologists for tissue evaluation and diagnosis confirmation.

RNA QC:
Extraction of total RNA is performed on all fresh frozen samples collected for ProteoGenex. RNA is analyzed using the Agilent Bioanalyser 2100.

Clinical data QC:
All data are carefully reviewed for accuracy and completion.

Do you prepare FFPE blocks matching fresh frozen tissue samples?

Formalin-fixed paraffin-embedded tumor and normal adjacent tissue matching fresh frozen tissue samples are available.

What samples can you collect from one patient?

In addition to fresh frozen and FFPE tissue samples we can collect various biological fluids (serum, plasma, whole blood, PBMC, urine, saliva, etc.) from the same patient.

Biofluids

What human biofluid samples can you collect?

Plasma , serum , whole blood collected in PAXgene RNA and DNA tubes, BM, urine, saliva, sputum, amniotic fluid, CSF, etc.

Can you perform samples collection in client's tubes?

ProteoGenex is able to perform collection using client's collection tubes/ kits.

Do you collect viable cells from blood or BM?

Separation and freezing down of viable WBC are performed using ProteoGenex SOP or SOP provided by clients.

Do you collect samples from patients with hematological malignancies?

We collect Blood and BM specimens from patients with Hematological diseases:
Leukemia: ALL, CLL, AML, CML
Lymphoma: NHL, Hodgkin's disease
Multiple myeloma
Myelodysplastic syndrome

Blood/BM samples can be collected at different stages of a disease.

FFPE blocks

What method of fixation do you use for FFPE blocks preparation?

All FFPE tissue samples are fixed in 10% neutral-buffered formalin within 30 minutes of surgery excision and embedded in IHC-grade paraffin.

What is a standard FFPE block sample size?

Standard FFPE block size is 1x1x0.5 cm, but can vary depending on the nature of a disease and tissue type.

What information do you provide for FFPE blocks?

Each FFPE block is accompanied with the following information:

ID # Age Sex Race Histological diagnosis Differentiation grade TNM

Stage Location of distant metastasis Number of analyzed lymph nodes Number of positive lymph nodes Tumor size Date of surgery Treatment history (if applicable)

Do you perform IHC staining?

We provide IHC services on human tissues to identify specific cell types in which your target proteins are expressed.

Do you prepare TMA blocks?

ProteoGenex provides custom-built Tissue Microarrays.

What are core sizes for TMA blocks you provide?

Core sizes are 0.6 mm, 1 mm, and 2 mm.

How many cores per one block can you prepare?

Up to 400 cores per TMA block.

Do you provide blocks with follow-up information?

We can prepare blocks or cut sections from blocks with up to 5 years follow-up information.