Client Specific Prospective Sera Collections
De-Linked Residual Diagnostic Specimens:
Assay ranges/values to meet your specific R&D purposes not just what's available from existing specimen bio-repositories built on past requirements and speculation.
Through collaborations with Private and Hospital Reference Laboratories, Bay State Biologicals has access to > 80,000 general chemistry residual diagnostic sera specimens monthly. Residual diagnostic sera can be utilized for R&D purposes; FDA regulated In-Vitro Diagnostics (IVD) R&D, Biomarker discovery, Biomarker Assay Validation/Correlation, Genomic/Proteomics Discovery. Individual specimens are de-linked with a waiver of consent (45CFR46.11d) protocol in place approved by a Local IRB and is renewed annually. Residual materials are made available to Bay State Biologicals immediately upon release by requesting physicians or clinics for further screening. To help ensure the highest possible integrity of each specimen, materials are frozen immediately after processing and stored at -20ºc or - 80ºc at the Reference Laboratory facilities. Specimens are shipped to Domestic and International locations frozen, in dry-ice and in accordance to IATA regulations.
Please see attached file to review a list of General Chemistry Assay's of which Bay State Biologicals has access to the residual material. Some assay's listed are send outs and residual material would not be available.
Click here to see our general chemistry assays.
Autoimmune, Diabetes, Anemia, Heart Disease, Cancer markers, Thyroid/Endocrinology, Therapeutic Drug Monitoring. OB/GYN
| Troponin CKMB BNP Cholesterol Cortisol CEA CRP Rubella Negative <5.0 IU/mL B-12 Ferritin Folate FT3 FT4 FSH |
LH Myoglobins Progesterone Prolactine T3U TT3 TT4 TSH PSA Free PSA CA125-II RF ANA SCL-70 |
Bay State Biologicals serum, plasma and CSF materials have been obtained in the United States with IRB approved protocols in place to protect all individual patient rights.
Clinically defined well-characterized patient specimens along with companion data can help &
- Appraise surrogate markers and disease mechanisms in-vitro
- Assess relevant gene/protein/cell based targets to develop successful therapies
- Identify effective biomarkers for early disease detection
- Develop functional assays that can enhance clinical trials
- Available for immediate delivery
- Neurology (Whole Peripheral Blood, Serum/Plasma and CSF individual or matched sets)
- Alzheimer's disease, Parkinson's disease & other MCI Disorders.
- Multiple Sclerosis, Variants & Age matched "Normal" Control Patients.
- Cardiology
- Hyperlipidemia, Hypertension, Cardiomyopathy, Myocardial Infarction and other related
- Acute Coronary Syndromes.
- Atherosclerosis, Platelet Disorders and Diabetes.
Client Specific Prospective Sera Collections:
Bay State Biologicals collaborates with FDA Licensed Blood Donor Centers, HealthCare Groups, Local Hospitals, Multiple Out Reach Centers, Thirty Nursing Homes, and a network of dedicated physicians eager to participate in promising new research projects that could potentially benefit patient care and outcomes. Clinical Regulatory Services are available to develop the required Protocol/IICF documents for submission to local and central IRB's prior to initiating prospective patient studies/enrolments. After receiving written confirmation from the IRB of acceptance of both protocol and IICF Bay State Biologicals will initiate the approved site/s, monitor and audit site/s while providing regular updates to sponsors ending with close out of the project.
- Autoimmune
- Cardiology
- OB/GYN
- Oncology
- Neurology
- Matched "Normal" Control Populations