Lung cancer FFPE and fresh frozen samples were reviewed by a board-certified pathologist, clinical data was collected, and the IRB approved the study.
Details
BioIVT’s bank of lung cancer tissue specimens provides access to both prospective and retrospective tissue collection. It also allows for the collection of specimens using tailored procedures depending on research or can ship conventional collections right away.
With available board-certified pathology confirmation of disease and determination of percent tumor, necrosis, and inflammation, users can rest assured that they are working with the exact specimens that their research requires. Standard and custom clinical data collection and confirmation also ensure precise corresponding staging, treatment, and outcome data.
Included diagnoses
Non-small Cell Lung Cancer (including all subtypes of Adenocarcinoma and Squamous Cell Carcinoma), Small Cell Lung Cancer and Other Neuroendocrine Lung Tumors, Lung Cancer.
Standard biorepository collections
Clinical data obtained through a rigorous and consistent clinical data method is supplied to the easily accessible FFPE and Fresh Frozen samples. To verify diagnosis and quality, all specimens undergo evaluation by board-certified pathologists and are examined for IRB authorization. Certain donors are available with related blood-based biofluids.
For diagnostic and early-phase researchers, BioIVT now offers ASTERAND Accredited Human Tissue. This features the same board-certified pathology review and the same quality inspection with a limited data set.
Pre-screened specimens
BioIVT provides FFPE and frozen tumor specimens that have been pre-screened for mutations that relate to cancer research. The tested specimens include:
- Tumors of non-small cell lung cancer examined for EGFR and KRAS mutations
Custom collections
BioIVT offers a personalized custom collection service tailored to researchers' specific needs for more defined requirements. Samples can be collected in various preserved formats, including fresh and unpreserved samples. BioIVT can also accommodate tailored protocols, specific consent requirements, and necessary accompanying clinical information upon request.
Features and benefits
- Blinded IRB and Consent is available for all specimens collected under IRB approval
- Board-certified Pathology review of all tissue blocks
- Clinical data review, including stage confirmation
- Ethical collection of human specimens
- Histological quality check of all tissue blocks
- Multiple formats available: Mirror, Matched w/Adjacent Normal, Quad Set, with matched biofluids
- Standard collection protocol across all prospective sites
Quality
Specifications
Biohazard Information: Handle this material as if it is capable of transmitting infectious agents. Universal precautions must be undertaken. No diagnostic technique can guarantee the absence of the Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, or other infectious agents. As a result, all biological products provided by BioIVT should be handled at Bio-Safety Level 2 as suggested by the CDC/NHI Manual “Biosafety in Microbiological and Biomedical Laboratories, From Potentially Infectious Human Serum Or Blood Specimens.”
For in vitro usage only. The user is entirely responsible for its use and disposal in accordance with all regulations.
BioIVT is committed to upholding fundamental bioethics principles, including autonomy, privacy, safety, and informed consent. The company actively supports legal and ethical initiatives aimed at encouraging the voluntary donation of surplus human tissues and clinical information for research purposes.
Typically, the tissue received by BioIVT is surplus surgical tissue that would otherwise be discarded post-surgery conducted for medical treatment. BioIVT has instead established a global network of collaborators responsible for subject recruitment, obtaining informed consent, and conducting scientific activities. It is imperative that all activities undertaken by BioIVT and our collaborators adhere to relevant laws, regulations, and ordinances.
BioIVT ensures that necessary procedures such as institutional and independent review board approvals, privacy officer authorizations, government licenses, and industry accreditations have been obtained by collaborators. Additionally, BioIVT consistently monitors its practices to ensure alignment with evolving external scientific, legal, and ethical standards.
- The standard process requires tissues to be excised and processed with less than 30 minutes of cold ischemic time.
- Fixed samples are placed in 10% neutral buffered formalin for a minimum of 4 hours to ensure thorough fixation but no longer than 72 hours.
- One section (minimum) is removed from each tissue block and stained with H&E for quality review.
- Tissue is evaluated by board-certified pathologists to ensure tissue origin and diagnosis are consistent with clinical data.
- Tissue quality and integrity are characterized by paraffin quality, tissue size, and processing quality.
- Sample Level Tumor (STMR) is determined for malignant samples.
- Normal tissue cellular composition is evaluated to estimate the percentage(%) of parenchyma present in the sample.