ASTERAND® Accredited Human Tissue Products is a new option for people who need a quality, board-certified pathology-confirmed diagnosis but have limited data available.
Details
Available for the majority of solid tumor indications.
- Low-data set that includes data on gender, age, race, year of excision, and organ of excision
- Same ASTERAND Board-certified Pathology Review for confirmed tissue diagnosis
- Same ASTERAND ethical collections with links to regulatory documentation included
- Same ASTERAND Human Tissue Quality with links to Aperio full slide image
- Percent tumor count is guaranteed to fall between 25-100 %
- Low user failure rating – consistently less than 1 % for over 20 years and for over 1,000,000 processed samples
Source: BioIVT
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ASTERAND Accredited Human Tissue |
ASTERAND Elite
Human Tissue |
| Board-Certified Pathology Review to confirm specimen diagnosis |
Confirmed specimen diagnosis |
Confirmed specimen diagnosis with tumor grade |
| Link to high-resolution, whole slide images of specimens using Leica Biosystems’ Aperio System |
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| Ethically procured – Links to regulatory documentation included |
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| Associated Socio-demographic Data Set |
Donor Age, Gender, Race |
Donor Age, Gender, Race, Ethnicity, Smoking history, Alcohol history, Female reproductive history, and more |
| Associated Clinical Data Set |
Resection organ,
year of resection |
Comprehensive
>300 data points inclusive of clinical donor diagnosis, comorbidities, treatments (current and past), medications |
| Associated Specimen Data Set |
Percent tumor between 25-100% guaranteed |
Comprehensive
including percent tumor, necrosis, normal and other; ischemic time, specimen size/weight |
| Associated Outcomes Data |
NA |
Available for some cohorts,
inquire for more information |
| Lowest user failure rate |
<1% |
<1% |
| Tissue formats available |
FFPE Only |
FFPE, Fresh Frozen w/ matched biofluids |
Quality
Specifications
- The standard procedure demands that tissues be removed and processed in less than 30 minutes of cold ischemia time.
- Fixed samples are immersed in 10% neutral buffered formalin for at least 4 hours to achieve complete fixation but no more than 72 hours.
- For quality control, at least one portion of each tissue block is excised and stained with H&E.
- Board-certified pathologists assess tissue to confirm that its origin and diagnosis are congruent with clinical data.
- Tissue quality and integrity are assessed based on paraffin quality, tissue size, and processing quality.
- The Sample Level Tumor (STMR) is established for malignant samples.
- Normal tissue cellular composition is used to calculate the percentage (%) of parenchyma in the sample
- BioIVT is dedicated to upholding essential bioethics principles, including autonomy, privacy, safety, and informed consent. The company actively supports legal and ethical initiatives that encourage 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 after surgeries performed for medical treatment. Instead, BioIVT has built a global network of collaborators responsible for subject recruitment, obtaining informed consent, and conducting scientific activities. BioIVT ensures that all activities carried out by the company itself and its collaborators comply with relevant laws, regulations, and ordinances. BioIVT confirms that its collaborators have completed necessary procedures such as obtaining institutional and independent review board approvals, privacy officer authorizations, government licenses, and industry accreditations. Furthermore, BioIVT continuously monitors its practices to ensure that they align with evolving external scientific, legal, and ethical standards.