Biospecimen Capabilities

Summary of Lab-Ally LLC Biospecimen Procurement and Lab Services Capabilities

• Lab-Ally partners with a variety of research and diagnostic laboratories and biospecimen procurement organizations including a fully CLIA certified research lab based in central Ohio, USA. The Lab-Ally sales office is co-located in the same facility as this CLIA certified lab.

• Our partner’s lab facility has multiple capabilities including ISH, FISH, IHC, ELISA, genomics and FDA regulated studies. As such, this facility is subject to US state and federal inspections and is required to maintain the highest standards of quality and compliance in all aspects of its operation. The facility also includes one of the largest commercial FFPE block biobanks in the US.

• Lab-Ally can access almost 7 million FFPE blocks stored in this central Ohio facility and also partners with a variety of other clinics across the US to help provide researchers with an enormous variety of tissue samples, biofluids, extracted nucleic acids, and other biospecimens of all kinds.

• Our biospecimen collection represents the entire gamut of pathology specimens collected by participating hospitals and as such, is statistically representative of the US population at large. Specimens include all tissues and indications typically collected as part of clinical standard care, and examples of both diseased and normal samples representing diverse age, gender and racial groups. Attached clinical data is extensive and follow-up potential is excellent since we have embedded data mining specialists at the originating hospitals who have on-demand access to pertinent medical records with the full cooperation of the participating clinics under the auspices of each clinic’s own IRB as well a blanket IRB issued by Quorum.

• All banked FFPE specimens are de-identified in compliance with US state and federal regulations, including 45 CFR 46. The biobank division is categorized as a “trusted third party”, meaning that its role is to act as a compliance auditor, equipped specifically to prevent patient identifying data from crossing from the clinical world into the research world.

• Biospecimens are managed in-house using a custom built, state-of-the-art data tracking system. The system allows us to screen specimens for complex combinations of inclusion and exclusion criteria specified by our clients, and assemble cohorts of specimens to your exact specifications. We can even provide a web portal to clients that allows them to monitor the progress of their studies and see the history of their previous studies.

• Our customers include many of the world’s largest pharma and life science research companies. Our international reputation for quality US-sourced specimens, service excellence and ethical practices has allowed us to become the exclusive preferred vendor for many of these organizations.

• Not only do we provide required specimens for our clients but if necessary, we can also perform entire studies in our CLIA certified labs so that the specimens never leave our facility.

• We can also provide advanced histological services such as custom staining and sectioning, screening of sections for markers of interest, advanced imaging, image spectrometry and microscopic services, Aperio slide scanning and more.

• We specialize in assembling very large cohorts of biospecimens representing specific cancer indications and extremely hard to find neurological specimens such as CNS and brain samples, but our collection includes all other diseases and conditions in quantities that are reflective of the both the US population and the full range of samples, biopsies and surgical material that is collected by the standard of care at modern US hospital pathology labs.

• All samples undergo stringent QC processing in a CLIA certified environment by a board certified pathologist and research oriented histologists.

• We warranty our tissue. All specimens will match your requested pathology and histology based criteria, communicated in advance to us, or we will replace them at our cost.

FOR MORE INFORMATION OR TO DISCUSS THE FULL RANGE OF CAPABILITIES PLEASE CALL ROB DAY AT
(US) 614-407-4547

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