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 our central Ohio facility and also partners with a variety of other clinics across the US to help provide researchers with an enormous variety of banked, prospectively collected and postmortem tissue samples, biofluids, extracted nucleic acids. We also provide other kinds of normal or diseased, fresh and frozen human samples, including serum, plasma, whole blood, solid tumor material, CSF and other biospecimens.
• 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.
• If you need Asian samples, we also have access to one of the only sources of quality Chinese biospecimens that is ofﬁcially approved by the Chinese government. Each shipment is explicitly approved by the Chinese Ministry of Trade.
• 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”, or “Honest Broker”. This important industry role allows us to act as qualified intermediary and compliance auditor, equipped specifically to prevent patient identifying data crossing from the clinical world into the research world.
• Specimens are managed in-house using a custom built, state-of-the-art data tracking system. The system allows us to screenour collection and create custom cohorts based on complex combinations of clinical and biomarker inclusion and exclusion criteria as speciﬁed by our clients. 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 biospecimen procurement, 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.
• Biomarker information that was collected as part of US clinical standard care is immediately available for many specimens. Where that information is NOT available we have the capability to determine biomarker status in-house, or we can offer you the more economic option of providing you with sections only from a large number of cases, which you can then screen yourself. You can then purchase blocks of interest.
• We can also provide advanced histopathology and microscopy services such as custom staining and sectioning of both FFPE and frozen tissues, as well as professional IHC and ISH / FISH studies, screening for markers of interest, Aperio slide scanning, advanced histology image analysis and more. We are also actively involved in a range of histology research activities aimed at developing and improving new histologic techniques and approaches. One of our research projects has led to a totally new process for improving the IHC staining characteristics of FFPE specimens exceeding 10 – 15 years of age.
• 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