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Personalized medicine depends on tools, such as immunohistochemistry (IHC), that identify precise targets in a patient’s disease. Immunohistochemistry (IHC) staining is integral in developing personalized medicine as it enables researchers to identify different biomarkers present in any given tissue sample. “IHC is a powerful tool in clinical diagnostics, enabling accurate histologic subtyping of malignancies,” says Dr. Cullen Taylor M.D., Medical Director of Biospecimen Solutions at Precision for Medicine. “Many IHC markers also inform treatment and prognostic, or risk-stratification, decisions.” Consequently, Taylor and his colleagues use IHC to help partners develop diagnostic tools that enhance the treatment of patients.
The wide range of targeting molecules and diverse clinical applications require access to millions of diverse samples and cutting-edge IHC platforms. Precision for Medicine’s facility in Winston-Salem, NC, houses a biorepository and IHC lab. This lab houses the three industry-leading platforms: Dako/Agilent Autostainer Link 48, Dako/Agilent Omnis, Leica Bond-III, Leica Bond-MAX, and Roche/Ventana BenchMark ULTRA. These platforms are duplicated at other Precision for Medicine Laboratories.
Simultaneous access to biospecimens and IHC technology offers crucial benefits. “In the research arena, IHC is a cost-effective modality used to drive biomarker discovery,” Taylor says. “Combined with our large tissue biorepository, we are uniquely positioned to accelerate the pace of discovery for our client’s programs.”
Applying the IHC lab
Precision for Medicine applies its multiple IHC laboratories in various ways. First, the IHC lab relies on the biorepository to pull samples with specified diagnoses and biomarkers that fulfill a client’s experimental parameters.
The development of diagnostics makes up another application of Precision for Medicine’s IHC labs. When a company is developing studies for an antibody to be used as an in vitro diagnostic (IVD), Taylor says, “We contract with them and do all of the lab testing on their platform with their antibody.” If a similar IVD that is already on the market was tested on a different IHC platform, Precision for Medicine can compare the performance of the new antibody on one platform versus an existing antibody on another. “The advantage here is that we’ve got the sample access, we do the comparative work, and then our pathologists are available to read the samples,” Taylor explains. “So, we have that capability from start to finish.”
Precision for Medicine can work with a customer at even earlier stages with the development of new antibodies. In these cases, Precision for Medicine runs the first IHC tests on the antibody, optimizes it, and validates it. The Biospecimen Solutions team can optimize experimental variables, such as, pH conditions, the antigen-retrieval time, consumables, or the IHC platform itself. The goal is to produce an antibody IHC procedure that optimizes the signal-to-noise ratio on every slide. To produce high quality research, “you want an appropriate signal intensity localized to the area of interest,” Taylor says.
For a new antibody, Precision for Medicine can partner with a customer throughout the research process, starting with the development of a new antibody IHC procedure, all the way to providing support during clinical trials. “For us, this work has been growing tremendously, and there’s an incredible need in the industry,” Taylor says. “Every week, there’s a new opportunity in this arena.”
A testicular cancer case study
To delve deeper into Precision for Medicine’s capabilities, Dr. Cullen Taylor uses testicular cancer as an example. Customers come to Precision for Medicine with new potential biomarkers, such as a biomarker over-expressed in testicular cancer. “Although there are many variants of testicular cancer,” Taylor says, “we can very quickly get the samples together and start screening them to identify positive controls, negative controls, and the range of expression.”
To select the appropriate testicular-cancer samples, Precision for Medicine works with the customer. “There are several common testicular diseases and then additional rare subtypes,” Taylor says. “So, in collaboration with the client, we find the right samples to validate their antibody and match what they expect to do in the trial.”
The selected samples are used to prepare a tissue microarray (TMA) which aggregates a collection of tissue samples into one slide. “Large, carefully selected tissue cohorts from our biorepository can be screened efficiently using IHC on custom-prepared TMAs,” Taylor explains. “The TMA approach is not only cost effective but enables testing of a large number of samples under the same controlled test conditions.” From this work, Precision for Medicine provides full IHC optimization, CLIA-validation, and sample access. “We do it all under one roof, often with the end point of supporting clinical trial work once validated,” Taylor says.
However, testing just the target tissues is not enough. Precision for Medicine also runs tests on normal tissues to assess any toxicity when the antibody is used to deliver a drug. Taylor affirms that, “Again, it’s our sample access that’s critical to these studies, and we have the pathologists to read the standards, which is really the issue at the clinical level.”
One feature that makes Precision for Medicine stands out is keeping all IHC studies under one roof. “We don’t have to collaborate with another entity to get our samples and the services,” Taylor says. “It’s a time consuming process for clients to try to obtain samples, and it’s the quality of the samples and the services that matter, because that generates your data.”
To get the desired data, collaboration is crucial. “There are typically several calls with a customer to get a project set up, collaboratively, and weekly calls to make sure we’re aligned,” Taylor says. “There’s intense collaboration that goes into every project, and that makes the difference in the outcome.”