Simply meeting regulatory standards is not enough for you to remain competitive in today’s evolving immune-mediated inflammatory disease (IMID) drug market. When it comes to FDA approval and successful commercialization of IMID drugs, the consistency of your data is critical. In addition, biopharmaceutical companies such as yours need the ability to detect and quantify small effects, secondary results, potential additional indications, and other insights that can enhance the value of your products.
Covance Central Laboratory Services (Covance CLS) offers extensive in-house capabilities and dedicated support for a variety of key assays used in IMID trials to ensure you obtain unmatched data consistency. One such assay that we perform in-house is the Anti-Nuclear Antibody Indirect Fluorescence Assay, or ANA-IFA – a sensitive screening test used to detect autoimmune diseases.
Anti-Nuclear Antibodies (ANAs)
Antinuclear Antibodies, or ANAs, are usually found in patients whose immune system is generating immunemediated inflammatory response against their own body tissues. The presence of ANA is of great importance in prevalent auto-inflammatory diseases such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis. The ANA testing is also useful as part of the exclusion criteria for some inflammatory disease clinical trials when autoimmune diseases in general are to be ruled out.
ANA-IFA: The “Gold Standard”
In 2009, the American College of Rheumatology (ACR) deemed the ANA-IFA test as the “gold standard” for ANA testing. In keeping with the ACR’s recommendation, Covance uses the ANA-IFA test for all of its ANA screens, performing over 15,000 such assays per year.
The Pros and Cons of Immunofluorescence (IFA)
Since the 1950s, indirect immunofluorescence has been used to detect ANAs. The IFA methodology offers numerous advantages, including the ability to detect in excess of 100 auto-antibodies. IFAs are also beneficial in that they provide both ANA pattern and titer information.
When ANA tests are conducted via IFA assays, antibodies, if present, produce fluorescent patterns in cells that have been fixed to glass slides and examined under a microscope. These staining patterns offer clues as to which particular antinuclear antibody or antibodies may be present.
Nonetheless, the IFA method comes with some challenges as well. Resulting of the test is done manually, by a technician reading the slides under a microscope, and scoring the fluorescence patterns against reference patterns. Furthermore, the workflow of processing patient samples into stained slides ready for interpretation can be time-consuming with low throughput, and is known for producing its share of false negatives for certain auto-antibodies.
Standardizing the ANA-IFA Methodology
In an effort to deliver globally-consistent, high-quality data from your ANAIFA tests, Covance CLS centralized all of our ANA-IFA testing to only two sites; created consistent standard operating procedures and training; and adopted state-of-the-art automation techniques.
ANA-IFA testing is done in our Indianapolis facility, with the exception of samples originating within mainland China. These samples are processed in our Shanghai lab, due to the current limitations on exporting whole blood, tissue, or any other DNA-containing biological samples from China. Our strategy of concentrating our ANA-IFA testing into only two locations provides you with increased result consistency. In addition, we wanted you to benefit from using our central lab in China, rather than a local lab where quality and experience in running this type of assay might not be up to the required level.
In Indianapolis, where most of our ANA-IFA testing is done, our technicians all have more than five years of experience in reading these assays. At our Shanghai laboratory, in order to maintain seamless data delivery, we provided high-level training to our Shanghai technicians. This included on-site training and e-learning to demonstrate visually how our technicians perform the assay in Indianapolis.
In addition to customized training materials and tools, both of our sites use consistent standard operating procedures, including the Pattern Plus Auditor® system from BioRad Laboratories, Inc., the kit manufacturer. This system provides a common pattern reference guide and reinforces our ability to provide consistent interpretations of results.
Driving all of our ANA-IFA assay volume to two sites has also allowed us to take full advantage of the benefits derived from automated lab processes. Using robotic technology to prep the ANA-IFA slides promotes cost efficiency while improving consistency in sample handling.
Your choice in selecting a central lab can have a significant impact on the success of your IMID drug development efforts. While Covance CLS is a high volume clinical trial testing laboratory, offering more than 550 assays, we also have the flexibility and scalability to develop, validate and provide specialized assays such as the ANA-IFA assay.
Our approach to standardizing and automating the ANA-IFA assay is just one example of how we go above and beyond to ensure globally combinable data and high-quality results. It also demonstrates how automated lab processes can maximize consistency and scalability while minimizing costs. Finally, it shows how producing high-quality data across multiple clinical trial sites requires advanced levels of technical and scientific knowledge, plus dedicated process oversight.
For more information about how Covance CLS can assist you with the design and execution of your clinical trials, please contact your account executive or visit our website for more information: http://www.covance.com/cls.