Center for Advanced Laboratory Medicine (CALM)

CALM is a center developed to serve as the conduit between researchers and the hospital clinical laboratories at Columbia University Irving Medical Center. Our mission is to collaborate with researchers to effectively support all clinical laboratory-related study needs. We also specialize in partnerships with industry collaborators to conduct assay development and clinical trial studies, including early assay research and development, pre-market evaluations, 510(k) clinical trials, and post-market studies. Our areas of expertise include the following:

• Clinical Microbiology and Infectious Disease Diagnostics
• Clinical Chemistry and Serology
• Hematology
• Coagulation
• Molecular Diagnostics
• Blood Banking and Immunohematology
• Point-of-Care Testing

Our operational staff are licensed by the American Society for Clinical Pathology and strive for accuracy in results, pay attention to detail, and provide a quick turn-around-time with the services that we offer. CALM medical technologists and all staff members have access to, and actively collaborate with, the faculty members within the Pathology and Cell Biology Department here at Columbia University Irving Medical Center. We also have doctoral-level expertise in assay development, validation, translation, and implementation. Our knowledgeable and creative group will thoughtfully develop solutions for your research needs.

CALM Leadership Team

Eldad Hod, M.D., and Greg Berry, Ph.D., D(ABMM) are Co-Directors of the CALM. Dr. Hod is a Professor of Pathology and Cell Biology and is a board-certified Clinical Pathologist. He is also the Vice Chair of Laboratory Medicine and Medical Director of Clinical Laboratories, with over 15 years of expertise in blood banking, clinical chemistry, and hematology testing. Dr. Berry is an Associate Professor of Pathology and Cell Biology and is a board-certified Clinical Microbiologist. He is also the Medical Co-Director of the Clinical Microbiology Laboratory, including the specialties of infectious disease molecular diagnostics, virology, bacteriology, diagnostic immunology, mycobacteriology, mycology, and parasitology.

Richard Francis, M.D., Ph.D. and Alex J. Rai, Ph.D., DABCC, FAACC are the Associate Directors of the CALM.  Dr. Francis is an Associate Professor of Pathology and Cell Biology and Medical Director of Hematology and Coagulation.  Dr. Rai is a Professor of Pathology and Cell Biology, Medical Director of Chemistry. Both also oversee point-of-care testing in their respective areas.

Together, this group of leaders will ensure the highest quality of results for your testing needs.

Our Services

The CALM laboratory currently offers the following services:

• Sample Procurement – We have access to all specimens received in the NewYork-Presbyterian Hospital Laboratories at CUIMC.
• Laboratory Testing – Available for both research use, FDA-approved, and CLIA-certified clinical tests.
• New Assay Validation – We ensure that results are provided with accuracy and reliability.
• New Instrument Validation/FDA New Device Approval Studies – We can help validate and perform the FDA approval studies for your new device, including all needs related to 510(k) clinical trials (testing, honest broker, chart review, CRF documentation, documentation maintenance and retention, audit support).
• Sample Processing, Shipping, Handling, and Temporary Storage – We have flexible space and freezers to handle, process, store, and ship samples.
• Phlebotomy – CALM is equipped with phlebotomy stations and phlebotomists from 8:30 a.m.–4:00 p.m., Monday-Friday.
• Data Management – Data is stored in secure, encrypted databases, accessible for review through protected web access.

We will provide the highest quality results at competitive, reasonable rates.

Healthy Blood Products

For access to a variety of blood products from healthy blood donors (e.g., whole blood, buffy coats, mononuclear or hematopoietic cells, etc.), please see the following link:

Comprehensive Cell Solutions

Collaboration

If you are interested in a collaboration, please email CALM@columbia.edu to begin the process.