QualTek Molecular Laboratories
QualTek is an industry leader in the field of immunohistochemistry (IHC) and its vast applications. Our mission is to provide the highest quality IHC biomarker and tissue-based assay services to support and accelerate research and clinical studies with pharmaceutical and biotechnology partners. QualTek’s capabilities cover a broad spectrum of research and clinical studies in various therapeutic areas including oncology, inflammatory, metabolic, neurologic, and cardiovascular diseases and disorders. Our experience and understanding of applied IHC allows us to integrate IHC data into various stages of the dynamic drug development process from basic research to testing of Phase I-III clinical samples to development of Companion Diagnostics.
The founders of QualTek previously established BioTek Solutions in 1989; a company that designed instrumentation and detection systems to automate assays for immunohistochemistry (IHC) and in-situ hybridization (ISH). These instruments were sold worldwide, primarily to clinical pathology laboratories. BioTek Solutions merged with Ventana Medical Systems resulting in a successful IPO in 1996. Out of this experience, QualTek Molecular Laboratories was founded in 1997 to fill a need for expertise in IHC assays and analyses in the research and clinical communities within biotechnology and pharmaceutical companies.
QualTek has worked on over 1,500 studies and has a thorough understanding of IHC and histopathology. These studies include testing pharmacodynamic (PD) and predictive biomarkers on clinical and research samples. QualTek has developed hundreds of assays and has tested and analyzed well over two hundred thousand tissues from our extensive Tissue Bank and from patient samples for clinical studies. QualTek services include:
QualTek is owned and operated by scientists who are truly experts and pioneers in the field of IHC with proven, long-term success working with pharmaceutical and biotechnology companies. The founding members of QualTek, Steve Bernstein, PhD and Frank Lynch, PhD are still actively involved in its daily operation. Our staff includes a cohesive group of PhD-level scientists, accredited histotechnicians, board-certified pathologists, and an experienced Quality Assurance Unit with hundreds of years of combined experience in IHC applications.
QualTek not only develops the highest quality assays, but also has high-throughput capability to analyze tissue samples using automated instrumentation overseen by our well-trained staff of IHC experts. We run an estimated >25,000 IHC stains in a given year. QualTek has established and maintains a comprehensive Quality Assurance Program and complies with specific regulatory requirements and standards as required by our study sponsors.
QualTek's varied services are supported by two fully equipped Laboratory locations in Santa Barbara, CA (CAP/CLIA accredited) and Newtown, PA (GLP capable) servicing North America, Europe, Asia, and South America.
Publications with QualTek Contributing Authors
Cancer Manag Res.: Glucocorticoid receptor expression in 20 solid tumor types using immunohistochemistry assay.
Block TS, Murphy TI, Munster PN, Nguyen DP, Lynch FJ. Mar 6;9:65-72. doi: 10.2147/CMAR.S124475. eCollection 2017
Arch Pathol Lab Med.: Development of a Prototype Immunohistochemistry Assay to Measure Programmed Death Ligand-1 Expression in Tumor Tissue. Dolled-Filhart M, Locke D, Murphy T, Lynch F, Yearley JH, Frisman D, Pierce R, Weiner R, Wu D, Emancipator K. 2016 Nov;140(11):1259-1266.; doi: 10.5858/arpa.2015-0544-OA
Cancer Manag Res.: Development and validation of an immunohistochemistry assay to assess glucocorticoid receptor expression for clinical trials of mifepristone in breast cancer. Baker GM, Murphy T, Block T, Nguyen D, Lynch FJ. 2015 Dec 4;7:361-8. doi: 10.2147/CMAR.S91546. eCollection 2015.
Immunohistochemistry assays in Good Laboratory Practice Studies
F. Lynch, S. Bernstein and H, Battifora
Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
Editors: Uma Prabhakar & Marian Kelley, Wiley, 2008. ISBN: 978-0-470-02876-6
Molecular Pathology: Immunohistochemistry assays in drug development performed by a contract research laboratory
F. Lynch and S. Bernstein
Molecular Pathology in Drug Discovery and Development
Editor: J. Suso Platero, Wiley, 2009 ISBN: 978-0-470-14559-3