Division of Clinical Chemistry

Clinical chemistry faculty, fellows, residents, and technologists participate in a variety of ongoing research initiatives, ranging from the discovery of new biomarkers to the development and analytical validation of new diagnostic assays.

Advanced Clinical Chemistry Diagnostics Laboratory +

The Advanced Clinical Chemistry Diagnostics Laboratory provides CLIA-certified patient testing for tumor markers and drug monitoring and conducts a variety of research and development projects in Reference Chemistry and Clinical Mass Spectrometry. The Reference Chemistry laboratory is directed by Drs. Chan and Sokoll, and the Clinical Mass Spectrometry laboratory is directed by Dr. Clarke. Projects include the support of clinical studies through testing of specimens as well as the development and analytical evaluation of clinical assays and new technologies. Visit the Advanced Clinical Chemistry Diagnostics Laboratory website for more information and contacts.

ACCDL website screenshot

Center for Biomarker Discovery & Translation +

The Center for Biomarker Discovery & Translation (CBDT) was founded in 2000 by Dr. Daniel W. Chan, Director of Clinical Chemistry Division and Co-Director of Pathology Core Laboratories. The intended purpose was to discover and validate novel biomarkers for the detection, diagnosis, classification, management and understanding of human diseases, with emphasis on the development of clinical diagnostics for major types of cancers. Early achievements include the discovery of a panel of biomarkers for ovarian cancer, which was cleared/approved by the FDA in 2009 as the clinical test OVA1.A second generation test, OveraTM, was cleared by the FDA in March of 2016. CBDT has continued to evolve and is currently one of three select labs involved in the Clinical Proteomic Tumor Analysis Consortium (CPTAC) launched by the National Cancer Institute (NCI). CPTAC is a comprehensive and coordinated effort to accelerate the understanding of the molecular basis of cancer through the application of robust, quantitative, proteomic technologies and workflows with the goal of improving the ability to diagnose, treat and prevent cancer. In 2011, CBDT was awarded the CPTAC center at Johns Hopkins - "Proteome characterization center: a genoproteomics pipeline for cancer biomarkers" with Drs. Daniel W. Chan, Hui Zhang and Zhen Zhang as Principal Investigators. Another NCI initiative that CBDT is actively involved with is the Early Detection Research Network (EDRN), which brings together dozens of institutions to help accelerate the development and translation of biomarkers into clinical diagnostics and evaluate new ways of testing cancer in its earliest stages along with cancer risk. The EDRN and its industrial partners have successfully obtained FDA clearance/approval for 5 cancer diagnostics for clinical use, with the CBDT being involved in the discovery, validation and/or clinical study for 3 out of those (OVA1, proPSA as phi, and PCA3 as Progensa). Other ongoing projects at the forefront of clinical research conducted at the CBDT include:

  • Glycoconjugates and cardiovascular disease
  • Mechanism of anti-cancer activity of SCFA-hexosamine analogs
  • Clinical and analytical validation of cancer biomarkers
  • Johns Hopkins proteomic innovation center in heart failure

The CBDT is equipped with state of the art proteomic instruments including six mass spectrometers, 5 HPLC systems and two multiplex immunoassay systems. More information, including group members and publications, may be found at the Center for Biomarker Discovery & Translation website.

CBDT website screenshot

Clinical Pharmacology Analytical Laboratory (CPAL) +

Dr. Marzinke is the Director of the Clinical Pharmacology Analytical Laboratory (CPAL), a translational research core located within the Department of Medicine (Division of Clinical Pharmacology) at the Johns Hopkins University School of Medicine. Dr. Marzinke's group is focused on the development, validation, and implementation of bioanalytical tools to support pre-clinical and clinical research trials. The CPAL focuses on technologies to assess pharmacokinetic-pharmacodynamic (PK-PD) relationships, and has expertise in anti-infectives, including HIV and tuberculosis (TB)-related pharmacology. The CPAL contains research space on both the EBMC and the BMC. CPAL activities at the EBMC are focused on specimen processing, scintillation counting, and ex vivo explant and subsequent PD studies. BMC activities are focused on high-throughput liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. Dr. Marzinke's group currently has six LC-MS/MS analyzers to provide high-throughput drug quantification. Research expertise within the laboratory also included the development and validation of quantitative LC-MS/MS assays in alternative matrices, including breast milk, cerebrospinal fluid, cervicovaginal fluid, rectal fluid, tissue, and whole blood collected on dried blood spots. All assays are validated in accordance with FDA, Guidance for Industry: Bioanalytical Method Validation recommendations.

Dr. Marzinke's laboratory serves as the primary pharmacology laboratory for the HIV Prevention Trials Network and the Microbicide Trials Network. Dr. Marzinke and his group are also part of the Center for AIDS Research Clinical Laboratory and Biomarkers Core and the Institute for Clinical and Translational Research Drug Analysis Unit.

For questions regarding small molecule quantification and pharmacokinetics and adherence testing, please contact Dr. Marzinke at .