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Mark Manak, Ph.D.

Chief Scientist, Department of Laboratory Diagnostics and Monitoring

Dr. Mark Manak heads up the research activities of MHRP’s Department of Laboratory Diagnostics and Monitoring, focusing on evaluation of diagnostic assays and their applications in screening for HIV and related infectious diseases and monitoring efficacy of intervention programs. Dr. Manak has extensive expertise in development and validation of in-house and commercial assays for HIV and related infectious diseases and their use in diagnostic, epidemiological, vaccine and therapeutic programs.  

Dr. Manak has helped set up and direct various collaborative programs with developers of infectious disease tests including Hologic, Roche, Bio-Rad, SpotOn and SeraCare as well as partnerships with government agencies for evaluation of diagnostic assays and devices. A major focus is on clinical evaluation of specificity, sensitivity, linear dynamic range, accuracy and reproducibility to meet stringent CAP/CLIP requirements. 

Studies included performance evaluation of HIV Rapid tests, 4th generation HIV-1/2 Ag/Ab Combo tests, Aptima other serological and molecular tests used in manual or automated formats. Results of these studies helped guide the selection and validation of most effective test algorithm for sensitive and reliable detection of HIV infection, including detection of early acute infection.

Dr. Manak has led numerous clinical studies conducted under IRB approval for assays used for detection of infection, monitoring natural progression and response to therapeutic intervention. A recent study evaluated the performance of HIV Nucleic Acid assays on Roche, Abbot and Hologic platforms for accurate detection and quantification of HIV subtypes throughout the world. Other studies included use of rapid tests for HIV, HBV and HCV for emergency field testing of the “Walking Blood Bank” in military operations; use of dried blood spots for collection of specimens in the field for testing of HIV, Dengue, West Nile Virus and Chikungunya Virus; and molecular assays for monitoring Chlamydia trachomatis, Neisseria gonorrhoeae, Ebola virus, and other infectious agents in epidemiology and vaccine research studies. The results of these studies help guide the establishment of monitoring and intervention protocols used by the U.S. Department of Defense and the U.S. and global medical community.

Prior to Joining MHRP, Dr. Manak was the Chief Scientist of SeraCare Life Sciences Inc., where he led the development of seroconversion and performance panels widely used by the in vitro diagnostics community for development, evaluation and validation of in vitro diagnostic assays used in screening and monitoring of infectious diseases. He served as the Director of Biospecimen Repositories, housing over 30 million clinical specimens used for studies of HIV, HCV, HBV and other infectious diseases sponsored by NIAID, NCI and NHLBI, as well as many other government and industry clients. Dr. Manak also led NIH-sponsored studies on evaluation of the global diversity of HIV, evaluation of antiviral and vaccine initiatives, and development and validation of diagnostic tests used in monitoring infectious diseases.

Dr. Manak received his Ph.D. in Biochemistry and Biophysics, from the University of Connecticut, and did postdoctoral studies at Johns Hopkins in molecular events in control of viral infections. He is an expert in diagnostics of infectious diseases with over 76 publications, and he frequently presents results of diagnostic studies at scientific conferences.