CLIA ID #: 34D2295704

CAP ID # 983112501

Manoj Tyagi

PhD Clinical Biochemistry
President and Chair, Board members at Carolina Diagnostic
Labs LLC

Based at Raleigh/Durham North Carolina and has been Member of ADLM (formerly AACC) since 2013, an active committee “Member at Large” NC local section ADLM, Fellow ADLM academy and full member at Society of Forensic Toxicology (SOFT) since 2016. Board certified NRCC Clinical Chemistry, Current Vice president NRCC board. Dr Tyagi has been involved in clinical biochemistry/ toxicology, with numerous published articles and given national and international presentations in area of clinical biochemistry and toxicology.

Clinical Consultant (2013 to 2023)

Implemented and validated testing procedures for detecting drugs of abuse in urine and oral fluid specimens applying Scientific working group for forensic toxicology (SWGTOX) and FDA CLIA /CAP and CLSI guidelines. Managed, controlled and sustained quality, efficiency and productivity of lab operations; recognized for expertise as Positive Certifying Scientist for Urine, blood and oral fluid specimens. Expanded drug testing menus to keep up with the ever-changing illicit drug market.

Implemented new technologies that improved analytical capabilities and production throughput. Wrote the SOPM (standard operating procedure manual), detailing step-by-step procedures to assist technicians; this manual also supported the validation process. Directed time/labor and accountability; successfully reduced costs while maintaining quality production. Train, mentor and support internal clients in methodology and instrumentation.

Medical Laboratory Director, CSO (2014 to present)

Manage direct reports from Technical directors; Molecular diagnostics, Genetic testing (PGX), Toxicology and Blood testing in the development, implementation, and operation of a therapeutic drug monitoring panel for Urine, blood and saliva specimens.
Improve performance of laboratory analyses by adopting new technologies.
Research and add new vendors to approved vendor list, lowering costs.
Introduce new processes including a semi-automated extraction process, reducing process time and personnel needed to conduct process from five people to one.

Hire, qualify, and evaluate the performance of lab technicians; resolve problems or issues with processes, procedures, and human relations concerns or communications.
Establish new systems including a new LIMS system for pain management and optimizing current LIMS system to auto-upload results and download test information to analyzer.
Created and validated LC/MS/MS methods for analyzing Benzodiazepines & Ketamine in Urine specimens.

Dr. Ruben Bonilla-Guerrero

MD. ABMG, ASCP. (Expert biochemical Genetics)

Dr. Ruben Bonilla-Guerrero, a Mayo Clinic trained laboratory medicine professional board certified in Clinical Biochemical Genetics by the American Board of Medical Genetics (ABMG) and in Molecular Biology by the American Society for Clinical Pathology (ASCP), with expertise in clinical pharmacology, inborn errors of metabolism, genetics, vaccine development, and clinical pharmacogenomics served as Laboratory Director, Associate Medical Director, and Medical Director of Medical Affairs of Genetics at Quest Diagnostics; Medical Director and Vice President of Medical Affairs at Admera Health; and Chief Medical Officer at Innovative Gx Laboratories. Currently, he is the Chief Executive and Medical Officer of Genetica Consulting.

Dr Pankaj Kumar

Ph.D (Respiratory Virology)

Dr. Pankaj Kumar, Ph.D., FADLM is a Clinical laboratory Immunologist and the Laboratory Co-Director of the high-complexity BC Neuroimmunology Laboratory, Vancouver and a Research Associate at the Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Dr. Kumar has wide-ranging expertise in Clinical and Diagnostics Immunology, Neuroimmunology and infectious diseases. Dr. Kumar’s research interests include the development, validation and implementation of the state of the art, precise, and accurate diagnostic tools for neurological and immunological disorders. He received speciality trainings in Autoimmune Encephalitis and Paraneoplastic Neurological Syndrome antibody testing with Prof Josep Dalmau at Hospital Clinic de Barcelona, Spain and with Professor Jérôme Honnorat at Hôpital neurologique, Lyon, France. He also received specialized trainings for CIDP antibody detection at Hospital Sant Pau, Barcelona and AQP4 and MOG-IgG at French National Reference Lab, Lyon. Dr. Kumar is the author of more than 40 peer-reviewed publications, book chapters, reviews and conference proceedings.

Joe Sebastian

Ph.D

Dr. Joe Sebastian serves as the Chief Executive Officer of Oraliva. He has more than 25 years of scientific leadership experience with extensive management roles in lab operations as applied to diagnostics and clinical trials. He has also served as associate VP &  Managing Director of the Molecular Oncology Lab at Labcorp. During his tenure at Labcorp, he also served as the National discipline director for Molecular infectious diseases. During this time, he was involved in the development and approval of several of the HPV, H1N1, HIV, HCV, and HBV diagnostic and treatment monitoring assays and oversaw the launch of several of these assays where the annual revenue was more than $120 million. He was instrumental in bringing HIV Genosure™, an HIV Genotyping assay as a standard of care (SOC) for assessing development of HIV drug resistance for patients who were treated with different classes of HIV drugs. 
 
Dr. Sebastian received his Ph.D. in Biochemistry from Washington State University and completed postdoctoral work at UNC- Chapel Hill and NIEHS/NIH at RTP, NC.  Dr. Sebastian has published 38 scientific publications in a variety of internationally renowned journals including PNAS along with 40 scientific poster presentations at national and international scientific conferences. He is a fellow of the National Academy of Clinical Chemists (AACC) and a member of the American Association of Molecular Pathology.

Abhishek Karnwal

 MD, MBA 

Dr. Karnwal, an Associate Professor of Anesthesiology at University of Southern California, also serves as an attending Anesthesiologist and Medical Director of Preoperative Services at Children’s Hospital Los Angeles.  
He has over a decade of clinical and research experience with an interest in outcomes and improving care for neurological divergent children, with numerous published articles and presentations in his field. He also enjoys long hikes, biking and wildlife photography.