Mr. Davis joined Akonni Biosystems April 2007 as Director of Operations. He was promoted to Vice President of Operations in 2008 and appointed Corporate Secretary in 2013. In 2016, he was appointed co-sponsor for Akonni’s medical device development project, the TruDiagnosis System / Warfarin Sensitivity Test. In that role, he led Akonni’s multidisciplinary team and he was project lead for the TruDx Imager hardware and software design. In addition, he managed clinical lab operations for Akonni and oversaw the manufacturing of instruments and consumables for investigational use. Prior to joining Akonni, Mr. Davis served as Department and Technical Manager for General Dynamics’ Chemical Biological Radionuclide (CBRN) business unit. He served in similar roles and as operations manager and microbiologist with Veridian Corp and Pacific Sierra Research, where he worked with multidisciplinary teams to develop novel biological detection technologies for U.S. Defense and Homeland Security customers. He also served as a technical lead for field trials of integrated biological collection and detection systems at Edgewood Chemical Biological Center. Mr. Davis has over 30 years of general management experience and 20 years of product development experience in integrated biosensors encompassing a broad range of disciplines including chemistry, biology, biomaterials, engineering, and chemical/biological defense. He manages and leads multidisciplinary teams of scientists and engineers focused on the development of next-generation in-vitro diagnostic devices. In addition, he has commercial senior management experience (P&L responsibility) from 447 Corp and Akonni. As the Acting President of Akonni Mr. Davis is responsible for 1) setting and executing strategic direction, 2) product management, 3) managing capital, financial audits, 4) corporate governance, shareholder relations, 5) leading business development, strategic partnerships, 6) recruiting, mentoring, listening and learning from Akonni’s exceptional staff, and 7) continuing the excellence of Akonni’s company’s culture. Mr. Davis holds a B.A. in Biology from the University of Virginia.
As Director of Engineering at Akonni Biosystems, Dr. Cooney leads an innovative multi-disciplinary team of engineers and scientists in the pursuit of affordable, highly-informative diagnostics. Dr. Cooney draws upon more than 15 years of multi-disciplinary microfluidics and bioinstrumentation experience from both academia and industry – four years in post-graduate academia and more than ten years in industry. Prior to serving as Director of Engineering at Akonni Biosystems, Dr. Cooney was an Engineering Manager at Northrop Grumman’s R&D Division and served as a technical liaison with the Manufacturing Division for the deployed Biohazard Detection System. There he also led the R&D of a microfluidic cartridge for isothermal assays for biodefense applications. One of these isothermal assays (Ionian NEAR assay) became the first CLIA-waved molecular diagnostic (Alere-i product line). Prior to his work at Northrop Grumman, Dr. Cooney investigated digital microfluidics applied to isothermal molecular assays, and he co-developed a patented low-cost isothermal fluorescence reader as a scientist at Keck Graduate Institute. Prior to this position, Dr. Cooney served as Research Director for Biomechanics Research and Associates where he was responsible for developing customized analysis instrumentation. Dr. Cooney is named on numerous publications, patents and grants. As principal investigator of projects, funded by the National Science Foundation and the National Institutes of Health, he oversees both the development of high-confidence Lab-on-a-FilmTM diagnostic tests using the same low-cost reel-to-reel manufacturing methodologies as used for pregnancy tests and the development of point-of-care diagnostics to detect drug resistance in low resource settings.
Dr. Holmberg joined Akonni Biosystems in 2008 and currently leads the commercialization effort for Akonni’s sample preparation product line including the TruTip Automated Workstation, on track to be a FDA Class I device, and Purification Kits covering a wide range of clinical applications. As a certified, experienced Project Management Professional, she manages multidisciplinary teams, comprised of both internal and external stakeholders, towards the development, verification and validation of our products following Design Control. In addition, Dr. Holmberg made significant assay and method development contributions to Akonni’s test-menu pipeline. Prior to Akonni, Dr. Holmberg was a Senior Scientist at Ionian Technologies where she developed molecular assays for rapid detection of biowarfare agents and genetically modified foods. She is a co-inventor of NEAR, Ionian’s patented isothermal amplification technology which became the first CLIA-waived molecular test in 2015 under the Alere-i product name. Over the course of her career in industry she has served as PI, Co-investigator, or Key Personnel to lead assay development projects on grants, contracts, and programs under federal agencies including NIH, NIJ, DARPA and DTRA. She received her Ph.D. in Inorganic Chemistry from the University of North Carolina, Chapel Hill researching metal-mediated redox detection of DNA, after which she studied polymerase evolution and recognition of unnatural nucleobases as an NIH Postdoctoral Fellow at The Scripps Research Institute in La Jolla, CA. Dr. Holmberg is author on a number of peer-reviewed scientific publications, and co-inventor on multiple issued or pending US and worldwide patents.
TruDiagnosis Systems, TruDx Readers, TruArray Tests, TruTip Kits, Primers, Lysis and Binding Buffers, Wash Buffers and Elution Buffers: For Research Use Only. Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention or treatment of a disease.