SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced today that Chris Bernard has been appointed as their new Chief Executive Officer (CEO). Mr. Bernard joins as Applied BioCode continues to expand its US commercial footprint and explores US & global expansion and new opportunities for their technology. With its current portfolio of PCR-based, multiplex molecular diagnostic tests in the respiratory and gastrointestinal markets, along with the new SARS-CoV-2 Flu Plus Assay EUA approval, the company is continuing to scale its commercial business in providing transformative solutions for high throughput molecular diagnostics.
Chris Bernard brings 27 years of strong commercial, operational, and R&D leadership experience in diagnostics and medical devices to Applied BioCode. Most recently Chris was CEO of Oncogenesis Inc., a startup in oncology diagnostics, and Curetis USA Inc., (Opgen Inc.), a multiplex, infectious disease diagnostic company. He also has held various commercial executive roles at Epic Sciences Inc., Metabolon Inc., Abaxis Inc. (Zoetis Inc.), and Cytyc Corp (Hologic Inc.). His extensive experience will be key in evaluating current and emerging opportunities as the company enters its next phase of commercial expansion.
“The Applied BioCode team has developed a really innovative, multiplex PCR-based technology and the platform is uniquely positioned in the marketplace,” said Mr. Bernard. “I look forward to leading the company into our next phase of growth and long-term success. I am also excited to collaborate with Dr. Winston Ho, President, and the Board of Directors as we execute on the vision of delivering a cost-effective diagnostic platform that is designed to optimize workflow and alleviate pain points for mid to high throughput PCR labs.”
“Applied BioCode was founded to develop digital multiplex technology, broaden access, increase efficiencies, and reduce the cost of diagnostic testing,” explained Dr. Ho. He added, “As a scientist by training, my passion lies in forging the technology and innovation that will allow Applied BioCode to grow based on a very solid body of knowledge. Chris has an outstanding background and I’m confident his addition to the team will propel us forward to an even brighter future.”
Board Chairman, George J. Lee, Ph.D., commented, “With his fresh perspective and leadership, Chris will work closely with Dr. Ho to deliver on the company’s global strategy and mission as a molecular diagnostics company, through product development, commercialization, and strategic alliances.”
To learn more about the Applied BioCode team and offerings, visit: https://apbiocode.com/products.htm
About Applied BioCode
Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products. The company has combined "digital barcodes" with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Bead (BMB) Technology. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets. The company has FDA 510(k) clearances for their 17-plex Respiratory Pathogen Panel (RPP) and 17-plex Gastrointestinal Pathogen Panel (GPP) based on their BioCode® MDx-3000 automated system. The GPP and RPP are CE-Marked for use in European countries conforming to CE-Mark regulations. Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay**, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*. Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.
* The BioCode® SARS-CoV-2 test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by licensed laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
** The BioCode® SARS-CoV-2 Flu Plus test has not been FDA cleared but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B, and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
