Articles from Applied BioCode

Applied BioCode, a leader in innovative molecular diagnostic solutions, announced today the submission of a new nucleic acid extraction claim for the KingFisher™ Flex Nucleic Acid Purification System in combination with the BioCode® Respiratory Pathogen Panel (RPP). This submission is aimed at expanding the use of the BioCode® RPP, enabling laboratories to further streamline workflows while maintaining high-quality, reliable results.

Applied BioCode announced today that Beth Laderman has been appointed as their new Chief Scientific Officer (CSO) signaling a significant step in the company’s expansion. With 25 years of experience in the medical diagnostic field, Dr. Laderman brings expertise from her previous roles at HYCOR Biomedical and Biomerica Inc. Her appointment is set to drive Applied BioCode’s focus on expanding its MDx-3000 platform and exploring new applications for its patented barcoded magnetic beads (BMBs). Dr. Laderman 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 assays in the respiratory and gastrointestinal markets, along with the new BioCode Fungal Panel RUO approval, the company remains steadfast in its mission in having R&D fully support the commercial enterprise by delivering transformative solutions for high-throughput diagnostics.

Applied BioCode now offers Fungal Panel on the BioCode® MDx-3000 system for research use only (RUO).

Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu. The MDx-3000 menu consists of products that enable the diagnosis of upper respiratory infections and gastrointestinal infections, as well as a suite of Analyte Specific Reagents (ASRs), which high-complexity laboratories can use to develop their own laboratory developed tests (LDTs).

Applied BioCode announced today its 2022 revenue $13MM, which marks 13% growth year over year, hitting the company’s historic high. Q4 revenue was just shy of $4MM representing 9% growth quarter over quarter.

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.

Applied BioCode today announced an agreement with Hardy Diagnostics, a leader in manufactured and distributed microbiology products in the United States, for the distribution of the MDx-3000 System and its comprehensive menu for the diagnosis of upper respiratory infections, gastrointestinal infections as well as a suite of Analyte Specific Reagents (ASRs) which can be used by high-complexity laboratories to develop their own laboratory developed tests (LDTs). Under the terms of the exclusive agreement, Hardy Diagnostics will begin offering the MDx-3000 System to clinical laboratory customers in the United States.

Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode® CoV-2 Flu Plus Assay. This PCR-based, multiplex molecular diagnostic assay can simultaneously detect and differentiate between SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3, Influenza B), and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens. The test is designed to assist physicians in evaluating patients with clinical signs and symptoms respiratory infection.

Applied BioCode announced today that it has released 28 Fungal Analyte Specific Reagents (ASRs) for use in molecular tests. (15 ASRs for mold pathogens, 10 ASRs for yeast pathogens, and 3 ASRs to detect dimorphic fungi). These ASR products utilize the company’s proprietary Barcoded Magnetic Bead (BMB) technology for specific detection of targeted organisms.