Applied BioCode (ABC-KY) is leveraging three key growth drivers this year—digital barcodes, multiplex in vitro diagnostic (IVD) assays, and large-scale laboratory partnerships. The company aims to achieve break-even and emerge from losses by the end of this fiscal year. Looking ahead, its new multiplex urinary tract infection (UTI) assay is expected to enter clinical trials next year, providing fresh momentum for its operations.
This flu season has seen a global surge in outpatient visits, with multiple strains of influenza and other viruses circulating simultaneously. As a result, Applied BioCode’s 20-panel multiplex respiratory pathogen assay has experienced a significant increase in shipments, driving February revenue up by 75.26% year-over-year. Currently, revenue is evenly split between its digital barcode technology (BMB) and multiplex diagnostic reagents (IVD). However, the company expects IVD's share to rise to 60% this year, which will positively impact profitability given its higher gross margins.
In January, Applied BioCode received U.S. FDA clearance to market its MDx 3000 system, paired with the nation’s most widely used nucleic acid extraction instrument. Due to growing testing demands, some laboratory customers have opted to purchase the MDx 3000 instead of leasing it. Three major national laboratory groups in the U.S. have already installed the MDx 3000 and are progressing through their validation processes. Last year, Applied BioCode secured a record number of new customers, and shipments to these clients are expected to begin this year, further contributing to operational growth.
Orders for Applied BioCode’s digital barcode technology continue to grow steadily. The company has licensed the technology to several major global biotech firms, including Idexx, a leader in veterinary diagnostics, and China’s prominent autoimmune diagnostics company, Livzon Diagnostics. Applied BioCode has also successfully entered several national flagship hospitals. Its current order backlog stands at US$1 million, with sustained growth expected.
Applied BioCode’s other infectious disease diagnostic product lines include its proprietary multiplex fungal detection panel and its STI+AMR assay, which combines sexually transmitted infection detection with antimicrobial resistance gene testing. These assays, along with the in-development UTI assay, are all compatible with the MDx 3000 automated diagnostic system. The UTI assay is slated to enter clinical trials next year, with patient enrollment expected to be completed within two quarters.
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