Strong Growth in Multiplex IVD and Steady Contribution from Technology Platform Partnerships
February 27, 2023 8:47 AM Eastern Standard Time
SANTA FE SPRINGS, Calif.–(BUSINESS WIRE)–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.
Top line growth came from increasing demands in Applied BioCodes’ multiplex IVD panels. The company’s FDA 510(k) cleared multiplex testing products Gastrointestinal Panel (GPP) and Respiratory Panel (RPP) full year sales displayed remarkable 57% and 94% growth year over year respectively. The company’s Q4 GPP and RPP quarterly sales show 20% and 323% growth year over year respectively, despite the decline in the overall IVD market due to the decreasing COVID testing demand.
The GPP and RPP tests are the company’s main syndromic testing products utilizing its proprietary platform technology, Barcoded Magnetic Beads (BMB), in conjunction with its FDA cleared high throughput molecular system BioCode® MDx-3000, can process 96 samples simultaneously across three different panels. Syndromic panels testing have become an important tool in clinical testing and patient care. They enable clinical microbiology laboratories to quickly identify bacteria, viruses, fungi, and parasites, which can help patients get the right treatment quickly. These tests can also cut down on unnecessary antibiotic prescribing when it won’t help patients and might contribute to antibiotic resistance. The company’s proprietary platform offers ‘masking’ option which enables users mask any of the targets up front so that only the desired targets are reported, increasing the flexibility to best fit the reimbursement requirement.
The company also sees steady growth in the other core business, the BMB partnerships, as full year BMB sales marks 15% growth YoY. Applied BioCode’s BMB technology combines microparticles with digital barcodes for multiplex immunoassays or molecular detection. The company has 4,096 unique barcodes that can be easily scanned and accurately identify biological targets.
“This, being my first, was a very strong and well rounded year for us. We saw a rapid rate of adoption with our GPP panel and solid numbers for our RPP and CoV-2 Flu Plus panels during Q3 and Q4. Not only did we replace all COVID revenue from 2021, our GPP and RPP businesses grew exponentially at 57% and 94% YoY, respectively. We are very excited about the launch of additional platform content in 2023 and continue to build and align the commercial team in anticipation of the release of these new panels,” said Chris Bernard, Chief Executive Officer.
Forward looking, the company aims to uptick the MDx-3000 installation in large molecular laboratories in US using a printer-cartridge business model, to continuously drive its IVD reagent business. The company pipeline also aims to add 2 new panel RUO panels to its content portfolio in 2023 and at least 2 more in 2024.
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 Beads (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® CoV-2 Flu Plus Assay ⱡ, 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.
ⱡ This product has not been FDA cleared or approved 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.
* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized 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 authorization is terminated or revoked sooner.
Chris Bernard, CEO