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Applied BioCode Submits MDx Platform, GI Panel for 510(k) Clearance

NEW YORK (GenomeWeb) – Applied BioCode has submitted a high-volume molecular testing platform and a gastrointestinal panel to the US Food and Drug Administration for 510(k) clearance following recently completed clinical trials, the company announced today.

The firm intends its BioCode MDx-3000 automated PCR-based molecular diagnostic testing system to be used in large hospitals and reference labs.

The Gastrointestinal Pathogen Panel (GPP) tests for nucleic acids of 18 common bacteria, viruses, and parasites that cause infectious diarrhea, and is the first of a many syndromic multiplex panels the firm expects to commercialize on the MDx-3000 system, according to a statement. 

Applied BioCode has previously noted that it expects the GPP assay to compete in the market with the xTAG GPP panel from Luminex, and the firm believes it's system, which has been in development for a number of years, will have an advantage over Luminex's non-automated system. Luminex recently halted clinical trials for an automated multiplex instrument being developed for infectious disease testing citing issues around cassette failure rates and test reimbursement uncertainty.

"Feedback from our US clinical trial sites has been extremely positive and reinforces the need for a more automated high-throughput multiplex molecular test system," Applied BioCode President Winston Ho said, adding that clinical trial sites noted the ease-of-use of the BioCode system and the ability to quickly train their staff to use the platform.

The firm's core technology enables coupling up to 4,096 unique digital barcodes on magnetic beads to DNA or protein targets, while the MDx-3000 provides automated amplification, hybridization and target capture, and detection steps for molecular tests. The MDx-3000 system also offers target masking capabilities within panels to address variation in test ordering patterns and potential changes in panel reimbursement, the firm said. 

Pending FDA clearance, Applied BioCode anticipates commercial release of the BioCode MDx-3000 with the GPP test in the first half of 2018. Future products will focus on molecular infectious disease testing, including respiratory and sexually transmitted infections. 

Applied BioCode has also partnered with other diagnostic companies on applications that include infectious diseases, autoimmune diseases, allergies, transplantations, transfusions, hepatitis, and the gut microbiome, the firm noted, and has partnering and licensing agreements with Diatherix, PerkinElmer, Hologic, Genetic Analysis, and Douglas Scientific.