Close Menu

FDA submission

The company's platform and assay use fluorescent lateral flow technology to detect Helicobacter pylori antigens in human stool samples.

The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.

The firm said it anticipates launching the platform in Europe next year and completing its first round of external financing in the first quarter of 2020.

Unlike existing methods for sepsis diagnosis, which rely on the use of a single marker, Mologic's technology is based on six undisclosed markers.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.

The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.

The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.

The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates to help guide treatment decisions.

The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.

Pages