FDA 510K clearance issued to BlueCheck, Incisive Technologies announces

Medical device company Incisive Technologies has announced that the US Food and Drug Administration (FDA) has issued 510K clearance for BlueCheck caries detection and monitoring, a novel caries detection device used by clinicians in dental examinations to aid the detection of early tooth decay. Early caries is the precursor to cavities and is recognised by the World Health Organization (WHO) as the world’s most prevalent chronic disease.

BlueCheck binds to active caries lesions and provides a visible blue, aiding dental professionals by providing a direct measure of disease

“By using the natural hydroxyapatite-binding chemistry of proteins the BlueCheck molecule targets porous surface and sub-surface lesions,” said Dr Jonathan Mangum, chief scientific officer and inventor of the technology. “It is a designed biomolecule, consisting of a protein, linker and dye, that selectively and reversibly binds to sites of dental demineralisation. BlueCheck is painted on, then a simple rinse washes away unbound BlueCheck, to reveal the active caries via the remaining bound blue,” he added. Due to the electrostatic interaction, removal of any bound BlueCheck is via brushing with toothpaste and interaction with saliva.

According to the US Centers for Disease Control and Prevention, dental caries affects more than 95% of Americans over their lifetime and leads to dental cavities, which require more invasive and costly restorations. “This decision represents a milestone towards ensuring that millions of people in the US, especially those in underserved communities, have access to oral health solutions with the potential to improve health outcomes. As one of the early investors in Incisive Technologies, we believe in the market opportunity here”, said Mariya Filipova, chief innovation officer, CareQuest innovation partners.

The WHO in their briefing on the prevention and treatment of dental caries recognised that minimally invasive intervention approaches avoid unnecessary pain, infection and permanent damage to teeth while preventing and treating caries. BlueCheck aims to support this by simplifying early caries detection.

“Dentists are notoriously bad at determining if enamel tooth decay is active or progressing, needing prevention and what part of the dentin is infected tooth decay, needing removal. Indicators that aid the dentist in finding active enamel and infected dentin are extremely useful,” said Prof Joel White, restorative dentistry, University of California.

In dental care, caries remains one of the most prevalent chronic diseases, even though it is largely preventable. Kerry Hegarty, CEO, Incisive Technologies said, “We saw that global experts and thought leaders are driving a shift to a prevention focus, whereby earlier detection of caries enables prevention medicaments to be used, halting the demineralisation process.

“However, finding dental caries early is challenging. The use of BlueCheck lets clinicians quickly and accurately supplement their evaluation, aiding the identification of early caries. Earlier diagnosis of dental caries is key to patient education, use of remineralisation therapies and ongoing monitoring for caries progression.”

She also said that the company has worked with dentists, orthodontists and research collaborators to understand how they can simplify the management of caries, support that shift to uplift care and improve patient outcomes.

BlueCheck is said to be the first product to be commercialised by Incisive Technologies. The group has research and collaboration projects to understand BlueCheck’s role in clinical management. The technology is also said to integrate with standard of care aiding clinicians to find demineralisation prior to cavities forming. BlueCheck will initially be launched in the US, with other markets to follow and will be available from September through US dental sales and distribution channels.