The device, named the Verisante Aura, uses Raman spectroscopy to measure levels of various biomarkers – including proteins, nucleic acids, and metabolites – in skin lesions. In initial clinical trials it distinguished between benign and malignant lesions with 100-percent sensitivity and 70-percent specificity.
According to the company's earnings statement, MDxHealth's product and service revenues nearly doubled – from €1 million in 2009 to €2 million in 2010 – due to several companion diagnostics deals and biomarker licensing agreements inked with major drug companies.
The device, which the scientists are developing under a two-year, €1.3 million grant from Germany's Federal Ministry of Education and Research, uses cytometric bead arrays to quantitate protein biomarkers in patients' exhaled breath condensate.
The diagnostic is being developed using a new peptoid-based technique for detecting disease-specific antibodies that could prove broadly useful as a protein biomarker discovery tool, said a researcher.
The test is intended both for early screening purposes and the differential diagnoses of lung nodules detected during CT scans and x-rays. SomaLogic has partnered with Quest Diagnostics to commercialize the test, with a lab-developed version slated for launch next year.