NEW YORK (GenomeWeb News) – Silicon Valley molecular diagnostics firm IncellDx today said that it has achieved ISO 13485:2003 and ISO 9001:2008 certification.
Both certifications came with no deficiencies, the company said.
Based in Menlo Park, Calif., IncellDx's lead technology, called simultaneous ultrasensitive subpopulation staining/hybridization in situ, or SUSHI, is a method for getting the company's reagents into a cell in order to amplify signals. In January, the company announced it had raised $3 million in a Series A financing round to fund a clinical trial for its human papillomavirus test.
IncellDx today said that it will run clinical trials on the test this year followed by an application for FDA clearance.