Justin Petrone covers consumer genomics, ancestry testing, and the microarray and biochip sector of the genomics market for GenomeWeb.
The test is the cornerstone of a study involving roughly a thousand patients from two British neonatal centers that is set to commence this fall.
Representatives of NBs said they are adding capacity to allow oversight of the anticipated wave of submissions before the new IVD Regulation comes into force in three years.
The lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer.
While results are preliminary, the test could potentially be used in lieu of a liver biopsy.
The partners believe their technology could have advantages over others used in early-stage cancer detection, such as next-generation sequencing.
The firm is working with a new center in Dakar, Senegal, that will deploy new tests based on the platform to support early detection of tropical diseases.
The test relies on a signature that Almac developed for stratifying breast cancer patients, but which, as the researchers showed, can be used in other cancers as well.
VALUE-Dx involves six IVD companies and is being heralded by participants as an opportunity for competitors to work together to improve test adoption.
CEO Yoel Ezra said the firm plans to deploy a prototype in pilot studies next year, and is eyeing opportunities in the US, Europe, India, and the Middle East.
For the Evry, France-based company, the grant will support its vision of making its technology available as a platform for running oncology assays.