Justin Petrone covers consumer genomics, ancestry testing, and the microarray and biochip sector of the genomics market for GenomeWeb.
The company in partnership with the University of Edinburgh recently completed a trial of the test involving 400 patients.
The number of technologies to be assessed is vast, and ranges from liquid biopsies and molecular imaging to immunohistochemistry and RNA-seq.
If the UK leaves the EU on Oct. 31 without a deal, the Medicines and Healthcare Products Regulatory Agency will start regulating medical devices and IVDs.
With the significant overhaul of the European regulatory landscape underway, some fear it may disproportionately affect small and medium-sized IVD companies.
The pilot study with the Mayo Clinic is the final step before SkylineDx commences a US trial next year for its molecular test for primary cutaneous melanoma.
The company's goal is to serve what it sees as a massive but underaddressed target group: Asian women.
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.