SkylineDx Receives CE-IVD Mark for Its Merlin Assay

Molecular diagnostics company SkylineDx’s Merlin assay for melanoma has received Europe’s CE-IVD mark.

The Merlin assay can identify melanoma patients who have a low risk for metastasis and who can safely forgo an invasive lymph node biopsy surgery. In approximately 80 percent of surgeries, the biopsy comes back negative for metastasis, the company noted.

The assay runs on standard quantitative polymerase chain reaction (qPCR) equipment found in most laboratories.

Netherlands-based SkylineDx, which also has offices in San Diego, Calif., said it is launching the Merlin assay in Europe this month.