Precipio Receives a CE-IVD Mark for its HemeScreen Diagnostic Reagents

Specialty cancer diagnostics company Precipio has received a CE-IVD mark for its HemeScreen reagents used in cancer-diagnosing test panels.

The reagents are approved for myeloproliferative neoplasms, acute myeloid leukemia, anemia/myelodysplastic syndromes and chronic lymphocytic leukemia. Together, those account for more than 70 percent of hematologic malignancies, the New Haven, Conn.-based company said.

Precipio CEO Ilan Danieli said the company will replicate its U.S. commercialization strategy of partnering with distributors in Europe and other markets that accept the CE-IVD mark.