NEW YORK — Precipio said on Tuesday that it has received CE-IVD marking for reagents used in its HemeScreen panels for hematologic malignancies.
They include HemeScreen MPN for myeloproliferative disorder, HemeScreen AML for acute myeloid leukemia, HemeScreen Anemia/MDS for anemia of unknown cause and myelodysplastic malignancies, and HemeScreen CLL for chronic lymphocytic leukemia.
The HemeScreen assays screen for mutations in specific genes and rely on PCR amplification followed by High Resolution Melt analysis.
The company said it can now market the panels in the 27 countries of the European Union and the UK.
"While we remain focused on growing our business in the US, broadening our customer base by entering new markets will provide additional growth opportunities and revenue diversification," Precipio CEO Ilan Danieli said in a statement.
Precipio said that it intends to market the HemeScreen products in Europe through distribution partners, following its US commercialization strategy.
In late 2021, the New Haven, Connecticut-based company received New York State approval for HemeScreen MPN.