DiaSorin said Tuesday that it has secured CE marking for an immunodiagnostic assay to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections, and the firm is launching the assay in Europe.

Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML).

MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).

BGI Genomics said on Friday that its multiplexed test for SARS-CoV-2, influenza A, and influenza B is now included in the Australian Register of Therapeutic Goods.

DiaSorin said on Friday that its second quarter revenues rose 20 percent year over year, driven by strength in molecular diagnostic test sales.

Agilent Technologies on Tuesday announced that it has received CE marking for the expanded use of its PD-L1 IHC 22C3 pharmDx companion diagnostic assay in patients with non-small cell lung cancer.

Xiamen Spacegen, a provider of oncology molecular diagnostics products and services in China, said recentlythat it hadreceived CE marking for six testing kits. These kits include a human thyroid carcinoma RET gene fusions detection kit, whic

Xiamen Spacegen, a provider of oncology molecular diagnostics products and services in China, said recentlythat it hadreceived CE marking for six testing kits. These kits include a human thyroid carcinoma RET gene fusions detection kit, whic

Xiamen Spacegen, a provider of oncology molecular diagnostics products and services in China, said recently that it had received CE marking for six testing kits. These kits include a human thyroid carcinoma RET gene fusions detection kit, wh