Genfit publishes new data on clinical performance of NIS2+ in older patients
The Fly

Genfit publishes new data on clinical performance of NIS2+ in older patients

Genfit announced the publication of new data on the clinical performance of NIS2+ in older patients, for the detection of at-risk nonalcoholic steatohepatitis, or NASH, in Hepatology Communications. In conjunction with Labcorp, a global leader of innovative and comprehensive laboratory services, data reported in the manuscript is the first to show and compare the clinical performance of NIS4(R) and its recently developed and improved upgrade NIS2+ in a population of older adults with well-established biomarker panels: FIB-4, NFS, ELF and ALT. While previously published data showed that NIS2+(TM) had a high overall clinical performance for the detection of at-risk NASH achieving an AUROC2 of 0.81 in a large study population, the Centers for Medicare & Medicaid Services, or CMS, in the US requires peer-reviewed, published data showing that tests, that will be used for patient management, have high assay performance in patients who are greater than or equal to65 years of age. Results of this study showed the clinical performance of NIS2+ was superior to other tests for the diagnosis of at-risk NASH in patients greater than or equal to65 years of age, greatly assisting with CMS reimbursement efforts. These data support the clinical value of this blood-based test for the diagnosis of at-risk NASH in older adults who would benefit from intensive lifestyle or therapeutic interventions.

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