Sienna Lists First ASR Product With FDA

01-Jul-2014

In May 2014 Sienna Cancer Diagnostics announced the successful listing of its lead product, Anti-hTERT antibody (SCD-A7), with the US Food and Drug Administration (FDA) as an Analyte Specific Reagent (ASR).

Given the established power of the telomerase biomarker in correlating with malignancy, global pathology labs are interested in accessing this new reagent against telomerase to develop their own diagnostic tests. The registration of Sienna’s SCD-A7 reagent makes this a possibility. Sienna is in advanced discussions with major US pathology companies, with first sales expected later in the year.

Sienna’s Managing Director and CEO, Dr Kerry Hegarty said “US pathology labs will soon be the first in the world to be able to offer patients a urine test for telomerase developed using our product. Data from Sienna’s in-house clinical studies indicated potential benefits of SCD-A7 over other current testing procedures. Those results, combined with the non-invasive nature of the test, represent an important innovation, both for clinicians and patients.”

First FDA registered product manufactured under cGMP conditions