FDA Registration For Sienna - First IVD Product Listing

15-Nov-2016 Sienna Cancer Diagnostics has listed an in-vitro diagnostic (IVD) medical device with the United States Food & Drug Administration (FDA), achieving the final regulatory step in the commercialisation of a clinical test for the cancer biomarker telomerase.

Sienna’s IVD product will be made available to pathology laboratories throughout the USA via distribution partner StatLab Medical Products.  The product enables pathology laboratories to detect the presence of telomerase in cells found within cytological samples.  The test has been developed to work using immunocytochemistry (ICC), which allows pathologists to visualise exactly which cells have stained positive for the presence of telomerase.

An important initial application of the IVD will be its use as an adjunct to routine urine cytology testing.  The test will provide additional information that pathologists can use as part of their diagnostic assessment of bladder cancer.  A large number (Sienna estimates ~1.5M) of urine cytology tests are performed every year in the USA, creating a sizable market for Sienna’s telomerase IVD.


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