The company’s in-vitro diagnostic (IVD) hTERT test help urologists to detect bladder cancer earlier.
Sienna’s primary platform is the detection of the biomarker telomerase, which is found in nearly all epithelial cancers, and was the subject of a Nobel Prize in 2009.
Telomerase is well recognised as a remarkable biomarker used by 85% of cancers to enable immortal cell replication.
Clinical validation completed by the customer
Following the signing of Biosystems Switzerland as the exclusive distributor for Switzerland of Sienna’s novel IVD test, the first order by a Swiss laboratory has been delivered.
This follows training of Biosystems key personnel by Sienna in late 2017, and evaluation and clinical validation by the customer.
A biomarker test for diagnosing bladder cancer
Although urine cytology is non-invasive, it has significant limitations in terms of sensitivity, particularly when it comes to low-grade or early-stage bladder cancer.
Having a biomarker test that can provide additional clinically significant information for the diagnosing physician, while using the same urine sample collected for cytology, adds real value to the diagnostic process.
Biosystems Switzerland has generated a pipeline of interested laboratories, several of which are well advanced in evaluating the test for clinical use.
Sienna listed on the ASX in 2017 following a successful initial public offer (IPO) which raised $4.6 million.
The company achieved significant milestones in 2017, including FDA registration of its IVD product in the U.S. and CE Mark approval and IVD registration in the Europe Union.
Sienna’s near-term objective is to maximise growth opportunities in the U.S., with significant interest already shown by pathology laboratories in the hTERT test.