A look at Sienna’s innovative IVD technology for enhanced bladder cancer detection


Australian bio-tech player, Sienna Cancer Diagnostics Limited (ASX: SDX) has developed novel diagnostic technologies that can detect the likelihood of bladder cancer being present in patients. It provides valuable information to the pathology laboratories with respect to increased risk of cancer in patients which may go undetected by urine cytology alone.

Biotechnology pioneer Sienna recently launched the first-ever in-vitro diagnostic (IVD) product for the detection of the biomarker telomerase. It is called Anti-hTERT antibody or SCD-A7 that detects human Telomerase Reverse Transcriptase (hTERT), a catalytic subunit of the enzyme telomerase, in urothelial cells. 

The company has stated that product is CE marked and has already been listed with Australian Register of Therapeutic Goods (ARTG) as well as with the Food and Drug Administration (FDA) for sales in the United States.

Recently, Sienna expanded its global footprints through the appointment of new Singapore-based distribution partner Mediwell. The company has eyed fast-growing market for its in-vitro diagnostic tests in the Singapore market of 5.8 million people which adds to its presence in the Asian market.

The development of the product comes after the positive outcome of the study conducted by Johns Hopkins Hospital. The study has concluded that the use of hTERT immunocytochemistry (ICC) tests as an adjunct to urine cytology provides useful clinical information to the pathologist about the presence of cancer cells in the patients’ urinary system. That means the company’s new IVD product is currently being used as a supplementary test to the standard non-invasive test performed on urine samples examined for the presence of cancerous cells.

Moreover, the study reportedly revealed that the addition of the hTERT test to urine cytology increased the sensitivity to 52% in the identification of urothelial cancer compared to 31% sensitivity detected under conventional urine cytology alone.

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Sienna led by Chief Executive Officer Matthew Hoskin, believes that its IVD hTERT test may be an early indicator that a low or even a high-grade cancer is present, or that one may be developing even if other tests are negative for bladder cancer.

That means the patients who are diagnosed as negative for high-grade cancerous cell (urothelial carcinoma) by cytology may be spotted positive for the likelihood of cancer in a bladder and confirmed by biopsy to have a low-grade urothelial carcinoma. Even the test is expected to improve the detection of early-stage lesions not well detected by urinary tract cystoscopy.

The company has been working on the commercialization of its IVD hTERT test product at a very rapid pace. As discussed above, in the first week of February, Sienna inked a non-exclusive distribution agreement with Mediwell Enterprise Pte. Ltd, a supplier of medical equipment and related diagnostics supplies, following the appointment of an exclusive distributor for mainland China in 2018 and South Korea in January 2019.

Mediwell Managing Director Mr Y.K. Cheng stated: “Mediwell has already received positive responses for Sienna IVD products from local IHC technology laboratories and is in talks with local hospitals for evaluation of the test, with a plan for those hospitals to serve as the initial entry points for the test in Singapore.”

SDX last traded at $0.064 on 6 February 2019 with a positive price change of 6.67% over the past one month.


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