Bostwick Laboratories to Use Sienna Reagent in World-First Telomerase Stain for Bladder Cancer Launched Today

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Bostwick Laboratories, the USA’s leading uropathology laboratory has announced a commercial agreement with the Australian group, Sienna Cancer Diagnostics (Melbourne), under which access to a new cancer detecting antibody, SCD-A7, is secured. Bostwick Laboratories’ lab developed test, which includes the telomerase stain for bladder cancer, CytologyPro XT will be launched today.

Bostwick Laboratories, the USA’s leading uropathology laboratory has announced a commercial agreement with the Australian group, Sienna Cancer Diagnostics (Melbourne), under which access to a new cancer detecting antibody, SCD-A7, is secured. Bostwick Laboratories’ lab developed test, which includes the telomerase stain for bladder cancer, CytologyPro XT will be launched today.

-Bostwick Laboratories Inc. will be the first to deploy the new Anti-hTERT antibody (SCD-A7) from Australian in vitro diagnostic provider, Sienna Cancer Diagnostics.
-The agreement marks the first clinical application of the innovative telomerase technology in the world.
-Clinical staining of SCD-A7 has shown that it may offer greater accuracy than existing bladder cancer cytology tests and could significantly reduce the number of problematic “indeterminate” cytology results, thereby avoiding unnecessary procedures or missed diagnoses, leading to better patient outcomes and healthcare cost savings.

The new partnership signals the first clinical application of Sienna’s innovative, telomerase-detecting Anti-hTERT antibody (SCD-A7) in bladder cancer. The agreement, which follows registration of Sienna’s reagent with the US Food and Drug Administration (FDA) in June 2014, will see Bostwick Laboratories apply SCD-A7 to its own suite of urinary diagnostic tests where it will be used to detect telomerase, an established biomarker for a range of cancer types.

Bladder cancer is the fifth most common cancer in the United States, with more than 72,000 cases diagnosed in 2013. In 2014, the number of new cases of bladder cancer rose to over 74,500.

Bostwick founder Dr. David Bostwick said, “Bostwick Laboratories is excited to be the first uropathology service provider in the world to offer a telomerase-based diagnostic stain for bladder cancer diagnosis. CytologyPro XT is truly state of the art, exploiting the power of telomerase in the clinic for the first time.”

“This new offering will greatly add to the range of stains and services we currently offer our physician clients and their patients. Tests created using this Sienna reagent have the potential to strongly complement existing cytology methods by resolving indeterminate results and possibly identifying disease at an earlier stage,” said Dr. Bostwick.

Sienna’s CEO Dr Kerry Hegarty said, “Today marks a huge milestone for Sienna. Bostwick Laboratories is an ideal first partner for the use of SCD-A7 in bladder cancer. Bostwick Laboratories will now use the Sienna reagent in a unique stain assisting with indeterminate results in urine cytology – a much welcomed solution by cytopathologists globally. Bostwick Laboratories’ investment in developing a novel lab test with our reagent is yet another example of their relentless pursuit of innovation, and we are delighted to be initiating sales of our first commercial product with such a leading organization.”

The work to develop and launch CytologyPro XT follows the introduction of several other valuable additions to the Bostwick menu in the past year, primarily related to the stratification and detection of prostate cancer. With decades of dedication to offering technologically advanced testing to ensure greater accuracy and efficiencies, Bostwick Laboratories is assured to maintain its reputation amongst US clinicians as the laboratory of choice for primary and secondary opinions.

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About Bostwick Laboratories
Bostwick Laboratories provides anatomic pathology laboratory services specializing in the monitoring and diagnosis of cancer. Bostwick Laboratories is a leader in urologic pathology with expertise and a growing presence in the women’s health, dermatology, gastroenterology and nephrology sectors of the anatomic pathology market. Bostwick Laboratories and its staff of board-certified, internationally recognized pathologists provide definitive diagnoses and the most technologically advanced testing available to help physicians and patients choose the best course of treatment.

About Sienna Cancer Diagnostics
Established in 2002, Sienna Cancer Diagnostics Limited is an unlisted public biotechnology company, specialising in the development of novel reagents and diagnostic stains for cancer using telomerase, an important biomarker in many types of cancer. Telomerase is an enzyme that elongates chromosome ends (“telomeres”) and can be found in 80-90% of human carcinomas and circulating cancer cells. The telomerase platform drives Sienna’s pipeline and underpins the establishment of key partnering opportunities worldwide.

About anti-hTERT antibody (SCD-A7)
Sienna’s anti-hTERT antibody (SCD-A7) can be used in lab developed diagnostic tests to detect telomerase. Registration of SCD-A7 with the US Food and Drug Administration (FDA) as an Analyte Specific Reagent (ASR) followed cGMP manufacturing and compliance with the FDA’s Quality Systems Regulations. FDA registration enables Sienna to supply SCD-A7 to US-based pathology companies for use in urine-based in vitro diagnostic stains to detect bladder cancer.

About Telomerase and Bladder Cancer
Telomerase is a naturally-occurring enzyme expressed in some replicating human cells and malignant tumours, including bladder cancer. It is widely regarded as having potential in both therapeutic and diagnostic applications. In 2009, the Nobel Prize in Physiology / Medicine was awarded for the discovery of telomerase to three co-workers, including Australian Elizabeth Blackburn. Unlike many potential cancer biomarkers in development, telomerase is well-established in the scientific literature as associated with ~90% of human cancers, signifying its key role in cancer development.

Bladder cancer is the fifth most common cancer in the USA, and the first in terms of total medical care cost per patient due to its propensity to re-occur after diathermy or resection of lesions from the bladder wall. Over 70,000 individuals are diagnosed with bladder cancer annually in the USA and more than 530,000 people in the USA live with a history of bladder cancer, thus requiring regular diagnostic monitoring. It is estimated that more than one million cytology tests are conducted annually in the USA for initial diagnosis and ongoing monitoring of bladder cancer patients. The gold-standard (invasive) test for diagnosis (called a cystoscopy) can cost up to $2,000 per procedure. Simple, cost-effective, non-invasive urine tests using the Sienna reagent are expected to assist in the early detection of cancer and are in line with rapidly evolving changes in global health care policies.

Forward Looking Statements
This document contains statements relating to Sienna’s future revenue stream and product development that may constitute forward-looking statements. These statements may be identified by words such as “potentially”, “will”, “looking to”, “vision”, “goal”, “could be”, “intends”, “expected”, “estimates”, “ideally” or words of similar meaning. Sienna may also make forward-looking statements in other press releases or documentation including both written and oral statements. Any such statements are based on Sienna’s current expectations and are, therefore, subject to known and unknown risks and uncertainties. A variety of factors, many of which are beyond Sienna’s control, affect Sienna’s performance, achievements, results and product development and could cause the actual performance, achievements, results and product development of Sienna to be materially different from any future performance, achievements, results and product development that may be expressed or implied by any such forward-looking statements. No representation or warranty, express or implied, is made by Sienna that any forward-looking statements contained in this document will be achieved as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on any statements in this document which may constitute forward-looking statements.

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Brent Sower

Kerry Hegarty