Thyroid Study Initiated at RMH


Work on expanding the indications for Sienna’s hTERT test has resulted in a new study commencing.

  • Multiple sample types being sourced for a range of applications requiring internal R&D testing
  • Ethics Committee approval received to commence a proof-of-concept study at the Royal Melbourne Hospital (RMH) investigating the utility of Sienna’s hTERT IVD test in thyroid samples
  • Thyroid cancer has a significant unmet clinical need

Sienna is pleased to announce it has entered a clinical proof-of-concept study agreement with the Royal Melbourne Hospital (RMH), and received ethics approval to investigate the potential use of its hTERT In-Vitro Diagnostic (IVD) test on Fine Needle Aspirate (FNA) samples from the thyroid gland.

The IVD test detects hTERT, a core component of telomerase which is upregulated in approximately 85 per cent of tissue-based cancers, giving the test potential application in a range of cancer types.

Sienna is actively investigating several candidate applications in which its hTERT IVD test may add clinical value. Thyroid cancer is just one of several potential follow-on applications, selected in part for the significant unmet clinical need in this area, with an estimated 1.5 million thyroid cytology tests performed worldwide every year.

Dr. Julie Miller, Specialist Endocrine Surgeon and Chair of the Thyroid Cancer Multidisciplinary Team, RMH, said of the study: “Thyroid nodules are very common, but usually harmless. A needle biopsy can usually tell doctors if a nodule is benign or cancerous. However, approximately 10% of thyroid needle biopsies are reported as indeterminate and carry a 20-30% chance of harboring cancer. Patients with this diagnosis typically undergo surgery to remove half the thyroid to make the diagnosis.

“Sienna’s test may help resolve indeterminate needle biopsies limiting the number of patients that require surgical intervention. Our study will compare Sienna Diagnostics’ hTERT test on thyroid needle biopsies with matched thyroid nodules after removal. The goal is to see whether the test is accurate enough to make a correct diagnosis, and spare patients with thyroid nodules from unnecessary surgery.

If successful, this technique will represent a major breakthrough in care for patients with indeterminate thyroid nodules as patients with benign disease can avoid surgery altogether, while patients with cancer can have the correct operation the first time, rather than undergoing a two-stage procedure.”

Sienna Cancer Diagnostics CEO Matthew Hoskin said, “We are looking forward to commencing this proof-of-concept study which, if successful, would allow us to follow on with a more extensive thyroid clinical study, while in parallel continuing to research other opportunities to expand our hTERT market. Developing additional applications for our unique hTERT IVD test is one of four growth drivers being pursued for our business.”



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