hTERT ICC Test

Telomerase is recognised as an important biomarker in cancer. Approximately 85% of all human epithelial cancers up-regulate telomerase[1],[2]as a mechanism to avoid cellular senescence (death). The hTERT ICC Test is an antibody based immunocytochemistry stain that detects a component of telomerase. The initial commercial application of the hTERT test is as an adjunct to urine cytology, assisting in the diagnosis of bladder cancer by providing additional information to the testing already being undertaken. The test does not require dedicated equipment and the format in which it is provided allows it to be used on existing laboratory automated platforms. The hTERT Test has been registered with the FDA (USA regulatory authority), the Medicines and Healthcare products Regulatory Agency (MHRA – European regulatory authority) and the Therapeutic Goods Administration (TGA – Australian regulatory authority), for human clinical use.

There are approximately 1.5m urine cytology tests performed each year in the USA alone, the Medicare/Medicaid – CMS reimbursement of ~US$108 per test, hTERT is in a market valued at over US$160 million in the USA, in the application of
bladder cancer alone. The USA represents approximately 25% of the global IVD test volume, it is estimated there are a further ~4.5m urine cytology tests performed in the rest-of-world resulting in a market opportunity of ~6m tests on the application of bladder cancer alone.

Data and Results

In a 2018 study of 500 patients undertaken at Johns Hopkins and published in Acta Cytologica the hTERT test demonstrated negative predictive value of 85%. The study concluded that a positive hTERT result may identify a subset of patients with an increased risk of high-grade Urinary Tract Carcinoma (HGUC) who may otherwise not be closely followed, while a negative hTERT immunocytochemistry result is associated with a reduction in risk for HGUC.

In a follow up publication titled “The hTERT ICC Test as an Adjunct to Urine Cytology: A Longitudinal Follow-Up” hTERT was detected in 94 patients that were clinically negative for Urothelial Cell Carcinoma (UCC) at the time of testing. Upon follow-up 23/94 (25%) patients were found to have a malignancy. Of these 23 patients, 16 were confirmed to have UCC by rigid cystoscopy and biopsy, 4 were confirmed as upper urinary tract malignancies. The performance of the hTERT test in detecting UCC post follow-up demonstrated a significant improvement with a sensitivity and specificity of 88% and 57% respectively with an NPV of 96%.

[1]Chen, C-H and Chen, R-J (2011) Prevalence of telomerase activity in human cancer J Formos Med Assoc

110 (5):275-289.

[2] Kim, NW (1997) Clinical implications of telomerase in cancer European J Cancer 33(5): 781-786.