The hTERT ICC assay is an immunocytochemistry test that is used as an adjunct to urine cytology.

The product, Anti-hTERT antibody (SCD-A7) is:

  • An antibody targeted against the hTERT, the protein component of the telomerase complex
  • Listed with the FDA as a Class I medical device in the USA, with existing reimbursement in that market

Telomerase is well recognised biomarker used by 85% of epithelial cancers to enable immortal cell replication. This occurs through the enzymatic role telomerase plays in the repair of chromosome ends known as telomeres. Ordinarily, cell telomeres shorten with each successive cell division until the cell dies, a process called senescence. Telomerase counteracts this telomere shortening process by adding new telomeric repeat sequences, effectively repairing the end of the telomere.

The discovery of telomerase and its role in cellular immortality resulted in a Nobel Prize for Elizabeth Blackburn PhD and her colleagues.                  Link to press release

Translating telomerase into a biomarker of clinical activity is complex. The telomerase enzyme comprises:

  • An RNA component (hTR), which acts as a template for DNA replication,
  • The telomerase reverse transcriptase (hTERT), which is responsible for catalytic activity
  • Accessory proteins, including dyskerin.

Of the various telomerase components, the Company has found assaying for hTERT is the most practical and efficient way of detecting the complex telomerase enzyme in a clinical setting.

Download Safety Data Sheet (SDS) for the IVD product here.

The hTERT test is currently being used as an adjunct to urine cytology testing, the standard non-invasive test performed on urine samples being examined for the presence of cancerous cells (bladder cancer). Now an additional slide upon which the hTERT test has been performed, may be examined by a pathologist to determine if hTERT has been detected in the nucleus of urothelial cells shed from the bladder wall.

“Testing urothelial cells for the presence of hTERT is a great improvement over urine cytology alone. The presence of this biomarker is significant as it may be an indication of an early stage malignancy. This is particularly helpful if seen in cells that if not for the presence of hTERT, would be considered normal or at worst atypical, based on their appearance alone.”
– Dr Michael Choi, Cytopathologist