BENGALURU: In a major and global breakthrough towards cutting down procedural delays in genome sequencing to ascertain the Omicron variant of SARS-CoV2, Dr V Ravi, former head of the Department of Neurovirology at National Institute of Mental Health & Neuro Sciences and Head, Research & Development, Tata Medical & Diagnostic Centre, Sriperumbudur, Tamil Nadu, and his team have developed the world’s first test kit, Omisure, that can detect the Omicron variant by combining S-gene target failure (SGTF) and S-gene mutation amplification (SGMA).
“Omisure was approved by the Indian Council of Medical Research on December 30 and, on Wednesday, Tata MD received the licence from the Central Drugs Standard Control Organisation for commercial production,” announced Dr Ravi.
‘Omisure test will take about two-and-half hours’
“Globally, all other test kits for Omicron are either made for gene dropout or mutationspecific detection. Omisure is the first test kit combining both. On evaluation by the Indian Council of Medical Research (ICMR), it picked up all sequence samples with 100 per cent accuracy. We have now received the licence from Central Drugs Standard Control Organisation (CDSCO) and will start production of Omisure for commercial use within a week’s time,” Dr V Ravi said. The Tata MD management on Wednesday decided to fix the maximum retail price (MRP) of a single kit at Rs 250 for the laboratory.
Speaking exclusively to TNIE, the top virologist, said, “Omisure is a regular PCR test and is compatible with all standard realtime PCR machines. It will cut down the waiting time for genome sequencing of Omicron patients, which is currently the practice and is delaying the results. The Omisure test will take about two-and-half hours; from sample collection and RNA extraction to result.”
On the production capacity, he said the Tata MD plant at Sriperumbudur has the daily manufacturing capacity of two lakh kits, but the production will be ramped up to five lakh kits by the end of this month to meet the demand. “We are also planning to export Omisure and we will be filing for CE marking application for FDA emergency use authorisation,” he added.
A total of 2,135 cases of Omicron variant have been detected across 24 states and UTs, according to the Union Health Ministry data as of Wednesday.