Tata Medical and Diagnostics has developed a kit “OmiSure” for detecting Omicron variants in RT-PCR Tests
Tata Medical and Diagnostics has developed a kit called “OmiSure” that can detect Omicron variants of SARS-CoV2 in nasopharyngeal / oropharyngeal specimens during RT-PCR testing. As per the company’s press release, the test kit is compatible with all standard real-time PCR machines. This kit can detect Omicron variants as well as other variants of SARS-CoV2 reported so far.
Currently, patients with Omicron are detected only after genomic sequencing. This test helped eliminate that step and could make detections during the test. The kit was developed to detect new variants of SARS-CoV2 directly and very specifically. Head of Research and Development , TATAMD said the first target is based on the S gene dropout or S gene target disorder (SGTF) and the second target is based on the S gene mutation amplification (SGMA). The Indian Council of Medical Research (ICMR) has approved the kit.
Presently, the Omicron variant is being detected using test kits developed by US-based Thermo Fisher which uses S-Gene Target Failure (SGTF) technology, which is also used by OmiSure.
In its letter approving the kit, the ICMR stated: “The tests have been performed as per the manufacturer’s instructions. Responsibility for batch-to-batch consistency lies with the manufacturer.”
The company had applied for a license with the Central Drugs Standard Control Organization (CDSCO). The kit will be manufactured by TATAMD at the Sriperumbudur facility in Tamil Nadu once the license is approved by the CDSCO. The company currently has daily capacity of 2,000,000 kits and plan to increase the capacity from 5,000,000 to 10,00,000 by the third week of January. The kits are manufactured in both the domestic and international markets. The company also applied for a patent for this kit .
Download the ICMR Approval here