Company obtained manufacturing licence from CDSCO and is awaiting clinical validation of kit, which uses gold-standard RT-PCR method.
A human monkeypox virus (MPXV) multiplex RT-PCR detection kit was released by Minister for IT and BT and Science and Technology C.N. Ashwath Narayan on Friday.
Developed by NeoDx Biotech Labs, the MPXV kit is designed for specific detection of the Central African (Congo Basin) and West African Monkeypox virus clades. The kit uses gold-standard Taqman chemistry-based RT-PCR method.
The company has obtained the manufacturing test licence from Central Drugs Standard Control Organisation (CDSCO), under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, and is waiting for clinical validation of the kit, according to a press release.
The kit was released on the occasion of the foundation-laying ceremony for the “Research and Training Unit for Rare Diseases” held at the Centre for Human Genetics (CHG) in Bengaluru.
The CHG, under the guidance of the founding Director, Professor H. Sharat Chandra, for the past 20 years, has been providing high quality genetic services to patients with rare diseases from all over Karnataka and other states, the release said.
Meenakshi Bhat, Associate Director at CHG said nearly 35,000 families with genetic disorders have been diagnosed and counselled in the past 15 years. “The genetic laboratories at CHG provide diagnostic testing in around 5,000 patients per year. The majority of these patients are from government hospitals in Karnataka and these services are provided free to BPL and other eligible patient families and at cost to others,” she said.
The Research and Training Unit for Rare Diseases is an extension of the present CHG building. This 40,000 sq. ft extension will have three floors in which comprehensive genetic counselling facilities for around 2,500 families with rare disorders will be evaluated annually, she said.
content/source: thehindu.com (headline edited)