Made-in-India COVID-19 test kit by Mylab gets validation for its Covid-19 diagnostic test kits
As India is battling against the COVID-19 outbreak (aka Coronavirus), inadequate testing facilities and costly test kits have become a major issue for the authorities. To overcome this issue, “Mylab” a Pune based molecular diagnostic company has developed the first made-in-India COVID-19 test kit named Mylab PathoDetect COVID-19 Qualitative PCR kit. This company has also received approval for commercializing made-in-India Covid-19 test kits from the Central Drugs Standard Control Organisation (CDSCO).
- Mylab is the first Indian company to receive CDSCO approval of commercial COVID-19 PCR kit
- Mylab COVID-19 test kits cost about one-fourth of the kits currently being procured
“With an emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kits, have been made as per WHO/CDC guidelines. It was developed and evaluated in record time”, said Hasmukh Rawal, Managing Director, Mylab Discovery Solutions.
The cure to Coronavirus is the need of the hour. Such a global impact of this pandemic virus is first of it’s kind, mankind has ever known. But before finding the cure, we need to test the presence or absence of the virus in the human body. Various researches have been going on to find an efficient way to test people in India.
As India fights the Covid-19 spread, the government has come under criticism for not doing enough tests. The Indian Council of Medical Research (ICMR) has so far limited the tests only for patients with a travel history and those who are “suspected cases” of Covid-19. India ranks lowest in terms of testing done per million population. It is testing 15 people in 1 million.
However, the government’s research body has been looking to expand its testing criteria. It allowed a few private labs to start providing tests under a prescription from a qualified doctor. However, these labs can’t start testing unless they get the reagents or testing kits required to start these tests.
First Indian Company
In such circumstances, Pune based molecular diagnostic company Mylab has become the first Indian company to have received the validation for its Covid-19 diagnostic test kits also known as the Reverse transcription-polymerase chain reaction (RT-PCR) tests by the Drug Controller of India, after the National Institute of Virology validated its test. The other company to have received the approval is Germany’s Altona Diagnostics.
“We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on sensitive PCR technology, even early-stage infection can be detected, with the highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too”, said Mr. Shailendra Kawade, Executive Director at Mylab.
Faster Indigenous kits
In the current lab-based testing it takes four hours for test results to come out, Mylab’s turn around time is 2 1/2 hours, said Dr. Gautam Wankhde, Medical Director Mylab to ET. The company’s kits can study 1000 samples from large labs and 200 from smaller labs. Mylab is looking to price its kits around INR 1200.
ICMR currently has 100,000 test kits and Mylab says it can make another 100,000 in just a week. However, ICMR has also ordered 200,000 test kits from Germany. The Mylab PathoDetect COVID-19 Qualitative PCR kit was developed in six weeks. These indigenous kits are faster than normal kits. Mylab’s kits screens and detects the infection within 2.5 hours as compared with 7 hours taken by the current protocol.
Mylab has assured that it can produce up to 1 lakh test in a week which can be further increased if necessary. India is now officially ready to take up more tests, thanks to Mylab. We all hope this helps the entire nation to work our way out of this deadly situation.
Stay Safe, Stay Home.