At a time when the COVID 19 cases are nearing 500 in India, increased medical needs and testing infrastructure has become the need of the hour. In a bid to get control over the pandemic, the Central Drugs Standard Control Organisation (CDSCO) gave commercial approval to Mylab Discovery Solutions’ Made in India COVID 19 test kits.
According to the Pune-based molecular diagnostics startup Mylab, the kit named as Mylab PathoDetect COVID-19 Qualitative PCR kit, is the first one to receive commercial approval from the national regulatory body.
The Indian government till now has been importing RT-PCR kits from Germany and Switzerland. This move will help the government reduce its dependency on foreign products and also avoid supply difficulties due to grounded airlines.
The startup also claimed that the Mylab PathoDetect COVID-19 Qualitative PCR kit would cost nearly one fourth of the current procurement cost.
“Since this test is based on the sensitive PCR technology, even early stage infection can be detected with highest accuracy as has been seen during tests at ICMR. The ICMR-tested CDSCO approved kit makes detection faster too,” Shailendra Kawade, Executive Director at Mylab, said in a company press release.
According to the company, it has also received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit and has also been evaluated at Indian Council of Medical Research (ICMR).
How does the kit work?
Speaking with Yourstory, Dr Gautam Wankhede, Medical Affairs Director at Mylab, said that the kits are based on a technology known as RT (Real Time) PCR and thus any lab which would want to use the test kit would need to have the RT PCR instrument.
“There are about 5000 such instruments available across various labs in India. While some of the instruments might be in research lab services that are not involved in patient diagnostics, a substantial amount of these instruments are already present in labs across the country. This is the only instrument required to use the test kit,” Wankhede explained.
According to the company, nearly 100 patients can be tested using one kit. The kit will screen and detect COVID-19 infection within two-and-a-half hours, which is quite less compared to more than the hours taken by current testing infrastructure. Faster testing will also ensure laboratories to conduct more numbers of tests.
Mylab ramping up productions to fight the pandemic
Founded in 2012, Mylab Lifesolutions is aimed at helping enterprises to address their current operations in an efficient and cost-effective manner.
The company claims to have developed the test kit for COVID-19 in a record time of six weeks following the WHO guidelines.
According to the company, it can manufacture up to one lakh test kits in a week which can be further scaled up if needed.
When asked about when the kits will be available with the labs, Wankhede said, “Our team started working on the manufacturing by the end of the day, we should be able to ship out the first few kits maybe tomorrow early morning.”
He also added that the company’s capability once it enters the full gear will allow it to conduct 15,000 tests per day.
“Our capacity is manufacturing 15,000 patient tests a day. Right now there are four to 5000 PCR instruments available across the country and if every lab is given permission to conduct the tests right now, then we will provide more kits which will increase the potential to almost maybe three or four lakh tests per day,” Wankhede said.
(Edited by Dipti Nair)
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