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First ‘Made-In-India’ COVID-19 Test Kit By Pune Based Mylab Gets Commerical Nod

Coronavirus Test Kit Mylabvia
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Coronavirus has stopped the entire world. This coronavirus has spread in more than 192 countries. The World Health Organization (WHO) has already made coronavirus pandemic. India has already more than 500 coronavirus COVID-19 positive cases. The entire nation is almost lockdown and people are requested to stay at their home. Till now there is no vaccine has discovered for coronavirus. Mylab Discovery Solutions Pvt Ltd, a Pune based molecular diagnostics company, that specializes in molecular diagnostic kits has developed the first Made-In-India test kit for COVID-19 in a record time of six weeks.

 

Made-In-India’ COVID-19 Test Kit By Mylab

Coronavirus Test Kit Mylab
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This kit Mylab PathoDetect COVID-19 Qualitative PCR kit is the first one in India to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). Also, Mylab Discovery Solutions Pvt Ltd is the only Indian company to have achieved 100 percent sensitivity and specificity in the ICMR evaluation. The company has many years of experience in manufacturing RTPCR kits. The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A, B, C and D and ISO 13485: 2016 certification.

Hasmukh Rawal, a Managing DirectorMylab Discovery Solutions Pvt Ltd said,

“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 a record time,”

He added,

“The support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation center of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.”

Currently, India ranks lowest in terms of coronavirus testing done per million population with the number as low as 6.8. Other countries like Singapore and South Korea have been able to contain the growing number of Coronavirus cases as they have enhanced the number of testing.

Coronavirus Test Kit Mylab
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Till now, the Indian government has been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients across India. The dependency on foreign kits has been a trouble for the nation as the supply is getting blocked due to non-operations of transports. This can surely change Made In India kits.

Shailendra Kawade, Executive Director at Mylab told,

“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,”

Coronavirus Test Kit Mylab
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This is the major breakthrough for India as the testing kit made by Mylab would cost almost one-fourth of the current procurement cost. Also, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the coronavirus infection within 2 hours 15 minutes as compared with over 7 hours taken by current protocols.  Also, the laboratories will be able to do twice the number of reactions at the same time on one machine. Mylab has also promised that it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed. Also, it claims that its test kits can test around 100 patients with one kit. A normal lab with automated PCR can test more than 1000 patients in a day.

Coronavirus Test Kit Mylab
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Let us stay at home and fight with coronavirus. Because to defeat coronavirus, the lockdown is very necessary. Be safe and take precautions from coronavirus. Recently AIIMS has issued a booklet about everything you should know about coronavirus.

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Praneet Samaiya
the authorPraneet Samaiya