MYLAB PATHODETECT COVID-19 QUALITATIVE PCR KIT

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) APPROVAL TO FIRST COVID-19 KIT


First Made in India Test Kit to diagnose COVID-19 has got the commercial approval by the Central Drugs Standard Control Organisation (CDSCO).


Mylab PathoDetect COVID-19 Qualitative PCR kit



ABOUT THE TEST KIT 



Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, which specialises in molecular diagnostic kits has developed first made-in-India test kit for COVID-19 in a record time of six weeks


he kit — Mylab PathoDetect COVID-19 Qualitative PCR kit — is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). 


Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation. Mylab has several years of experience in manufacturing RTPCR kits. It manufactures a range of kits at the facility approved by Indian FDA/CDSCO and is compliant with MDR 2017 regulation for manufacturing medical devices of Class C and D, the most stringent and regulated products by the government. 


Mylab currently manufactures ID-NAT screening kits for blood banks/hospitalsQuantitative HIV, HBV and HCV kits. Mylab has also received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility. The Mylab COVID-19 kit had been evaluated at the Indian Council of Medical Research (ICMR).


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HOW THIS KIT WOULD BE BENEFICIAL?  



Currently, India ranks lowest in terms of testing done per million population. The number is as low as 6.8. Countries like South Korea and Singapore have been able to contain the growing number of Coronavirus cases by enhancing the number of testing.


So far, the Indian government has been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN-India. However, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. This can change with the approval for made in India kits.


As claimed by the Mylab, it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1000 patients a day. With local sourcing of test kits, it will be a breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost


Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to seven-plus hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions at the same time on one machine.


ABOUT CDSCO



The Central Drugs Standard Control Organization(CDSCO) under Directorate General of Health Services, Union Ministry of Health is the National Regulatory Authority (NRA) of India. Its headquarter in New DelhiUnder the Drugs & Cosmetics Act,1940, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country. 


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