Covid-19 test kits to be available immediately, says head of R&D at Mylab Discovery Solutions

Updated on Mar 25, 2020 04:14 PM IST

Minal Dakhave Bhosale, head of the R&D lab at Mylab Discovery Solutions, boasts 10 years of experience in the diagnostic field, primarily in the area of molecular diagnostics of infectious diseases, diagnostic product development and R&D management functions

Minal Dakhave Bhosale(HT PHOTO)
Minal Dakhave Bhosale(HT PHOTO)
Hindustan Times, Pune | BySteffy Thevar, Pune

Pune-based Mylab Discovery is the first in the country to receive approval for the Covid-19 diagnostic test kit, commercially cleared for manufacture by the Food and Drug Authority (FDA), the Central Drugs Standard Control organisation and the National Institute of Virology (NIV). With Sars-Cov-2 infections increasing, test kits are crucial. Minal Dakhave Bhosale, head of the R&D lab at Mylab Discovery Solutions, boasts 10 years of experience in the diagnostic field, primarily in the area of molecular diagnostics of infectious diseases, diagnostic product development and R&D management functions.

At Mylab, she is responsible for product development of molecular diagnostic products, including the Covid-19 test. Bhosale has the experience of working on the swine flu disease at NIV, Pune, during the 2009 outbreak. Here she describes to Steffy Thevar the process, effectiveness and availability of the test.

When did the actual process to develop the kit begin and what were the major challenges you faced?

We started the development process for Covid-19 six weeks ago on an emergency basis looking at the national crisis and need for an indigenous accurate solution for improved management. Challenges we have handled during the development include, accurate design of the product, product validation for 100% sensitivity and specificity in a short-time protocol run, and government approvals on an emergency basis to make the test commercial. Government approvals are the mandate for commercial use of any diagnostic product, but with proper management and stringent sets of protocols, our expert technical team and government support we were able to overcome the challenges, by working day and night on the Covid-19 test. We have been able to develop the first made-in-India test for Covid-19 in six weeks.

Did you observe any mutation and bio-chemical changes in the virus while studying it for the kit?

Our test aims to detect nucleic acid of the virus, based on RT PCR technology, which is very specific for virus detection. The developed test is based on WHO/CDC guidelines and covers specific targets of Covid-19/Sars-CoV-2 where we didn’t observe any mutations during development process. We are keeping an eye on any mutations or changes to the existing coronavirus for further validity or upgradation of the test.

The company claims to reduce testing time and cost for the testing as compared to currently available kits. How has this been made possible?

We have developed a unique formulation for test reagents that increases the catalytic activities of the enzymes, reducing the enzyme unit requirement, resulting in reduced cost. Mylab’s proprietary reagent formulations offers significant cost advantage.

We have achieved Covid-19 testing in only two-and–a-half hours compared to other tests which are six-seven hours. We did this by utilising our expertise of development processes and FAST mode acting reagents.

By when will it be available? Does it require any special training to use?

As we have received ICMR and FDA/CDSCO approvals for commercial use of PathoDetect COVID-19 Qualitative PCR kit, it will be available in the market immediately. We have started the manufacturing process for the Covid-19 kit and have a capacity of one lakh tests per week.

Our kit insert provides all necessary instructions for use and of course, our application team is available 24x7 for emergency support, training and any technical queries.

The company claims that Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation. What does that mean - sensitivity and specificity?

ICMR has evaluated the Mylab Covid-19 kit for its performance in clinical sample testing. Mylab claims to have 100% sensitivity and specificity based on the ICMR report of 100% concordance among true positive and true negative samples in their evaluation.

Mylab bit brand name: PathoDetect COVID-19 Qualitative PCR kit

Generic name: Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples

Product description: Mylab Discovery Solutions PathoDetect TM COVID-19 qualitative PCR kit is an in vitro RT PCR (rT-PCR) assay for the in vitro qualitative detection and discrimination of 2019-Novel Coronavirus (2019-nCoV) in respiratory specimens and sera.

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