Mylab Discovery Solutions, the little known Pune-based molecular diagnostic company, shot into limelight after it became the first Indian company to receive commercial approval to supply RT-PCR kits for novel coronavirus, or COVID-19, testing. The three-year old company developed this testing kit within six-weeks of the outbreak.
Mylab says it is ramping up capacity and can produce up to 20 lakh test kits per week in a month’s time. “We specialise in the test based on genetic material detection (RT-PCR testing),” said Hasmukh Rawal, Promoter and Managing Director of Mylab to Moneycontrol, citing the reason behind company’s swiftness in launching the test kit.
The RT-PCR test kit consists of reagents, positive control and an internal control. To put it simply, it is like a ready to use recipe. A swab sample taken from the nose is processed using a RT-PCR machine to detect the presence of SARS-CoV-2 virus.
The advantage of using a RT-PCR test kit is that it is accurate. RT-PCR based tests detect genetic material of virus in the sample rather than looking for antibodies, which detects response of the human body to the virus and is reliable only after the patient has developed antibodies.
The key feature of RT-PCR based test from Mylab, however, is that it cuts down the time taken. Mylab said its test kit called PathoDetect COVID-19 Qualitative PCR kit has enabled labs to reduce the time taken for a single test to 2.5 hours from 7.5 hours, greatly enhancing capability to test more persons for COVID-19.
Further, the test kit has 100 percent concordance among true positive and true negative samples, indicating its high accuracy.
While this is fine on paper, Mylab had to find a way to scale up its manufacturing of test kits. It needed funds to scale up operations, buy reagents, secure logistics and get its supply chain in place.
The company bagged Rs 1 crore from Action COVID Team Grants— a grant set up by top fund managers and blue-chip venture capital firms to back fledgling firms that on products and services to combat COVID-19.
But that wasn’t going to be enough, soon Mylab found two investors partners Adar Poonawalla, CEO of Serum Institute of India, and Abhijit Pawar, Chairman of APG. They invested an undisclosed amount into the company, which is helping in ramping up capacity.
“We are in middle of ramping up our capacity. In March, our capacity was about 1.4 lakh per week, but we are ramping it up. If need be, we can go up to 20 lakh per week in a month,” Rawal said.
Testing, contact tracing, and quarantine are three major tools deployed to effectively contain COVID-19 globally.
India, with a 1.3 billion population, has so far undertaken 2.75 lakh tests. South Korea, with a population of about 50 million, conducted over half a million tests. The reported cases in India zoomed to 12,456 cases.
With a delay in procurement antibody test kits, India is relying on RT-PCR testing. But so far prices of these test kits remains a problem. Indian government has capped the price of COVID-19 test in private labs at Rs 4,500. The price includes the cost of the test kit.
Mylab is offering the test kit at Rs 1,200. The management said it is open to review its pricing once it achieves scale.
Another promoter and Chairman Shailendra Kawade said the company is working hard to scale up. “We are working with various organisations to ensure that we are able to procure raw materials and deliver kits to the labs across the country,” Kawade said.
Kawade added that the company with 50 employees is working in double shifts to meet the demand.
The company said it has no plans at the moment to get into manufacture of anti-body test kits.
Small beginingThe company was founded by Rawal and Kawade in 2016. Prior to that, the duo worked at US-based laboratory equipment gaint Thermo Fisher. They made up their mind to develop diagnostic solutions that are affordable and unique. Until now, Mylab has been self-funded, the duo have a trading business and a manufacturing business with a revenue of Rs 44 crore.
The COVID-19 kits are being manufactured at the company’s manufacturing facility in the Lonavala Industrial Estate. The Mylab manufacturing facility, approved by Central Drugs Standard Control Organisation (CDSCO) is compliant with MDR 2017 regulation for manufacturing medical device of Class A,B,C and D and ISO 13485: 2016 certification.
Mylab’s capabilities came to fore when Mylab became India’s first approved manufacturer for RT-PCR based molecular diagnostic kits (ID-NAT) for detection and quantification of HIV, HBV and HCV.
While not many people aware about Mylab outside, the launch of ID-NAT made medical diagnostic field take notice of it.