Pune: In order to scale up the operations and escalate faster delivery of testing kits for the novel coronavirus (Covid-19), Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd has partnered with Serum India’s CEO Adar Poonawalla and Abhijit Pawar, Chairman of APG. Funds invested will be used for scaling production of COVID-19 testing kits and expansion of molecular diagnostic solutions.
“We are honoured to stand by our Prime Minister and our government, while supporting them during these trying times. This partnership will ensure we do our bit to help in this time of crisis.“ said Abhijit Pawar, Chairman AP Globale, MD – Sakal Media Group
Talking about the partnership, Serum Institute India’s CEO Adar Poonawalla said/-, “In the next few weeks we will be ramping up the production of the Covid-19 testing kits taking from 1.5 lakh tests/week to 20 lakh tests/week. The shortage of testing kits will come to an end in a month or two”.
“This partnership can Impact Billions of people across the world ,especially India“, said Hasmukh Rawal, MD, Mylab Discovery Solutions. Mylab is the first Indian company to get commercial approval for its testing kits named as Mylab PathoDetect COVID-19 Qualitative PCR kit. The testing kit is approved by Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and ICMR evaluation. “This will help Mylabs create a world class organization, which will help India become a leader in molecular diagnostics’’, noted Sujit Jain, Director ,Mylab Discovery solutions Pvt ltd, MD Netsurf
“Global innovation is the need of the hour to curb this pandemic that has affected millions across the world. The need for the maintenance and manufacturing of medical and healthcare equipment at the pace required to keep the numbers at bay has never been more important. Mylabs and their team have shown exceptionally innovative capabilities when they were able to develop a time-saving testing kit within 6-weeks of its outbreak. Keeping in mind their resilient approach and quick response, I am certain that the company has a variety of similar innovation-driven projects which will help bring drastic improvements in the healthcare sector. The investment towards Mylab will enable them to build their infrastructure and expand their capabilities further.”, said Adar Poonawalla, CEO, Serum Institute of India
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. The legal advisory for this partnership was led by Hitesh Jain, Managing Partner, Parinam Law Associates.
About Mylab Discovery Solutions
Mylab Discovery Solutions Pvt. Ltd. is an Indian biotechnology company with focus on advanced In-Vitro Diagnostics. The company offers a wide spectrum of molecular diagnostics solutions, developed in-house by its R&D team in Pune, which helped it become the first Indian company to get commercial approval for COVID-19 test kits in India, with 100% concordance results. In 2019, Mylab became India’s first FDA (CDSCO) approved manufacturer for RT-PCR based molecular diagnostic kits for detection and quantification of HIV, HBV and HCV. This was followed by NatSpertTM, Individual Donor Nucleic Acid Amplification Test (ID-NAT) screening kits for blood banks and hospitals, thereby becoming the first company in Asia and 2nd company worldwide to manufacture ID-NAT kits approved by regulatory bodies. Mylab aims to simplify disease detection and to make it affordable with the state-of-the-art technology. Mylab is also working on a Sample-to- Result machine to automate IVD processes. Mylab a home grown R&D company from India with vision to contribute to clinical diagnostics, pharmaceutical drug discovery, biomedical research, agri genomics and animal and food safety at global level.
About Adar Poonawalla, CEO, Serum Institute of India (SII)
Adar Poonawalla is the Chief Executive Officer (CEO) and the Executive Director of Serum Institute of India. Apart from being among the leading businessmen in India, Mr. Poonawalla has helmed the cause of global immunization cover and endeavors towards achieving 100% cover for denizens. Setting an example among top CEO’s in India Adar has championed various causes including – Adar Poonawalla Clean City Initiative and Adar Poonawalla Maharashtra Tennis Academy. Additionally, in 2011, he founded the Villoo Poonawalla Foundation, focusing on Healthcare, Education, Water, Sanitation and the Environment.
About AP Globale (APG)
AP Globale, a positive Impact Business Solutions company, with interests in diverse businesses, including Sakal Media, will be helping Mylabs, scale its operations within India and globally. Abhijit Pawar, Chairman of APG, will be joining the board of the company.
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- Mylab is the first Indian company getting commercial COVID-19 PCR kit approved by CDSCO
- Mylab COVID-19 test kits cost nearly one-fourth of the currently procured kits
- Mylab uses advanced protocols which can reduces testing time by 65%
PUNE: As India fights back the epidemic COVID-19 (aka Coronavirus), limited testing facilities and expensive testing kits has become the biggest concern for the authorities. In order to combat this challenge, the Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd which specializes in molecular diagnostic kits has developed the first made in India test kits for COVID-19 in a record time of six weeks. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Further, Mylab is the only Indian company to have achieved 100% sensitivity and 100% specificity in the ICMR evaluation.
Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, “With emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit, has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time”. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.
Mylab has an experience of several years in manufacturing of RTPCR kits and manufactures a range of kits at the facility approved by Indian FDA/CDSCO and compliant with MDR 2017 regulation for manufacturing medical devices of Class C and D, the most stringent and regulated products by the government, Mylabcurrently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. Apart from this, Mylab has 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 has been evaluated at Indian Council of Medical Research (ICMR).
“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 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”, said Mr. Shailendra Kawade, Executive Director at Mylab.
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 doing more and more testing.
So far the Indian government is 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.
Mylab promised that it can manufacture up to 1 lakh tests in a week which 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 major 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 7+ hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions in the same time on one machine.
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
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