On the evening of 25 March 2020, Mylab Discovery Solutions Private Limited, a Pune-based molecular diagnostics startup, announced that it is ready to supply its first batch of Made in India COVID-19 testing kits to government hospitals and private labs.
In the first batch, the Pune startup will supply testing kits to conduct 15,000 tests. As stated in a listicle published yesterday by The Better India, its PathoDetect COVID-19 Qualitative PCR kit was the first one to receive commercial approval from the Central Drugs Standard Control Organisation (CDSCO).
Developed in a record time of six weeks, this testing kit is expected to bump up India’s low rate of testing for the global pandemic COVID-19, which many public health experts contend has hampered our fight against managing it.
Why do we Need More Testing?
According to this DNA report, as of 24 March, India was conducting approximately 16 tests per 1 million compared to South Korea at 6,148. Of course, this figure varies depending on the state. Still, the overall consensus is that India hasn’t tested enough, and thus doesn’t have a pulse on the total number of people affected by COVID-19.
This is precisely why the contribution of firms like Mylab is critical. With more testing kits and tests, authorities in India will get a much better sense of the epidemic.
“At present, Mylab can produce kits to test for 20,000 samples per day. However, in case of an adverse situation, the company can ramp-up its capacity to ship kits to conduct 50,000 tests per day,” said Rahul Patil, Operations Head, Mylab Discovery Solutions, to the press.
How Will Mylab Test Kits for COVID-19 Work?
Speaking to The Better India, Dr Gautam Wankhede, Medical Affairs Director at Mylab, says, “We can scale this up further and double our production within 8-10 days or a little more depending on the requirement. Our wonderful R&D team has worked relentlessly to develop the testing kit for COVID-19. Our kit screens and detects the infection within 2.5 hours as compared to 6-7 hours taken by current protocols, which is less than half the time conventional kits take.”
In other words, laboratories will be able to do twice the number of reactions at the same time on one machine. The company also claims that each kit can test about 100 patients.
“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,” says Shailendra Kawade, Executive Director, in a press release issued earlier this week.
Thus far, the Indian government has been sourcing its testing kits from countries like Germany, but given the grounding of various airlines, this process has run into serious logistical problems.
With Mylab manufacturing India-made kits, there is a chance that authorities in India will overcome this logistical hurdle. More importantly, at nearly one-fourth of the current procurement cost, it is also cost-effective.
Team #MyLab would like to thank #India for support & love. Yes, we are proud to contribute to our nation’s fight against #coronavirus. #mylab #covid-19 #coronakits #mylabdiscovery @PMOIndia. For updates https://t.co/lW48FySJiU or https://t.co/5VKjCgekMO pic.twitter.com/XsIiWtrUJy
— Mylab Discovery Solutions (@MylabSolutions) March 24, 2020
What is Mylab all about?
“As a company, we have been developing and manufacturing high end molecular diagnostic kits for years. We were the first company in Asia and second in the world to have manufactured an approved ID-NAT (Individual Donor-Nucleic Acid Test) screening kit for blood banks and hospitals. With the Coronavirus, we got an opportunity to showcase our strength, utilising our manufacturing and R&D facilities. We are honoured to contribute in the fight against COVID-19,” says Dr Wankhede.
He adds that its manufacturing facility, approved by FDA/CDSCO, is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A, B, C and D, the most stringent and regulated products by the government, and possesses ISO 13485: 2016 certification.
“Mylab has an experience of several years in [the] 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),” says its press release.
With the entry of Mylab, there are expectations that more tests will happen. But authorities can’t get complacent and must ensure more and more rigorous testing. There is no escaping this fact if we want to do a better job of battling the virus.
After all, you can only fight what you know.
(Edited by Gayatri Mishra)