Pune-based Mylabs develops India's first indigenous coronavirus-testing that can bring down costs; ICMR grants approval

Pune based Mylab Discovery Solutions Pvt Ltd has developed a indigenous coronavirus testing kit which has been approved for commerical use by the Indian Council of Medical Research (ICMR).The kits have reportedly been developed in a record time of six weeks and will reduce the cost of testing to a fourth of the current cost.The molecular diagnostic company, which received statutory approvals late on Monday from authorities, can manufacture over 15,000 testing kits per day from its facility at Lonavala in Pune district and the same will be ramped up to 25,000 kits per day, its co-founder Shrikant Patole told PTI.Citing the experience in South Korea, the World Health Organisation (WHO)has been stressing on the importance of tests to fight the pandemic, which has so far claimed nine lives in India. "We have a simple message to all countries – test, test, test. All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded," WHO Director-General Tedros Adhanom Ghebreyesus has said.Though around 500 people have been tested positive for the virus in India so far, experts are bracing for a sharp increase fearing it may have spread across and also point out to a low level of testing in the country. As of 21 March, India had tested only 14,811 people and had one of the lowest testing rates in the world.With the newly-developed kits ''Mylab PathoDetect COVID-19 Qualitative PCR , said Patole the company would be able to shorten the test time to 2.5 hours as against the prevalent 6-8 hours because its team has created a solution that does both the screening and confirmation jobs simultaneously.Its team of 25 scientists started working on the solution six weeks ago, fearing that the crisis may eventually hit India, he said, adding that the company had started as a trading firm in 2012 and diversified into research in 2016.The test for COVID-19 will also pick up positive cases among asymptomatic patients, Patole said, adding that the approvals from the National Institute of Virology(NIV), ICMR and Central Drugs Standard Control Organization (CDSCO) were received after a test sampling on patients at Mumbai's Kasturba Hospital which is the nodal location for treating coronavirus cases.Earlier the ICMR had issued written guidelines which mandated  that only diagnostic kits that have been approved by the United States Food and Drugs Administration (FDA) or certified by the European Union (EU) be allowed to offer commercial tests for detecting SARS CoV-2. However, ICMR Director General Dr. Balram Bhargava on Monday said this was no longer a requirement and even those approved by the NIV would be eligible for approval, said a report in The Hindu.Patole explained that till now, India has been using kits prepared by the state-run National Institute of Virology (NIV), also based in Pune, but it was the fears over the increase in numbers which made private sector interventions in manufacturing necessary.The testing kits done by NIV are costing up to Rs 4,500 per sample if we include both screening and confirmation, Patole said, claiming that Mylabs is confident of selling the kits at a fourth of that cost.He said allowing private labs to conduct tests is essential given the potential threats. Patole also said that its kit can work within the infrastructure for testing available with Indian diagnostic labs, and does not require any new machinery. The company is in the process of creating similar test kits for HIV, hepatitis-B and also tuberculosis.A team of four founders and investors have invested over Rs 25 crore in the company till now and there are no external investors, Patole said. The company is looking to rope in investors, he added.Earlier in the day, the ICMR had said that 118 govt laboratories were included in the ICMR network of testing, with a capacity to test 12,000 samples a day. 22 private laboratory chains, with about 15,500 collection centres, have also  registered with ICMR till today, reported ANI.With inputs from agencies