In a major development, Pune-based molecular diagnostics company Mylab Discovery Solutions has been given the go-ahead to develop testing kits for the novel coronavirus disease (COVID-19).
The organization came up with a highly accurate diagnostic solution in the record time of six weeks, becoming the first Indian company to receive the commercial approval to mass-produce kits.
Here's all about its work.
Mylab and its polymerase chain reaction test kit for COVID-19
The new 'Made-in-India' diagnostic tool, dubbed Mylab PathoDetect COVID-19 Qualitative PCR (polymerase chain reaction) kit, has been validated by both the Central Drugs Standard Control Organization and the Drug Controller General of India.
It has been developed as per the guidelines issued by the WHO and CDC and is reportedly the only indigenous kit that worked with 100% sensitivity and specificity in the evaluation.
Faster than normal kits
Along with being highly accurate, the new homegrown kit is also faster than the ones used currently.
Specifically, the ones in use today give out results in 5-7 hours, while the Mylab's product is capable of screening samples and detecting COVID-19 infection in just 2.5 hours.
The kits can reportedly study around 1,000 large lab samples and 200 from small labs.
Even early-stage infections can also be detected
"Since this test is based on the 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," said Shailendra Kawade, Executive Director at Mylab.
Price to be kept on the lower side
Mylab says it's going to price its new kits around Rs. 1,200, which is a quarter of what the Indian Council of Medical Research is currently spending to procure test kits.
The research body currently has 1,00,000 kits and has already placed an order for 2,00,000 from Germany.
Now, Mylab's work could increase this number, boosting the testing capacity of the country for COVID-19.
So far, COVID-19 has killed 10 in India
The effort to scale up testing comes as India witnesses the evolving COVID-19 situation. So far, the disease, which has killed thousands in Italy and China, has infected 500+ individuals and claimed 10 lives in the country.