Though, India witnessed a positive response on the ‘Self-Reliant' and ‘Made in India' initiative, if it comes about survival, what will you prioritise, Health or Made In India? Yes, you read it right. Not only India but the entire world is reeling under the pandemic which has taken the toll to millions and if something is utmost imperative currently, that is the well-being of the entire human community irrespective of their country, race, religion, caste, etc. Even for the past few months, the superpowers and the developing ones are coming under one umbrella to spot a solution to combat the common enemy yet, tragically, couldn’t discover one. As the COVID cases in India continue to skyrocket, the sacrifice and suffering of the longest lockdown seem like a lost cause. If not an antidote then at least the testing and preventing part ought to be given extreme importance for now to restrict the spread.

Along these lines, PropAssist Global Solutions and Medisys Corp together introduced a unique COVID testing procedure, VERI-Q PCR Test, developed by a South Korean Biotech company, Mico BioMed, which strives to be cost-effective, user-friendly and can detect the outcome within 30 minutes. The machines are ideal for use in airports, ambulance labs, ramping up capacity in existing labs or for setting temporary testing labs in high patient density areas that require surveillance.

Machine Maker engaged in an interaction with Bobby Surendranath, Director of Prop Assist Global Solutions Pvt Ltd, where he expressed, “India is the 4th most infected nation in the world and will soon reach rank 1 unless effective steps are taken for mass testing to quickly isolate the infected. In fact, India, on the contrary, is struggling with testing outlets in Government hospitals and has a 6-month long process of giving NABL certification to open labs. Thus, as a solution, we are representing Mico BioMed in India, as they are willing to extend the US FDA approved testing machines to Indian hospitals for free while the individuals will only have to pay for the testing kits”.

Why VERI-Q PCR Test over others?

The need of the hour is to increase reliability and speed of testing while reducing the expense and hopefully the VERI-Q PCR Test can serve this purpose well. Clarifying this Bobby stated that the R-T Antibody test (available for Rs 500-800) which claims to be low cost and fast, is extremely unreliable as the ‘anti-bodies’ appear in the bloodstream often after 6-7 days of infection and in case of an asymptomatic patient, the bloodstream doesn’t even carry the antibodies, although they carry the infection in their nasal passages and can infect others through droplets. 

WHO has already confirmed that over 50% of test results using Antigen kits fail and should not be used as a confirmatory outcome. In fact, ICMR additionally called attention to this issue a few times through notices and recommended these tests only for quick screening but still, it is the predominant form of testing in India because of its affordability and less time consumption

Further, if we take a gander at the Gold Standard Testing that gives highly reliable results through RTm PCR Tests, then they are based on samples taken from the throat which is tested to confirm the presence of RNA/DNA of the virus. Even though it’s an effective procedure, it takes around 5-6 hours to detect the outcome and costs quite expensive (including testing kit and expensive machinery required). Moreover, it requires an air-conditioned environment along with highly trained professionals for operating the complex machines and conducting the tests. “Although there has been an announcement of a 50% drop in testing prices, it is still not enough as post the cut it will cost around Rs 9000 for a family of four. Indeed, on an average PCR test result takes up to 2 days as the samples need to reach a centralised laboratory before they can be processed and this delay can affect patients seeking emergency treatment for other illnesses as well,” says Bobby.

Furthermore, he added that even if the PCR kits are made available at Rs. 200, a lab will initially need to invest in testing machines, office space, air-conditioning, battery backup power, trained technicians etc which will add up to about Rs. 2-3 crores as a start-up cost. Now, it might happen that out of nowhere the entire COVID terror comes to an end, as vaccines and cures get developed. Hence, the majority of diagnostic labs are reluctant to ramp up capacity by making upfront investment and are looking for rental/ lease solutions on the machines.

Features of VERI-Q Testing

Mico BioMed has recently revolutionized the COVID testing process by developing VERI-Q PCR test which is extremely valid as the machines utilise highly acclaimed Lab chip technology to provide 100% confirmatory results within 30 minutes. Focusing on its features Bobby mentioned that the testing system incorporates an Extraction and a PCR machine which together weighs just 15 kgs, making it easy to operate and portable. In fact, they can be carried to any remote location without any inconvenience. It doesn’t require a lab environment and can be effectively operated by anyone with basic training, meanwhile, it can conduct up to 650 tests per day.

A testing kiosk in the highly populated containment clusters can even accelerate detection along with the isolation of patients in remote towns with no large hospitals nearby

Bobby included that these machines can run on battery for 24 hours, unlike the traditional PCR machines. And not just COVID but it possesses the ability to detect a wide range of diseases (50 approx) including malaria, TB, dengue etc and henceforth, can be concluded that we have an all in one solution that delivers result as fast as the RT test yet is a lot cheaper to start up with (zero initial cost of machines and low-cost testing kits).

Approvals and marketing approach

The BioMed testing machines and kits are being supplied to over 17 countries where it has filed patents for their products and the COVID testing system is approved by CE-IVD and USFDA. In fact, these BioMed products are approved by ICMR and CDSCO for distribution and sale in India.

Discussing the marketing approach Bobby stated that if in spite of the conventional PCR tests in private labs (which currently cost between Rs 2200-6000/test depending on the state) people in volume opt for VERI-Q PCR Test, then they can envisage the current price to fall below Rs 500 per test in few months.

Difficulties in commercializing

Though India is grappling with a severe shortage of good quality testing kits, bureaucratic confusions over technical specifications and an aversion by the Regulators to bring in foreign technology due to the ‘Made in India’ catch phase has kept most foreign companies out. This has created a huge impediment in circulating the machines. Emphasizing on it, Bobby shared, “Several Indian companies have got their kits approved in India but they do not have required production capacity to meet local demand. Despite the fact that we have the solution, Indian Public is highly reluctant to USFDA and CE-IVD approved products by internationally reputed companies due to the economies of scale of production”.

He referenced that, despite 4 months of Corona’s appearance in India, only 50 lakh people got tested (Less than 0.5 of the population) as per ICMR. “Unless we test and quickly isolate the sick, the Coronavirus will simply play the rounds for several more months, appearing in new pockets as the old ones recover”, says Bobby. He added that Universal testing is expensive unless we drastically cut down the cost of testing by increasing volumes. Lastly, concluding the conversation he urged, “Our regulators need to seriously consider if a stringent ‘Made In India' mentality is worth sacrificing in favour of saving millions of lives”.

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