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“We are Committed to Providing World-class Molecular Tools to the IVD Industry for Reliable Testing of Simple to Complex Disease”

Dhirendra, Prateek

From developing Covid-19 RT-PCR kit to receiving US-FDA and producing more than six million tests, 3B Blackbio has emerged as the go-to solution provider in the biggest healthcare crisis of our modern history, write Dhirendra Dubey, MD and Prateek Goel, Head Commercial Operation at 3B BlackBio Biotech India Ltd.

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The year 2020 made its mark in the timelines of millions. For good or bad, 2020 brought big changes in people’s life and society. In-Vitro Diagnostics (IVD) industry is certainly the one that observed positive changes in the ways it supported the diagnosis of Covid-19 samples. India alone has registered 400% growth in the number of new labs that started molecular testing during the pandemic. By mid-Feb 2021, India has close to 2400 NABL accredited laboratories performing molecular testing. This is a huge step toward making India Atmanirbhar (Selfreliant) for complex disease testing where molecular techniques are proven to be the gold standard.

Covid-19 pandemic is the second pandemic which is managed 100% (in terms of diagnosis) by molecular technologies after the H1N1 pandemic. It was 1865 when Gregor Mendel laid the foundation of molecular biology and after a hundred and fifty years of that revelation, we have entered the era of the molecular way of managing our entire healthcare spectrum. From testing to potential treatment (CRISPR).

Today, it is also worth to remember and feel proud of Nobel Laureate Dr Har Gobind Khurana of Indian origin who became the first known man on the planet to chemically synthesize oligonucleotides and whose work has led to the invention of polymerase chain reaction (PCR), the gold standard and cornerstone technique in IVD industry today.

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H1N1 pandemic in the year 2009 and a decade later, Covid-19 pandemic in 2019-20, saw PCR technology to be the gold standard IVD technique to test patient samples for the genotypic identification of these viruses. PCR and its various modifications like Real-Time PCR, Iso-thermal PCR, LAMP, etc. are reliable tools of identifying organisms based on their unique genetic signatures.

3B Blackbio Biotech started in 2011 with the objective of providing Indian labs molecular tools for reliable testing of patient samples for infectious disease to various complex disease like Cancer. We started researching these tests from the scratch and invested heavily in terms of money, time, and human resources to offer the most reliable solution to complex diseases.

Along with the growth of molecular biology, the diagnostics part is adapting the newer concepts to offer solutions from diagnosis to treatment. Importance of advancing molecular techniques can be seen with the latest Nobel prize in chemistry awarded to Dr Jennifer A Doudna and Dr Emmanuelle Charpentier for their work on CRIPR which can become a potential tool for cutting out disease-causing genetic fragment out of one’s DNA.

I vividly remember, February 2020, when we were at the Dubai Health conference where we observed many Chinese representatives wearing masks and being extra careful with their hygiene. We did not imagine at that time what is coming ahead of us will be full scale pandemic for which we will be developing and providing RTPCR kits at a scale which we could never imagine.

It was only the beginning of March when India started reporting increasing cases and we got ourselves into developing the RT-PCR-based kit. RT-PCR based detection was declared by WHO as the gold standard technique to test patient samples for the presence of virus.

Soon after ICMR approval of our RTPCR kit, we started receiving more than 100 calls a day as we were the only second kit to get approval in India. Demand skyrocketed and from the production capacity of 5,000 tests a day, we started scaling up our efforts to produce more than 1,00,000 tests per day. We thankfully acknowledge the efforts of our production team which worked for more than 20 hours a day in different shifts. We hired many more people to meet the demand. We replicated our production unit and shifted all our focus and energy on meeting the demand for Covid-19 RT-PCR testing kits. We also acknowledge the great efforts by our logistics team who could manage to deliver our kits to more than 100 cities despite total lockdown. From writing the letter for permission of movement across borders to waiting at borders for hours explaining the reason for delivery to law enforcement agencies to various district magistrates, our team finally pulled it off successfully to make sure the test reaches every lab offering Covid-19 RT-PCR testing services.

It was June 2020, when 3B Blackbio Biotech India became the first ever Indian molecular diagnostics company to receive US-FDA EUA (Emergency Use Authorization) to make our mark on the global IVD industry. This led to more than 50 countries enquiring about our kit. We further also received EUA on our RT-PCR kit for Saliva samples. With that, we became only the fifth company to offer US-FDA approved solution for saliva sample testing for patients who find it difficult to insert swabs deep into their nose and throat.

Since Covid-19 is a public health matter, the most important task, and a challenge in front of us was to uphold the quality standards of our kits. For this, we worked with international agencies to import certified and WHO approved reference material to make sure that India produces and uses world-class testing kits to manage this pandemic. Our QC department worked extremely hard to ascertain that only the QC passed kits moves out of the factory gate. We are extremely satisfied to mention that there has not been a single return of lakhs of tests kits we produced and that we could be of service to the nation when it needed the most.

Today, we are happy to acknowledge that more than 400 private laboratories and an almost equal number of government laboratories who used our kits and relied on our quality. It is overwhelming to see how our users have placed multiple repeat orders with us even though there were more than 100 different kits available with time. At the peak of the pandemic in India, in the months of August-October, we observed 70%-plus approved laboratories in most of the big cities using our kits. There was never a more satisfying feeling than seeing our vision becoming reality. A vision of providing world-class, affordable healthcare solutions to all!

By the end of January 2021, 3B Blackbio has produced and sold over 6 million tests not just in India but in other nations too. We are now exporting our RT-PCR kits to countries like the United States of America and that is a huge responsibility on our shoulders to be the only player to represent India on a global scale. With this new zeal, 3B Blackbio Biotech’s team is even more committed to offering reliable and affordable molecular testing solutions to India for its Atmanirbharta and to the entire world.

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