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Our COVID-19 RT- PCR test kits are approved for use in over 50 countries

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Given the unprecedented nature of the COVID 19 pandemic, Thermo Fisher Scientific’ has scaled up production of their RT-PCR assay kits from 50 thousand to 10 million a week. Amit Chopra, Managing Director – India and the Middle East, Thermo Fisher Scientific explains more about the company’s effort in vaccine development and COVID-19 testing in an interview with Akanki Sharma  

Tell us about the diagnostic testing and vaccine development technologies by Thermo Fisher Scientific to manage COVID-19 pandemic in India and across the world.

Thermo Fisher Scientific has been at the frontlines of the global response to this crisis, from early analysis of novel virus to developing new diagnostic tests, supporting our biopharma customers in their development of new therapies and vaccines and providing personal protection equipment (PPE) to scientists, healthcare workers and first responders.

Researchers are using our Thermo Scientific Krios cryo-electron microscope to determine the structure of the virus. These findings are paving the way to accelerate the development of treatments and vaccines. The most important step is the viral specimen collection and its safe transportation. The US Federal Drug Administration (FDA) has approved the Thermo Scientific Viral Transport MediaMicroTest sample collection kits that help maintain the sample integrity until it reaches the testing laboratories.

We are also providing personal protective equipment (PPE), water purification systems and other laboratory essentials like CO2 incubators, refrigerators and centrifuges for sample processing. We have quickly developed the Applied Biosystems TaqPath COVID-19 Combo Kits, a real-time PCR (RT-PCR) based molecular test which is considered the gold standard. We offer a complete workflow from viral RNA extraction and genetic analysis using multiplex RT-PCR to diagnostic report generation within four hours. The TaqPath COVID-19 Combo Kit is also EUA US FDA approved and used by clinical and public health laboratories to evaluate samples on 96 wells and high throughput 384 wells RT-PCR systems. Our recent collaboration with Mayo Clinic and WuXi Diagnostics to develop a serology-based anti-body test will also significantly complement our PCR-based diagnostic test and will be a vital step to contain the spread of the virus.

How many kits have been developed till date and whom are these provided to?

The scale and depth of our capabilities and expertise in the response to COVID-19 is unmatched. As of today, our COVID-19 RT- PCR test kits are approved for use in more than 50 countries, including India. We have scaled up production of our RT-PCR assay kits from 50 thousand to 10 million a week, given the unprecedented nature of this situation.

We have collaborated with several states, private labs, other government testing labs and medical colleges to help them ramp up their testing capacity and ensure they get timely supplies. We already had the largest install base of RT-PCR in the country and have significantly ramped up new install bases in the country as well. Additionally, we are working with several pharma and biotech customers to provide required technologies that accelerate their research and support to scale a therapy or vaccine for the virus.

To ensure uninterrupted supplies, how are you navigating relationships across the regulatory network, the Centre and the State Governments, and vice-versa?

Governments, healthcare providers and pharmaceutical companies are battling COVID-19 on different fronts. As the world leader in serving science, we recognise the significant role we play in helping our customers navigate this crisis. Our efforts are to make sure all our customers, including central and state government institutions, have access to our wide portfolio of products. We have been proactive in aligning all our stakeholders via extensive communications and our efforts are to provide them access to our full suite of testing options, ramp up our testing capacities and give assurance on supplies.

Is Thermo Fisher Scientific working on vaccine development for COVID-19?

At Thermo Fisher, we are working with companies globally on vaccine candidates. Our wide portfolio of technologies and products are used at both the upstream and downstream stages of vaccine research and bio-production.

For instance, in the upstream process, we have our single-use technologies (SUTs) that include the bioreactors, the single-use bags and cell-culture media and cell lines. Additionally, we also offer chromatography purification media used extensively in the downstream process. So, as technologies get developed and clinical trials continue, vaccine manufacturing companies are partnering with large biopharma companies regionally to scale-up production of the vaccines when they become available. However, the need now is to respond to the current pandemic, prepare for waves of outbreaks until we have a vaccine, and then be more prepared for the next wave.

As companies are starting to re-open, what are your thoughts on an approach to testing and the availability of tests?

While social distancing, face masks, hygiene and other measures are important to help keep people safe as business ramps up, testing plays a critical role in gaining confidence while reopening economies. There is a need to quickly identify cases, isolate them and treat patients appropriately. Secondly, we are working at several levels to ramp the scale to test or bring therapies to manage symptoms and ultimately support the acceleration of research and development of vaccines.

At Thermo Fisher, our approach is to minimise risk and ensure overall health and well-being of our colleagues while we continue to meet customer expectations for product supply.

How is the company managing to keep the supply chain moving and what precautions are being taken to prevent the spread of the virus amidst the COVID-19 pandemic?

At Thermo Fisher, our approach involves a globally coordinated response, comprehensive site preparedness, employee training and communication and robust business continuity planning. As the government eases restrictions, we are following a careful and coordinated plan to safely and gradually bring more employees back to work. Our well- defined protocols ensure the safety of our colleagues while we continue to serve our customers. At the moment, we are not experiencing any significant supply issues for most of our products in India and globally. With respect to the transmission of the virus from goods being shipped, we are taking our guidance from the Centers for Disease Control (CDC) and the World Health Organization (WHO). While survivability of the virus on various surfaces is not fully understood, there is currently no evidence to support the transmission of COVID-19 associated with imported goods.

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