How has Premier grown into the company it is today?

I founded Premier in 1996, and the company has grown since into one of the top three global diagnostics companies, currently manufacturing over 200 million tests per year, all from India. We are one of the premier suppliers of malaria, HIV, and hepatitis tests for low and middle-income countries, primarily in Africa, Southeast Asia, and Latin America. Our products have been exported to 125 countries, and our primary customer base includes UN-affiliated agencies like UNICEF and UNDP as well as government agencies like USAID and the CDC in the US. We also work with some universities in the US to come up with novel technologies for infectious disease testing, which is why our development operations are based in New Jersey. In this way, we transfer new technologies and knowledge from the US to India, where we manufacture at a high volume and low cost.

What approach does your company take to navigating the balance between quality and affordability?

Quality demands price, but we are trying to meet quality at the lowest possible cost. Since the outbreak of Covid-19, the market has shifted towards self-testing. We are planning to offer various diagnostics tests people can do at home because laboratory work can be very expensive.

Premier has the world’s most sensitive and accurate HIV self-test that can detect recent infection. It is currently undergoing evaluation by the CDC. Once it comes out, it will provide detection as early as within six months of infection, far faster than current professional tests that require a minimum of 1.5-2 years of infection before detecting antibodies.

When it comes to making testing affordable, we specifically look for new technologies that are easy to use. For example, a PCR machine may cost US$30,000, which not every testing site can afford, and countries may require thousands of these. Premier works to devise a middle ground technology, such as one that detects an enzyme in a pathogen responsible for infections.

Can you outline the logistical and regulatory challenges that remain in implementing point-of-care testing tools on a large scale in India?

India has an incredibly fragmented distribution network. Instead of a centralized distribution system, the country has thousands of small mom and pop distributors that work in specific geographies. With no large-scale distributor to reach the lowest possible level, it is very inefficient to reach all levels of a consumer base at the clinical level. Given the costs associated with trying to do so, Premier has avoided India’s consumer market. In addition, the regulatory landscape is unfavorable for companies like Premier that produce medical devices that adhere to high quality standards. India had no policy for self-testing before the pandemic, and they have yet to properly implement a centralized regulatory framework for these types of tools. Our company has the efficiency of scale of being among the largest manufacturers of point-of-care tests, meaning we have our manufacturing costs basically as low as possible. Yet there are Indian companies that claim to manufacture the same product for much cheaper. How are they able to do so? They create products that are far inferior or even defective. We saw this during the outbreak of Covid-19 in India; people were positive but getting negative results from faulty tests, contributing to such a fast spread of the virus.

In what ways did the pandemic impact the diagnostics space?

We strongly believe the pandemic changed the testing landscape, from professional lab testing to self-testing, which is why we have invested heavily in developing self-test products for various diseases at affordable prices. This is where the market is heading. If we take this projection a step further, innovative technologies will allow for tracking these incidences in addition to testing for them. We created a digital tool with an affiliated mobile app that allows government-run institutions or labs to collect data instantly in real time at the program level. This will revolutionize disease management, allowing organizations to begin treating an infected person before they infect other people.