The New Diagnostics Marketplace In A Post-COVID-19 World

Responders like Jyri Engestrom are using coronavirus tests right out of labs in the front lines of a real pandemic. The current crisis is bringing new diagnostics technologies to the marketplace that will change health care in the post-COVID world.

Speaking by cell phone video and standing in front of temporary testing tents set up in the small California town of Bolinas, Jyri Engestrom took time out from the front lines in the fight against coronavirus long enough to share with researchers how the field’s state-of-the-art diagnostics operate in the real world.

“We just finished collecting samples for COVID-19 antibody and RT-PCR testing for the entire population of Bolinas.” 

Engestrom, Partner and co-founder at Yes VC, spoke during a SynBioBeta virtual town hall I hosted on Friday, April 24, delving into the evolving diagnostics market in the midst of COVID-19.

COVID-19 has brought the diagnostics market into the spotlight and exposed a rapidly growing need for better testing capabilities to not only to fight this and future pandemics, but also transform the nature of healthcare delivery. 

“These are the conversations that need to happen,” said Ursheet Parikh, partner at venture capital firm Mayfield. “It has been easier to sell a pill to solve the problem instead of addressing what the problem is. But as the world moves towards precision medicine, precision starts with the difference and the state of each individual – where diagnostics are much more relevant and important.” 

The panel reaffirmed that there is no shortage of new technology rising to this challenge or people working to address it, leveraging a variety of tools ranging from cutting-edge techniques of synthetic biology to high-caliber logistics that aim to reshape the future of healthcare.

On the synthetic biology front, Mammoth Biosciences, in partnership with UCSF, has developed and validated a high-throughput, CRISPR-based approach to diagnose COVID-19 in less than an hour. Notably, this is faster to run than a regular RT-PCR test, utilizes a different supply chain, and is an isothermal technique, meaning that it does not require changes in temperature to function.  

“This concept [of isothermal-based diagnostic procedures] has been out there for a while but still has a lot of room for improvement, and that’s where CRISPR can play a role,” explained Trevor Martin, co-founder and CEO of Mammoth. “This pandemic has exposed a gap that is bigger than we’ve cared to admit and has been a problem for over a decade. People don’t understand that this isn’t impossible to address.”    

How such tests could be used was made clear by Engestrom, who was following in the example of Vo, Italy by undertaking to test the entire population of a city. His team collected samples for the two major types of tests: one for active infections and another for previous exposure and possible immunity to the virus. The team ran the samples using various protocols to crosscheck results, especially as antibody test validation continues with concerns around accuracy regarding specificity and sensitivity. 

“We’re looking to formalize Bolinas into a playbook that can be replicated worldwide and are starting the same process in the Mission District in San Francisco,” Engestrom said. “It’s important to not overlook the importance of community engagement in healthcare. This can be something that people recognize is important and want to take part in. We too often ignore the power that can have, and ‘never let a good crisis go to waste’ really resonates here because it can catalyze action on a grassroots level in a meaningful way.”   

The shortfall of cheap, plentiful diagnostic tools is something that Lee Hampton, Senior Specialist at the GAVI Vaccine Alliance, has grappled with for years. Previously at the Centers for Disease Control and Prevention (CDC), he worked on preventing, detecting, and responding to outbreaks of diseases such as polio, cholera, and malaria. Now at GAVI (founded by the Gates Foundation and others), Hampton helps develop strategies for making vaccines accessible to millions of the most vulnerable children in the world.

“We don’t have enough vaccine for everyone in the world at the same time,” he said. Hampton and his colleagues have come to understand that good diagnostic information is needed to understand where the hotspots of a disease are located, so you can target outbreaks and more effectively stop the spread of infections.

“There’s a market failure in diagnostics, and we’re trying to fix it especially around yellow fever testing in Africa,” Hampton said. The same principles that define a robust COVID-19 test apply in this arena, with isothermal techniques playing an even bigger role to prevent supply chain breakdowns, slowdowns, and temperature demands of traditional PCR tests. “Diagnostics identify areas of need and help solve big problems to save lives,” he explained. 

While scale is a pressing problem—as demonstrated by the pandemic and prioritized by GAVI—there is also a need for solutions that facilitate speed and accessibility in smaller healthcare situations. LexaGene’s work aims to address that problem by bringing the generation of data at reference lab quality to the point of need. 

“There’s a challenge between sample collection and getting data and that’s a window where the virus can spread. LexaGene’s point-of-care technology fits the situation of a healthcare practice screening ten to twenty samples per day, providing the answer in an hour instead of days,” said Jack Regan, CEO & Founder of LexaGene.

Esther Dyson, Chairman of EDventure Holdings and Executive Founder of Wellville, emphasized just how critical are the logistical hurdles highlighted by Regan and Hampton. 

“The science and the technology is there, but the logistics are not,” she said. “Most people died of cholera because of diarrhea and an inability to get rehydrated – a logistics breakdown. In theory, we could test everyone in the United States for COVID-19, but the challenge is getting the trucks and buses of supplies and people to come and for these people to not be scared to come.” In her view, one shared especially by Parikh, society can combat this problem by creating a sustainable path for people to be healthy in small communities. 

“Today, healthcare kicks in when people are sick,” Dyson further commented. “The real question is how do we keep communities out of the hospital? Healthcare needs to [be viewed in] a longer time horizon in order to incentivize proactive, rather than reactive approaches.”  

“What do we do to reimagine the healthcare system so it’s functional and to set up the incentive for long-term health while also creating a good economic marketplace?” mused Parikh. Recognizing a bias against investing in preventative and early-stage solutions such as diagnostics, he said, “There’s no real current incentive to keep people healthy, and diagnostics are a precursor to treatments that keep people healthy by mobilizing early in the cycle of disease.” 

However, COVID-19 has certainly been changing the inertia of a variety of systems in society, whether in education with remote learning, health with telemedicine, or investment with a shift towards more forward-thinking, long-term solutions.

“We need to keep the conversation going, not just around COVID-19, but also the other infectious diseases ravaging the world that can benefit from these same technologies,” concluded Hampton. If this pandemic has proven one thing, it is that the scientific community is certainly heeding that wisdom – and the diagnostics sector is in for a drastic shake-up with effects that will reverberate far beyond this pandemic, for the good of the future of human health.  

Follow me on twitter at @johncumbers and @synbiobeta. Subscribe to my weekly newsletters in synthetic biology Thank you to Aishani Aatresh for additional research and reporting in this article. I’m the founder of SynBioBeta, and some of the companies that I write about—including Mayfield and Mammoth Biosciences—are sponsors of the SynBioBeta conference and weekly digest — here’s the full list of SynBioBeta sponsors.