What Does It Take to Develop Cutting-Edge Diagnostics?

Aric Joneja, PhD, didn’t set out to work on point-of-care diagnostics, a field in which he has worked for more than 10 years: “I was originally planning to major in aerospace engineering,” says Joneja, now director at Sherlock Biosciences, a Massachusetts-based diagnostics company leveraging CRISPR technology.

A seminar on the origins of life during his undergraduate degree at the University of Maryland College Park changed how he felt about biology, and he decided to pursue a degree in bioengineering instead. This path led him to graduate school, where he worked in a genomics and DNA sequencing lab. There, he witnessed the field grow from a “single chemistry and just a couple of companies” to the booming industry it is today, something that Joneja found exhilarating.

During graduate school, he developed a device for preparing DNA libraries for long-read sequencing, which he eventually commercialized with the company Diagenode under the name Megaruptor. 

Being able to design something that enabled further discoveries continued to spark his curiosity in the field of assay development and diagnostics. “It’s gratifying to see the device help researchers, and even now I continue to get Google Scholar alerts when scientists use it to sequence organisms for the first time,” says Joneja.

Motivated by seeing the real-world impact assays can have in discovery, he decided to pursue developing point-of-care diagnostics at a company called Alere, later acquired by Abbott.

Developing diagnostics to advance health

At Alere, he worked on establishing what is now known as the ID NOW platform, a molecular point-of-care platform originally named Alere^TM i, which was the first molecular point-of-care flu test to receive CLIA (Clinical Laboratory Improvement Amendments) certification for influenza A and B.¹ The ID NOW COVID-19 2.0 assay has also received the U.S. FDA Emergency Use Authorization for detecting SARS-CoV-2.²

“The sensitivity of its influenza, RSV, and strep throat assays are far superior to the antigen tests that were previously used in doctor's offices and clinics,” says Joneja of the significance of the assay. 

The importance of being able to quickly and accurately identify pathogens has certainly been highlighted during the COVID-19 pandemic. The surge in viral respiratory illness that spiked last fall in the US and Canada also emphasized the demand for at-home diagnostics.

“The COVID-19 assay that was released in March 2021 was one of the first point-of-care tests of any kind to be approved and made available to the public, enabling population screening for the virus,” says Joneja, regarding the ID NOW’s EUA.

“Develop your technical skills and hone your problem-solving abilities, but also look for opportunities to take on leadership roles.”

Clinically, respiratory illnesses are often treated the same way, but people usually want to know what is causing their illness for peace of mind and to take necessary precautions. Joneja understood that need. 

“It really surprised me that at-home testing wasn’t more popular before the pandemic, but obviously the market dynamic has changed,” he says.

So, when Sherlock Biosciences approached him about developing molecular diagnostics solutions to enable people to directly access information about their health, he was immediately drawn to the role.

“What drew me here was the promise of developing a low-cost, simple, accurate diagnostic,” says Joneja, about working at Sherlock Biosciences. Such a feat is anything but simple.

The challenges and rewards of assay development

“There are always technical problems to be solved,” he says, “that never goes away, and it is actually part of the fun,” alluding to the nature of scientific research. 

Industry demands complicate technical problems further. Sherlock Biosciences is a rapidly growing company in a highly competitive field. The company was founded in 2019, and it was only a year later that its CRISPR technology became the first to be FDA-authorized for emergency use.³

Thus, while juggling technical problems, and keeping up with the literature, Joneja must routinely assess the risk and reward of ongoing projects, and their pipelines to allocate resources efficiently. 

“The pace of research on new molecular diagnostic platforms has been frantic, and we want to be sure that our solutions are differentiated from anything else on the market.” 

Embracing soft skills along with pure science

All these hurdles could not be overcome without communication, a skill that Joneja deems essential as a research director: “Many scientists tend to be very data-driven and detailed in their communication,” he says, but “you have to be able to step out of your bubble and distill information.”

“Communication such as knowledge translation, digesting complex data and information, as well as market research, are important skills.”

Aspects of communication such as knowledge translation, digesting complex data and information, as well as market research, are important skills that Joneja says are essential in an industry with ever-shifting priorities and markets.

Soft skills like communication are not usually prioritized in academia: “The overarching theme is that people achieve their degrees within academia and are taught pure science rather than tackling the practical side of the field,” wrote Spicer, Colcomb, and Kraft in their career feature for Nature Biotechnology in 2022.⁴

They point out that many subjects that would benefit a career in industry, including commercialization, economics, compliance, law, intellectual property, basic project management, and networking, are rarely taught in academia. As a result, many PhD students are not prepared for the cross-disciplinary team work found across industry.

“Develop your technical skills and hone your problem-solving abilities, but also look for opportunities to take on leadership roles,” says Joneja. Take the initiative to build rapport and trust with supervisors and colleagues to ensure people see you as someone reliable who can be given more responsibility, he says, which is the key to gaining experience in tackling multiple projects on the go.

But he cautions young trainees in the diagnostics field to start small by leading individuals or small teams of researchers who are less experienced. Drawing from graduate mentoring experiences is key here, he says. 

Don’t underestimate networking

Joneja first became accustomed to networking during his undergraduate degree, when he was part of the Phi Sigma Pi academic honors fraternity at the University of Maryland College Park. 

“Developing diagnostics that provide actionable results so patients can obtain the right treatment faster is what continues to drive me.”

“Being a member of a community made up of people from different backgrounds who shared a common goal of giving back contributed to my outlook on the importance of reaching out to others and building long-lasting connections,” he says, and these connections are pivotal in the diagnostics field<em dash>networking has not only been beneficial to his career but also to his development as a diagnostics researcher.

Joneja recommends that early-career industry researchers reach out to mentors and/or role models in positions of interest for career advice and inspiration: After all, developing diagnostics that provide actionable results so patients can obtain the right treatment faster is what continues to drive me, says Joneja.

References:

1. Alere Receives FDA CLIA Waiver for Alere™ i Influenza A & B Test. Alere, Inc. January 7, 2015. PRNewswire.com. https://www.prnewswire.com/news-releases/alere-receives-fda-clia-waiver-for-alere-i-influenza-a--b-test-300016944.html.
2. U.S. Food and Drug Administration. ID NOW COVID-19 2.0 – Letter of Authorization. May 6, 2022. https://www.fda.gov/media/158399/download.
3. Jennings K. FDA Authorizes First-Ever Crispr Application For COVID-19 Coronavirus Test. Forbes. Published May 7, 2020. https://www.forbes.com/sites/katiejennings/2020/05/07/fda-authorizes-first-ever-crispr-application-for-covid-19-coronavirus-test/.
4. Spicer AJ et al. Mind the gap: closing the growing chasm between academia and industry. Nat Biotechnol. 2022;40(11):1693–1696. doi:10.1038/s41587-022-01543-4.