Inside a cavernous building not far from Goleta City Hall, three UC Santa Barbara graduates are heading up a company that is developing a saliva-based test system for COVID-19 that could significantly boost the ability to quickly diagnose the disease — handling thousands of samples daily with same-day turn-around.
“Our goal is to offer this in a manner that provides rapid turn-around and ease of use, but that also is appropriately economical, so that it’s reasonably accessible to folks,” Scott Ferguson, CEO of Aptitude Medical Systems, told Noozhawk.
Aptitude Medical was founded in 2011 by Ferguson, chief operating officer Qiang “Jackson” Gong and chief science officer Jinpeng “JP” Wang. All three are graduates of doctoral programs at UCSB.
Prior to the coronavirus pandemic, the company was developing medical tests and treatments focused on nucleic acids — notably RNA.
“We started a company on the back of the ability to exploit nucleic acids to make molecules for different purposes,” Ferguson said, adding that Aptitude is focused on both diagnostic and therapeutic applications.
“Then COVID came along, and we thought, ‘Oh my God, there’s this need to do testing for COVID, and the traditional paradigm for testing sucks, in terms of lots of delays’ …,” Ferguson said. “So we felt there is really a broad need — to be able to contain this virus — to have lots of testing done frequently, and get the results back quickly.
“And so we looked at this from the perspective of, OK, here’s a very acute, broad problem, do we have a way to address this by leveraging stuff we’re already really good at?”
Testing emerged early on as one of the key challenges in responding to the novel coronavirus, with what is known as the PCR nasal swab quickly becoming the standard.
The PCR test is an accurate and effective means of detecting an active COVID-19 infection in both symptomatic and asymptomatic patients. Early on in the pandemic, it was taking up to a week or more to get results, severely reducing its effectiveness in battling the rapid spread of the disease.
The PCR — short for polymerase chain reaction — involves collecting respiratory material from the patient’s nose using a swab on a long, slender stick. For those who have endured the probing, it’s typically more uncomfortable than painful.
Once the sample is obtained, it is sent off to a lab, where it is run through a lengthy process using chemicals and machinery to determine the absence or presence of the novel coronavirus, which can cause COVID-19. Most results now come back in a day or two.
With the system developed by Aptitude, that process has been compressed to about 90 minutes, and it can be run at a scale that could handle 8,000 to 10,000 tests per day with the equipment the company already has developed. There is potential to scale up even more, Ferguson said.
That could be a huge benefit for schools, businesses and other entities that are trying to return to normal operations while keeping students and employees safe.
The process for Aptitude’s test has patients spit into a small vial using a specially designed funnel, then seal up the container, which contains a unique bar code and QR symbol that can be tracked using an app developed by the company.
The company can process the samples in lots of about 100 at its CLIA-certified laboratory, using special tools it developed to make the process extremely efficient.
So how accurate is Aptitude’s saliva test compared to the widely used PCR test?
Ferguson said a side-by-side study of the two found the results were “comparable” — “100 percent agreement of positives and negatives.”
Companies can voluntarily get an Emergency Use Authorization (EUA) for a test like the one Aptitude developed, Ferguson said, but he added that the Food & Drug Administration is not specifically requiring one for those developed in a CLIA-certified lab.
“We’re licensed to execute these tests,” he said. “We meet state and federal standards.”
The last step for the company is bringing its test system into use in the community.
Aptitude worked with a university on a pilot project for the tests,“which went very well,” and has expanded into a regular testing program.
Ferguson said the company is contractually obligated not to disclose the name of the university, but the UCSB Student Health Department notes on its website that it is using the Aptitude saliva tests.
Aptitude also has set up a retail operation, with a collection site at Earl Warren Showgrounds in Santa Barbara.
The cost is $149 per test, and the company currently is offering a 20 percent discount, bringing the price tag to $119. Click here to schedule an appointment online.
Aptitude also is offering institutional testing for businesses, schools and other organizations, with the cost “significantly reduced” depending on factors such as test numbers and IT support, Ferguson said.
“We are currently in advanced talks with several enterprise customers,” he said. “We expect to reach a throughput of several thousand tests per week in the near future, which will make us by far the largest local provider for rapid and highly sensitive COVID-19 molecular testing.”
A key question for many people about the Aptitude test is whether it will be covered by health insurance, since the price point may be daunting, even with the discount.
“We are committed to making our tests affordable and rapidly available to support the community,” Ferguson said. “To this end, we are also working with insurance companies so that we can offer same-day testing to the local community with no out-of-pocket expense.
“We are already making progress with Medicare and HRSA (the federal Health Resources and Services Administration that covers the testing cost for the uninsured), and are working to officially roll out the insurance payment option in the future.”
A final question is about the long-term need for mass testing for COVID-19, given that more and more people are being vaccinated, with the likelihood that the local community, along with the state and nation, will eventually reach a level of herd immunity.
“No vaccines are 100 percent protective, and new virus variants are emerging, which render vaccines even less effective,” Ferguson noted. “On the other hand, as the state and the county loosens up restrictions and people start going back to schools and workplaces, the chance of exposure will rise significantly.
“The expert consensus is that COVID-19 cases will persist at a lower level but for a long time. This low-level, sustained threat is particularly difficult to deal with — the occurrence will be too low to justify the maintenance of a costly testing infrastructure; however, a surprise spread of a new variant will be deadly and any new cases still need to be promptly identified and managed to safeguard the community.
“Because of these considerations, we believe our affordable same-day COVID-19 testing fulfills an important public health need for the foreseeable future.”
— Noozhawk executive editor Tom Bolton can be reached at tbolton@noozhawk.com. Follow Noozhawk on Twitter: @noozhawk, @NoozhawkNews and @NoozhawkBiz. Connect with Noozhawk on Facebook.