As the number of novel coronavirus cases balloons across the globe, public health authorities are racing to speed up the rate of testing after initial lags. Universities, health organizations, and private companies are pursuing better, faster, and cheaper tests that can ease the demand for dwindling resources.
One of those pursuers is the health startup Genalyte. It's harnessed FDA-approved technology honed over the past 13 years and configured it to rapidly test for Covid-19 from a single fingerstick. Its “Maverick Detection System” can deliver results in as little as 15 minutes, company CEO Cary Gunn tells Inverse, and provides insight not only into who has COVID-19, but who might be protected in the future.
“Healthcare systems are going to be able to tell very quickly who has been infected and who is now very likely immune and can go back to work,” Gunn tells Inverse.
The team at Genalyte — which has been described as “like Theranos, but it works” — has been "working 24/7," says Gunn, to create an efficient test. Gunn says they hope to start using it to test patients within days or "a very small number of weeks."
The machine offers serology testing, which analyzes the antibodies in people’s blood samples to capture their immune response to the novel coronavirus.
“Once we are validated, we are going to be able to put it in these drive-through centers and offer same day or next day turnaround time, depending on how much volume we get,” Gunn says. Here, validated means making sure the Covid-19 test actually measures antibodies correcting — and Genalyte is testing samples of patients now.
Mark Slifka, a microbiologist at Oregon Health & Science University, agrees that an effective, efficient serology test would be tremendously helpful in slowing down the pandemic. He is not a part of Genalyte.
“By knowing how many people have been infected so far, we can better estimate the overall mortality rate in different age groups or among different vulnerable populations and adapt our pandemic response plans accordingly,” Slifka explains.
“If a high proportion of a community has become immune to the coronavirus, then this reduces the odds of the pandemic continuing to cycle among that population and reduces the risk of the virus re-emerging later on.”
Currently, most Covid-19 testing relies on using special Q-tips to swab the nose and throat. Then, a technique called reverse transcription-polymerase chain reaction (RT-PCR) helps identify the specific genetic material of SARS-CoV-2 in the samples. These tests capture people’s viral load, but they sometimes miss the mark and cause false negatives, and take days to process.
“We are always able to collect blood so that you never miss the sample, whereas somewhere between 10 and 25 percent of the time, these nasal swabs end up missing the virus even if the patient is positive,” Gunn says.
Serology testing, which is already used in countries like Singapore, offers a quicker, more targeted alternative, Gunn hopes. The approach could help identify people who never showed symptoms, or who were previously infected but aren't currently sick.
"Since the virus is rapidly cleared in most patients, the serology tests are often the most useful for determining what proportion of the population was infected with the coronavirus, especially among those who did not get tested during the early stages of infection," Slifka says.
Every time our immune system meets a viral invader, we develop specific antibodies to fight it, and remember it if we were to face the virus again. Serology testing illuminates if someone has produced these helpful antibodies and mounted an immune response to the virus.
To detect these helpful antibodies, the "Maverick" machine utilizes a little silicon chip, Gunn explains. They place a piece of the novel coronavirus on the chip, and flow the patient's blood over it.
“If they've developed the antibodies, those antibodies will bind to those viral fragments — and we can see that happen,” Gunn says.
The process may sound too good to be true (and perhaps echoes Theranos’ false promises) but Gunn emphasizes that Genalyte has been through rigorous review from regulators. The FDA approved Genalyte’s Maverick testing system in October of last year.
“We've had a robust review and clearance by the appropriate agency," Gunn says. "We're not trying to cut any corners on that front."
Right now, the serology test for COVID-19 is currently being validated. Genalyte has crowdsourced samples from patients with positive COVID-19 tests and is racing to get approval under the FDA's Covid-19 Emergency Use Authorization to start testing patients. They are already talking with health facilities about scaling their operation around the country.
Genalyte isn't the only company offering a rapid, serology test. Biomerica has already started shipping its version — a disposable, single-use serology test — to governments and Ministries of Health around the world. As the pandemic progresses, more companies from Genalyte to AlphaBiolabs are scrambling to get in the testing game.
Still, serology testing isn’t perfect, for a number of reasons. The tests won't be helpful, for example, in determining who is actively contagious, Slifka explains.
"Once the antibody response has been mounted, the virus is usually cleared very quickly after that and then the person is no longer contagious," Slifka says. "For these reasons, we are utilizing the PCR/nucleic acid tests at this time since these are designed to detect the active replication of the coronavirus itself."
Serology testing can also lead to false positives, Slifka cautions.
“We need to make sure that the serology tests are highly specific,” he says. “For example, if the test mistakenly cross-reacts with antibodies mounted against other common coronaviruses then the data will be skewed and inaccurate.”
Likewise, the serology test needs to be highly sensitive, Slifka says, even if people mount a weak antibody response against Covid-19.
If the team at Genalyte can avoid these pitfalls, they hope to test up to 5,000 people daily for Covid-19.
That would be welcome news for the thousands of people feeling Covid-19's hallmark symptoms: fever, shortness of breath, and dry cough, and hoping for a test to give them answers.