Cambridge biotech seeks OK for coronavirus test that delivers results in 15 minutes

Researchers at Mass. General are ‘cautiously optimistic’ that the product, which resembles a pregnancy test, is reliable.

A diagnostic test for COVID-19 that resembles an over-the-counter pregnancy test and can deliver results in about 15 minutes.

A Cambridge biotech founded by researchers from MIT and Harvard University has developed a diagnostic test for COVID-19 that resembles an over-the-counter pregnancy test and delivers results in about 15 minutes.

If the product made by E25Bio is reliable, it could make testing simple and faster, and ease the shortage of tests that public health officials say has accelerated the spread of disease in the United States. With testing so limited and slow, they say, many people unknowingly may have infected others, making containment more difficult.

Massachusetts General Hospital researchers have tested the product over the past two weeks on 50 patients who provided nasal swabs for the standard PCR, or polymerase chain reaction, test. That test typically provides results to patients within 24 hours.

“Preliminary data looks very exciting,” said Dr. John Iafrate, vice chairman of the hospital’s pathology department, which is running the comparison. “We still do not know if the sensitivity of detection is as good as the PCR-based assays, and that’s a critical caveat."

Although Iafrate declined to share specific data, he said he was “cautiously optimistic” that the initial results will help E25Bio obtain an emergency use authorization from the federal government to deploy the test at hospitals and in doctors’ offices.

Mass. General, he said, plans to run the test on swabs from another 100 patients and should have final results in about a week. Researchers at the teaching hospital are validating the new test as a public service, and it is not receiving any royalties or payment.

Irene Bosch, an MIT research scientist and adjunct professor of medicine at New York’s Mount Sinai School of Medicine who helped found E25Bio, said she has been in constant contact with the Food and Drug Administration. Bosch said she expects that the emergency use authorization will be “coming very soon.”

“We’re ready to submit all of the data,” she said. Her firm hopes to sell each test for $10, she said, and has a manufacturing organization in Massachusetts ready to make them. E25Bio documents say more than 100,000 tests could be manufactured daily.

The big advantage of the test over the standard one, Bosch said, is that it is cheaper, simpler, and faster, enabling doctors to “separate the infected individual right away” from other people who could catch the virus.

She said Brigham and Women’s Hospital also plans to study the E25Bio test.

Although the test looks like a pregnancy test sold at a CVS or Walgreens, it would initially be marketed for use only by health care providers at a hospital or doctor’s office.

Dr. David Louis, head of Mass. General’s pathology department, said a key reason not to sell it over the counter is that it’s imperative that doctors share the results of any test with state public health authorities, who are tracking the number and distribution of coronavirus cases.

“Having tests out there that aren’t connected to a reporting structure is dangerous,” Louis said.

Founded in 2018 with funding from MIT’s The Engine, which invests in early-stage startups, E25Bio has developed rapid tests for viruses that cause dengue fever, Zika, and chikungunya disease. The company scrambled to begin developing a test for the coronavirus in early February, according to Bosch.

The standard PCR test works by searching for evidence of the virus’s RNA genome. E25Bio’s test works differently, using nanoparticle technology to capture virus and viral proteins in mucus, saliva, blood, and urine, said Bosch. The test is called Spike Dart, for Direct Antigen Rapid Test, Bosch said. Similar to a pregnancy test, it displays two red stripes if a patient tests positive for coronavirus.

E25Bio is hardly the only company working on coronavirus tests that can deliver rapid results.

Scanwell Health, an at-home test company based in Los Angeles, has licensed the rights to a test developed by the Chinese company Innovita, which was widely used at the height of that country’s epidemic earlier this year.

That test requires a drop of blood from a pin prick and also provides results in about 15 minutes, according to Jack Jeng, its chief medical officer. Scanwell hopes to obtain an emergency use authorization from the FDA in five to seven weeks.

Mass. General’s pathology department is also testing experimental products from a handful of domestic and foreign companies aimed at determining whether patients have antibodies after having been infected with the coronavirus, according to Louis and Iafrate, the pathologists.

Those antibodies would potentially make them immune to reinfection, possibly for years. Antibodies could have been developed in patients who had mild cases of the disease or didn’t even know they were infected, they said.

An antibodies test could be a powerful tool, they said, because it would help researchers determine how widespread the epidemic is. Such a test also could identify health care providers who are immune to the disease and can treat coronavirus patients without fear of getting infected themselves.