Renegade.bio, a Berkeley public benefit corporation founded in 2020 to administer Covid tests, has developed a proprietary PCR test for the monkeypox virus and has begun administering the tests locally.
The company already has a contract with the California Department of Public Health to test samples of monkeypox at its lab, but has been developing its own test to be used in detection at the early fever stage of the virus.
Renegade.bio is currently processing tests from 369 people as part of a trial run of its tests. CEO Craig Rouskey expects the test, an oral swab similar to a Covid PCR test, to be more widely available through its partnership with the CDPH and has capacity to test 1,000 samples per day with results in 24 hours.
"We created an assay that allows for earlier detection of the virus and we conducted a study to show that it works on asymptomatic folks," Rouskey said. "The technology is similar to an Covid test, but it's a lot more sensitive in that it can detect 75 copies per milliliter, which is more conducive to early detection."
Monkeypox typically lasts for a 21-day period with the first three days being a fever that eventually disappears and is followed by lesions all across the body. Rouskey said his test is ideal for use during the fever stage so that patients can get the medications they need earlier on in the infection.
“So if you had an unexplained fever that went away, come in and get tested, if you've been around people that contracted the virus or at parties or festivals where people contracted the virus, it's important to come in and get a swab," he said.
The company developed its test in only 20 days and has been able to deploy it immediately because tests developed for use in a single laboratory do not need to be FDA approved if the lab is CLIA certified.
Last week San Francisco declared a public health state of emergency due to rising cases of monkeypox, allowing the local government to allocate more resources and personnel to fight the disease. California has yet to declare a similar emergency. There has so far been 305 cases of the virus detected in San Francisco, 799 in California and 5,189 nationally.
Renegade.bio was founded in 2020 shortly after the start of the pandemic to administer Covid-19 tests as a public benefit corporation with a goal of providing medical services to underserved populations. It currently also provides STD testing for patients using the AIDS pre-exposure drug PrEP who are required to regularly test for sexually transmitted diseases.
The company, with about 100 employees, has raised $1.1 million and is in the process of raising a Series A. Rouskey says the company has generated about $50 million in revenue in its first two years of operations.
"It's really personal for us," Rouskey said. "The founders of this business are all gay men and it was really important for us to respond to this."
The recent spread of monkeypox, which is an endemic in parts of Africa, is said to have started among men who have sex with men, though health officials say it is not sexually transmitted and stress that it can infect any person and impact any community. The World Health Organization has declared it a public health emergency.
