Fortune Fortune
My Account Log Out

How Roche’s new coronavirus test sped its way to FDA authorization

Roche has the first commercially available diagnostic test for COVID-19.

Subscribe to Fortune’s Outbreak newsletter for a daily roundup of stories on the coronavirus outbreak and its impact on global business.

Private firms are stepping up to fill a hole in coronavirus testing that federal authorities, to date, have been unable to fill. And Roche’s diagnostics arm claimed one of the most significant advances this week.

The Food and Drug Administration (FDA) late Thursday announced a pair of new measures meant to spur coronavirus testing in the U.S.—an important public health response which has suffered from a series of manufacturing, regulatory, and political setbacks.

Both of the FDA’s actions are “emergency use authorizations” (EUA) of COVID-19 diagnostic tests, one developed by New York state and the other by the drug giant Roche. Such an authorization means that certain labs beyond official public health laboratories can conduct such tests.

But what makes Roche’s advance so striking is that it is, per the FDA, the “first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak.”

“To expedite access to this test, FDA did not object to Roche pre-positioning its test so that labs could be ready to initiate testing immediately upon authorization of the EUA,” the agency wrote in a statement. “Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.”

Multiple Roche spokespeople told Fortune that they expect this specific diagnostic could fuel 400,000 tests per week—and that they could start being deployed within 24 hours.

Unlike with public health laboratories, which largely conduct CDC-cleared tests, Roche’s commercial test can be used with dozens of other labs across the country. These are a mixture of 32 regional laboratories and so-called “reference laboratories”—facilities which can receive a biological specimen from a different lab to conduct a specialized test.

This, according to Roche, is what could fuel a dramatic increase in testing. “We’re being very strategic about where we’re deploying the test,” a Roche spokesperson told Fortune. “We’re working very closely with the CDC to prioritize labs that have the broadest geographic reach.”

Roche’s test has also advanced on a dramatically fast timeline. “We started to work on developing the test in February,” said Paul Brown, global head of Roche’s molecular department arm and chief of Roche Molecular Solutions. Brown said developing and getting regulatory approval for a new diagnostic usually takes 12 to 18 months, but Roche was able to pull it off in about six weeks.

How? The government was keen to move quickly since it has a dearth of testing options. But Roche’s specific expertise set is also a major component.

“We’re the pioneers behind something called PCR chain technology,” said Brown, referring to a type of biotech that can sniff out various viruses. “We’d been watching what’s been going on and accelerated our organization over here. We kind of put the process on steroids.”

Roche focused on bolstering the company’s manufacturing processes to ensure a mass amount of tests could be created. This additional diagnostic is added to machines already in labs.

With the new test, a patient could theoretically go to a hospital, have nasal and oral swabs collected, and then have those samples shipped over to an affiliated laboratory that can conduct the test.

When it comes to pricing, the situation is far more complicated. Roche declined to comment on the record about how much its test might cost a patient, noting that would depend on what a specific laboratory might charge and the level of health insurance someone has. Roche also declined to comment on exactly which labs are included in the partnership, and how much the company charges labs for the test.

More coronavirus coverage from Fortune:

—How coronavirus is affecting the global concert industry
Politicians around the world are going into quarantine
—Some of the most extreme ways companies are combating coronavirus
—How Europe is adapting to the coronavirus outbreak
—What Xi Jinping’s visit to Wuhan says about China’s coronavirus recovery
Conferences go online amid coronavirus fears—minus the hallway schmoozing
—Coronavirus may not be all bad for tech. Consider the “stay at home” stocks

Subscribe to Fortune’s Outbreak newsletter for a daily roundup of stories on the coronavirus outbreak and its impact on global business.

Subscribe to read more

Already a subscriber?

Join today to get the best of Fortune.

$8/month

Billed annually, cancel anytime.

  • Complete access to Fortune.com and our archive
  • Fortune On Demand: Original video series and exclusive CEO interviews