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FDA gives green light to first commercial test for coronavirus

The Roche logo.

(Wikimedia Commons/F. Hoffmann-La Roche, Ltd.)

The U.S. Food and Drug Administration has granted emergency-use authorization to the first commercial test for the virus that causes COVID-19. 

According to a news release, global biotech company Roche will be able to provide millions of tests per month. The new tests utilize nasal and throat swabs from patients who meet the criteria for COVID-19 testing.

The testing machines called cobas 6800 and cobas 8800, can provide 96 test results in three and a half hours. These machines are widely available in the U.S., according to the release. 

It is currently unclear if there are any tests in Indiana, and according to Dr. Dan Handel, chief medical officer for the IU Health South Central Region, there are currently no tests available in Monroe County.  

Indiana’s first presumptive positive case was reported by the state department of health on March 6. One week later, the ISDH has confirmed 12 total cases in the state but only tested 73, according to its website. 

Large-scale testing is a critical part of tracking the spread of infectious diseases and allocating resources for treatment, and the current lack of comprehensive figures means U.S. health providers could quickly be overwhelmed by undetected cases.

Until now the testing process in the U.S. has required mixing various chemicals to set up chain reactions that extract genetic information from patients’ swabs. Each lab must fine-tune the process on its own equipment, something experts have likened to perfecting a new recipe.

Handel says IU Health is working on developing a way to test for the virus on its own to supplement the testing being done by the state. He says he does not know if IU Health hospitals will be using the Roche test. 

Unlike countries with centralized, government-based health care systems, the U.S. response is fragmented between public labs and private efforts by hospitals, universities and diagnostic companies.

AP has contributed to this report

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