Medical-device maker Abbott Laboratories is rolling out a new desktop device that can detect coronavirus in five minutes in many cases without a patient leaving the doctor’s office.
Abbott’s new test for detecting the novel coronavirus that causes COVID-19 runs inside a toaster-sized analyzer called the “ID Now” that is already in use in many doctor’s offices, hospitals and urgent-care clinics. In March, Abbott announced availability of a new test that can detect the virus using larger laboratory-based analyzers.
Between the two, Illinois-based Abbott said it expects to produce about 5 million COVID-19 tests per month, including 50,000 ID Now tests per day. Abbott is among the array of biomedical companies with major work forces in Minnesota whose systems are being used on the front lines of the global coronavirus outbreak.
Minneapolis-based Bio-Techne is making analyzers to enable researchers to detect when a patient is having a medical emergency related to COVID-19. Eden Prairie-based CHF Solutions is shipping a device that removes excess fluids from intensive-care patients treated for COVID-19. National attention has fixed on Medtronic and its Puritan Bennett ventilators that supply oxygen to fluid-overloaded patients.
At the same time, some companies’ products are seeing declines, like spinal-repair devices and products used mainly in nonemergency surgeries.
“Market demands, potential staffing needs and other business considerations are extremely fluid,” said Shaye Mandle, chief executive of the Golden Valley-based health technology trade group Medical Alley Association, via e-mail. “Some companies are seeing order increases for a particular product that are unprecedented; others are grappling with challenging business interruptions and an unpredictable timetable for their resolution.”
The U.S. Food and Drug Administration (FDA) has been unusually willing to allow diagnostic tests onto the U.S. market quickly by granting what’s called Emergency Use Authorization, or EUA, to products that could be useful in the pandemic.
The status means the device has not been cleared through the FDA’s normal processes, and the marketing authorization may end when the emergency does.
As of Tuesday, the FDA has granted at least 19 emergency authorizations for COVID-19 detection tests, including five this week, according to Divyaa Ravishankar, Minneapolis-based global product marketing manager for in vitro diagnostics at medical research organization NAMSA.
“So far, hundreds of thousands of COVID-19 tests have been performed. Millions are now available, including several point-of-care tests that provide results in under an hour, and one that takes just five minutes,” said Scott Whitaker, CEO of Washington med-tech trade group AdvaMed. “By mid-April, monthly capacity for commercial COVID-19 tests will be in the tens of millions.”
Abbott’s mobile testing system — which appears to be the fastest test on the U.S. market today — works by detecting and amplifying genetic snippets of the SARS-CoV-2 virus that causes COVID-19 in a patient specimen. President Donald Trump displayed an Abbott device Monday during a COVID-19 briefing in the Rose Garden at the White House.
Point-of-care devices are seen as a way to expand and speed up screening for COVID-19, because results can be returned within minutes, and they work in locations without easy access to a major laboratory.
Abbott said its device can produce a positive result in as little as five minutes and a negative result in 13.
The device’s instructions say positive results indicate the presence of viral genetic material, but negative results do not necessarily preclude a SARS-CoV-2 infection. During product evaluation, the device produced the expected result 100% of the time, the instructions say, but the product will continue to be evaluated in the field.
On Wednesday, Abbott is expected to begin shipping 50,000 ID Now tests per day for COVID-19. The company is working with the Trump Administration to deploy the devices where they will have the greatest effect.
“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” Abbott President Robert B. Ford said in a March 27 news release about the device.