Pitkin County placed an order for 1,000 COVID-19 tests from Colorado-based startup Aytu Bioscience on Wednesday. The county does not yet have an estimated date for when the tests will arrive, nor does it have a formal plan for who is eligible to be tested.
The “serological tests” use a drop of blood from a finger prick and can produce a result in less than 10 minutes. They test for COVID-19 antibodies, which the human body creates to fight the virus. This means blood tests can identify patients who have had COVID-19 in the past, even if they never showed symptoms.
Gabe Muething of the Pitkin County Incident Management Team explained why the county is seeking out those blood tests in a video.
Samples do not have to be sent to an off-site laboratory for processing, like nasal swab tests. Nasal swab tests can also often cause the patient to cough or sneeze, which means that test conductors have to frequently change personal protective equipment, or PPE, to avoid gathering airborne particles. The blood tests would require the use of less PPE, which is in short supply.
Aytu CEO Josh Disbrow said the company only recently started selling COVID-19 tests, which have been in high demand.
“We were not in the COVID business, so to say,” Disbrow said. “We have had to call a bit of an audible, and it's enabled us to actually broaden our distribution reach. We had not been previously calling on municipalities, state governments, first responders and so forth. We also have orders from corporations that we hadn't previously dealt with.”
Aytu, which is based in Englewood, Colo., works with a company in Hong Kong to acquire tests developed in China, which are then imported and sold in the U.S. The tests are not approved by the Food and Drug Administration, or FDA, in the traditional sense. Instead, the FDA allows their sale under an “emergency use authorization” process.
“There is a very efficient, very fast process that the FDA has put in place given the urgency and the need to get these tests out there,” Disbrow said. “During the crisis and during this emergency state, these tests will be allowed to be distributed on the market with the proviso that the manufacturer has sufficiently validated the test results.”
Disbrow said the demand has stretched Aytu’s small team.
“We get more emails in an hour than we would get in an entire week prior to this announcement, Disbrow said. “We're a small company. We have a small staff. While we do have 80 employees, most of those folks are sales representatives that are out across the country. So in terms of the operational fulfillment, it's a relatively small crew."
Aytu is in the process of distributing its initial stock of 100,000 tests and expects high demand for its next shipment of 500,000.