Dive Brief:

• Visby Medical announced Wednesday it has received FDA emergency use authorization for its single-use, rapid point-of-care COVID-19 polymerase chain reaction test. 
• Visby's PCR test, which provides results in 30 minutes and is performed without the need for additional instruments or readers, is authorized for point-of-care use by organizations with a Clinical Laboratory Improvement Amendments certificate of waiver. FDA in September provided the San Jose-based diagnostic company with an EUA for the single-use rapid PCR test, but at the time it was only authorized in moderate complexity CLIA certified laboratory settings.    
• FDA in late March issued an EUA for Abbott's portable point-of-care ID Now molecular diagnostic. While the Abbott machine provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge. Visby contends its palm-sized PCR test requires only a power plug to operate.      

Dive Insight:

As the U.S. continues to face a chronic shortage of COVID-19 tests, widespread use of rapid point-of-care testing is seen as crucial for slowing the spread of the coronavirus. Both Abbott's ID Now and Visby's Personal PCR test are EUA-authorized molecular diagnostics, which can be used in CLIA-waived settings.

While companies such as Abbott, BD, and Quidel have ramped up production of rapid POC and at-home antigen tests to try to meet the need for massive testing, PCR testing has long been considered the "gold standard" for its high level of sensitivity. The challenge has been getting time-consuming, lab-based PCR tests out of the laboratory.

When it comes to portable testing, Abbott claims its toaster-sized ID Now machine weighing 6.6 pounds is one of the most widely-available molecular point-of-care testing technologies in use in the U.S.

Visby contends it has shrunk rapid PCR technology down to palm-sized dimensions while eliminating the need for an additional instrument or reader.

However, these tests are unlikely to be the "game-changers" that some public health experts have called for — namely, complete self-testing that Americans can routinely perform at home without a prescription.

Toward that end, President Biden has called for a mix of "next-generation" coronavirus testing, including at-home tests and rapid POC tests, and the goal of scaling up our test capacity by orders of magnitude.  

The Biden administration last week awarded $231.8 million to Australia's Ellume to boost U.S. production of a rapid at-home test for COVID-19. The contract includes the purchase of 8.5 million over-the-counter, 15-minute antigen tests for nationwide distribution as part of President Joe Biden's pandemic response effort. Some have called that test too pricey and complicated, though.

The administration also announced it intends to award contracts to six other diagnostics companies to expand production of 61 million rapid point-of-care or at-home tests by the end of the summer. While many public health experts are encouraged by the administration's emphasis on COVID-19 testing, some are concerned the White House is moving too slowly.

For its part, Visby says it is ramping up production of its point-of-care PCR diagnostic, with plans to eventually provide the test over-the-counter for at-home use. Currently, the company is producing tens of thousands of tests per month and is "rapidly trending to hundreds of thousands." 

The company in October received $10 million in funding from NIH as part of the agency’s Rapid Acceleration of Diagnostics (RADx) program, an initiative that aims to increase U.S. national testing capacity for COVID-19. Visby is using the funds to help secure its supplier base and implement automation to scale up manufacturing.

Visby last week announced it received a $12.3 million award from the Biomedical Advanced Research and Development Authority to speed development of its single-use, rapid PCR test for influenza and COVID-19.