Rapid PCR Testing Needed as More COVID Variants Emerge

The U.S. is experiencing a decline in COVID-19 testing and vaccinations continue as the emergence of new variants like Delta or Lambda have spurred the need for PCR testing devices.

“Many companies have reported a fall off of testing with an increase of vaccination, but we’re still very much in a space where testing is a necessary part of the overall regime, and I think it’s going to be with us for a while,” said Christopher Jowett, chief commercial officer, Visby Medical, Inc.

Visby Medical’s COVID-19 point of care rapid PCR test, or polymerase chain reaction, is used to detect genetic material from a specific organism. It is the first of its kind to provide fast PCR testing in a miniaturized form through a hand-held device capable of producing test results within 30 minutes. 

The device was approved for emergency use authorization by the Food and Drug Administration in September 2020, and since that time it has been used in multiple event spaces, travel zones, and workplace settings. 

Recently, Premier Labs used the testing regime during the U.S. Olympic Trials for all participants and attendees in track and field. 

The device is also being used by Clarity Labs for testing individuals who want to travel internationally. Clarity has set up a laboratory testing center in Los Angeles International Airport, and the same is happening in multiple airports around the country. 

“The pandemic has created these new and different venues where testing is being employed for the purposes of protecting those individuals, or providing the confidence for those individuals to attend events, to enter workspaces, to travel, etc. Those types of requirements didn’t exist prior to this,” said Jowett. 

To use the device, the person being tested provides registration information like name and birth date and is then handed a self-collected swab device. The individual swabs their nasal cavity from inside the nostrils or further up the cavity, and the swab is put into a buffer tube, and then collected by a medical professional. 

The collected specimen is brought to a testing area under CLIA certified license, also known as a clinical laboratory improvement amendment, which regulates laboratory testing and requires clinical laboratories to be certified by the Center for Medicare and Medicaid Services before any human samples for diagnostic testing can be collected.

The dry reagents inside of the tube are activated by the specimen when a medical professional presses numbers on the side of the device.

Typically, PCR testing in a lab can take anywhere from two to three hours, but Visby’s microfluidic system accelerates the process and results are given to the individual tested within 30 minutes. 

This device is even used in Visby’s own facilities to protect employees against an outbreak, as in November 2020 when their San Jose facility experienced a COVID outbreak, and the device was used to test onsite employees three times a week.

The testing requirement for Visby employees has now been reduced to twice a week, although they are still required to wear face coverings, maintain social distancing measures, and are directed to health care providers if individuals test positive. 

While there is no current vaccine required for Visby employees, this is a common trend in most U.S. workplaces which are not currently requiring employees to be vaccinated prior to returning to in-person work.

According to data from the Society for Human Resource Management only 11% of employers in the U.S. are requiring people to get vaccinated. This makes the need for rapid PCR testing even greater in order to prevent an outbreak and help foster trust with employees who want to feel comfortable and safe in their return to work. 

“We’ve already begun to see the benefits of the ability for the Visby test to be used in rural and underserved communities, and areas where they are a bit more remote and could use a product like this, which does not require an instrument to provide a service,” said Jowett.

Visby Medical recently partnered with Capture Diagnostics in Hawaii to donate tests to the Institute for Human Services. The lab was focused on aiding the homeless in Hawaii and was able to complete testing of the vulnerable population in a timely manner thanks to the donation.

The price of getting a test is determined by the labs who collect the sample, perform the data management, and track that data. Coverage for testing also varies depending on the type of health insurance of the individual seeking testing. 

Although the device is not authorized for use outside of the U.S., Jowett said the manufacturer is prepared to provide evidence to the FDA to ensure the device is capable of detecting all of the variants which may emerge. 

“We are absolutely clear that we detect the delta variant, as well as other known variants, the UK B117, the South African B1351, Brazilian variant P1, and we do verify this by following FDA guidelines which require that we perform periodic bioinformatic analysis for these new sequences which may impact our tests,” said Jowett.

Jowett and the team at Visby Medical are also looking to expand the use of the PCR test to also add flu A and flu B to provide a broader respiratory panel for this product in the future.

“Having been in medical technology and diagnostics for my entire career, what I have seen over the course of the pandemic is an enormous influx of capital and interest in accelerating diagnostic testing innovations to support not only this pandemic, but also future pandemics,” said Jowett.