An Interview with Dr. Dana Owens, MD, P23 Labs Founding Medical Advisor: ‘Remaining Committed to the Research and Validation of Assays for COVID-19 Further Enables our Goals’

“At P23 Labs, we have our custom built laboratory information management system (LIMS), which helps us control and retain data, results management, and much more.” 

P23 Labs is a high-complexity molecular diagnostics laboratory that specializes in diagnostic testing of infectious diseases. It offers a full suite of molecular diagnostic tests that also include COVID-19. P23 has created a quality laboratory that focuses on fortifying the relationship between patients and providers by removing healthcare barriers.

P23 was incorporated in 2019 and is based in Little Rock, Arkansas. It has an additional laboratory located in Savannah, Georgia.

Dr. Dana L. Owens, MD, FACOG, P23 Labs Founding Medical Advisor, spoke exclusively to The Silicon Review. Below is an excerpt.

Q. Explain your healthcare services in brief:

P23 Labs is a high-complexity molecular diagnostics laboratory that specializes in preventative, diagnostic testing of infectious disease. We offer a full suite of molecular diagnostic tests, most commonly known as PCR testing, for bacteria and viruses, including COVID-19, respiratory pathogen profiles, and other infectious diseases, rapidly identified via our state-of-the-art molecular methods.

Q. What are the defined standards that are set to evaluate the high performance of your product/services?

There are intense quality controlling regulations that our laboratory must follow. Federal, state, and local governments each have their standards. Federal government standards regulate our testing processes and the testing environment. State standards determine the personnel we employ based on skillset and experience.

Q. Tell us about your compliance and regulatory system.

We developed our standard operating procedures to encompass everything from test shipping, specimen receipt and handling, assay performance, and data management. At P23 Labs, we have our laboratory information management system (LIMS), which helps us control and retain data, results management, and much more.

Q. Tell us in brief about your Covid-19 kit and its implications. What is your contribution to fighting against the deadly disease?

Our non-invasive saliva-based COVID-19 kit is available for use at home. It can be administered with telemedical assistance or unsupervised. P23 Labs is the second laboratory in the USA to receive an Emergency Use Authorization (EUA) from the FDA for this specific kind of test, benefits of which include a noninvasive testing method – it’s much more comfortable than the nasal swab. It also lessens the spread of COVID-19 as the user can order the test to their home, collect their specimen, and ship it back to us without leaving.

Being the second laboratory to receive the EUA meant that we were more immediately ready to help companies and individuals test for COVID-19 and begin limiting the spread sooner, with a quicker turnaround of results.

Q. Is P23 Labs working towards innovative, cost-effective solutions for improved lab sustainability?

Our goal is to validate tests in a way that is more cost-efficient and scalable. We want to test more people at a lower price with a quick turnaround time, bringing testing to a broader market and more accessible to everyone. We remain committed to the research and validation of assays for COVID-19 while further enabling our goals.

Q. Mention some of the prominent achievements of your company.

We are very proud that we are the second laboratory in the USA to receive the EUA from the FDA for our saliva-based COVID-19 test. We are the first laboratory to receive an EUA for unsupervised saliva testing at home. We are the only laboratory to receive the EUA for unsupervised at-home testing for our COVID-19 test kit, the Everlywell test kit, and the binx healthcare test kit. We are also the only laboratory in the USA approved for testing at Costco, which is in a partnership with AZOVA.

Needless to say, we are a fast-paced laboratory with efficiencies that allow us to specialize in COVID-19 testing and produce large volumes of results in a desirable timeframe for our clients.

Q. What does the future hold for P23 and its employees? Are exciting things on the way?

P23 Labs is in a considerable growth phase, and we are set to expand in 2021. We will have tremendous growth opportunities for our employees, including incentives, benefits and vesting options, personal and professional development opportunities. Our business’s success depends on our people, and we want to ensure our people remain successful and happy in their endeavors.

Q. Do you have any new services ready to be launched?

We have recently launched our new product P23 Respiratory ONE. This is a test to detect respiratory illnesses that share symptoms with COVID-19 when test results for COVID-19 are negative, and the patient is still not healthy. This test can detect the common cold, five different influenza strains, and five coronavirus strains, including COVID-19.

P23 Respiratory ONE takes your single COVID-19 sample submitted to P23 Labs, whether it was the non-invasive saliva specimen or a nasal swab test, and rules out other illnesses by testing a single sample across multiple assays.

“We are a fast-paced laboratory with efficiencies that allow us to specialize in COVID-19 testing and produce large volumes of results in a desirable timeframe for our clients.”