ARCpoint Labs of Monterey Bay Introduces Lab-Based COVID-19 Antibody Test

1. ARCpoint Labs of Monterey Bay Introduces Lab- Based COVID-19 Antibody Test The test marks a step forward in COVID-19 research; reveals whether asymptomatic patients have already been infected, suggesting potential immunity Monterey, CA, April 20, 2020 —ARCpoint Labs of Monterey Bay, one of more than 100 diagnostic testing lab franchises across the U.S., has announced a new lab-based COVID-19 antibody test that could change the way people and businesses are reacting to the pandemic, providing a path toward normalcy for Americans. ARCpoint Labs of Monterey Bay is offering up to 90 appointments per day to members of the public starting April 20th, available via the website labtestmonterey.com. “We won't be able to do the finger-stick version of the antibody test any longer, but we switched to a version of the test that uses a whole tube of blood from the arm, is more accurate and sophisticated, has earlier detection, and is considered by doctors and health professionals to be a big step forward in medical usefulness,” said ARCpoint of Monterey Bay co-owner and lab director Spenser Smith. “This test is a new and improved version that we are rolling out to continue our embrace of the newest testing technologies for COVID-19.” Smith said the downside of the new tests is that it takes longer to perform, can’t be done in a drive- through setting and is more expensive, at $150 as opposed to the $68.31 cost of the finger-prick test cost. But the arm-draw test is more reliable and sophisticated and has shown to be more accurate than the finger-prick tests, which was rushed into service nationally and has shown to have a high rate of inaccuracy compared to the arm-draw tests. In mid-March, the FDA issued a policy that allowed for manufacturers and laboratories to create, distribute and use rapid serological (antibody) tests without requiring an Emergency Use Authorization to allow more people to have access to tests amid the pandemic. ARCpoint began using point-of-care tests that gave results within 10 minutes, to great success in its franchised locations across the U.S., including the Monterey lab. On or around April 8, however, the FDA added additional clarification to the policy, requiring tests to be performed in high-complexity labs. This new wrinkle led ARCpoint to partner with Access Medical, a high-complexity laboratory, to offer a lab-based serological test as part of its ongoing effort to expand access to the most innovative COVID-19 testing available. The test, which detects SAR-CoV-2 antibodies — specialized immune proteins the body produces in reaction to the COVID-19 virus — may reveal whether or not an asymptomatic individual has already been infected with the virus.

2. For the vast majority of viruses, antibodies signal immunity, meaning asymptomatic individuals who test positive are likely resistant to or functionally immune to the novel coronavirus. As research continues and access to testing improves, public health authorities expect reliable antibody testing to be a key part of recovering from the COVID-19 pandemic. By confirming the presence of antibodies in some individuals, the test can restore confidence and provide relief for Americans whose lives have been upended by social-distancing measures. Crucially, it will also provide a tool for businesses —particularly those businesses deemed “essential,” whose employees regularly interact with potential carriers like healthcare workers and grocery store employees — to minimize risk for employees at work. “This could be a major development in terms of understanding how widespread this disease has actually been,” said Dr. Chris Cherubino, Medical Director for ARCpoint Franchise Group. “Because we currently have no idea how many people may have recovered from and be immune to the virus, everyone is forced to take the strictest precautions; as a result, much of the country has been shut down. By providing antibody tests, we can begin to build a body of evidence and hopefully restore some measure of normalcy for people and businesses as the fight to contain the coronavirus continues.” These high-complexity immunoassay antibody tests require a simple blood draw; samples are submitted to a lab for analysis and returned in two to five days. Beyond the result for the consumer, these lab- based tests make a greater impact in the fight against COVID-19 because blood samples and results are reviewed by scientists, who can use the data to guide future research. In an effort to bring the test to a diverse group of people in the local communities it serves, ARCpoint labs of Monterey Bay is beginning to offer appointments for this test to members of the public via an online appointment-making website, located at labtestmonterey.com. The lab is also able to make arrangements with critical businesses, first responding agencies, and other organizations to test staff directly during onsite or exclusive testing events. “Because this is a new virus, regulations are constantly changing, and ARCpoint is adapting to those changes to provide the best testing solutions in real time. If and when the FDA begins issuing EUAs for the rapid point-of-care serological tests, we will offer them again, but are currently focusing our efforts on the lab-based tests so as to not leave our franchisees and their communities without a solution,” said John Constantine, President and CEO of ARCpoint Franchise Group. “As a country, we don’t have access to good statistical information about how widespread the virus is. The more tests that can be conducted, the better that data will be. The better the data, the better decision-making can happen at a local and federal level. Our antibody test will provide a glimpse into the full scope of this virus. We are working with partners who are developing a quantitative test that will indicate how much of the antibody is present in a large sample of individuals, which will help guide future research of how we treat and prevent this virus.”

3. Dr. Cherubino adds, “It is very important to understand that this test will not tell you if you have the virus currently. This test is only to determine if you may have had the virus in the past and have recovered.” With 100 locations across the U.S., each with the capacity to administer several dozen tests per day, ARCpoint Labs will be able to reach a wide swath of patients quickly. “In a crisis of this magnitude, there is not going to be a single solution that suddenly brings everything back to normal. Still, it’s hard to overstate the impact this test may have in terms of allowing people to get back into the world and providing crucial insights into the nature of the virus,” Constantine said. “We are proud to be one of the first to introduce this kind of test widely in the U.S., but mostly we are just excited to play a small role in providing the first step in getting some relief in this difficult chapter.” MEDIA CONTACT: Marci Bracco Cain, (831) 747-7455 Media note: ARCpoint Co-Owner and Labs Lab Director Spenser Smith is available for media interviews. Please contact Marci Bracco Cain at (831) 747-7455 to set up an interview. ABOUT ARCPOINT LABS ARCpoint Labs is a full-service national third-party provider/administrator of accurate, reliable, and confidential diagnostic testing for individuals, companies, and legal and healthcare professionals. ARCpoint Labs has been in the drug and alcohol testing business for over 18 years, and our staff has over 60 years of combined industry experience. ARCpoint Labs has over 100 locations across the country with an additional 18 locations slated to open within the next 12 months. For more information on ARCpoint Labs, visit www.arcpointlabs.com. ARCpoint Labs of Monterey Bay 24560 Silver Cloud Court, #103 Monterey, CA 93940 Phone: (831) 324-0772 Email: Website: www.arcpointlabs.com COVID-19 Appointments: labtestmonterey.com Contact: Marci Bracco Cain Chatterbox PR Salinas, CA 93901 (831) 747-7455 http://www.arcpointlabs.com