The ever-changing SARS-CoV-2 virus requires constant vigilance. As its mutations are studied and better understood, testing needs will continue to evolve, likely well beyond the “end” of the pandemic. Organizations looking to develop SARS-CoV-2 diagnostic tests that help control COVID-19 cases and assess vaccination efforts often need help from a nimble and responsive viral diagnostic test development partner. This additional support enables diagnostic developers to better respond to public-health needs and viral mutations in real time, ensuring comprehensive diagnostic solutions are submitted to the US FDA for Emergency Use Authorization (EUA) and reach the market as quickly as possible.
Researchers pursuing the next generation of COVID-19 diagnostics can benefit from Avomeen’s deep bench of viral and immunological diagnostic expertise. Throughout the pandemic, we have leveraged our long-standing experience in this space to develop a number of COVID-19 diagnostics for various partners. Our purpose-built labs and Ph.D.-led scientific teams stand ready to act as an extension of your team and facility. Additionally, our consultative experts can also provide significant know-how around the changing regulatory landscape and agency guidelines.
A dedicated, consultative team of scientists with a deep understanding of viral and immunological diagnostic test development
Regulatory knowledge and experience needed to support EUA applications with data and documentation
Flexible and customized co-development partnership arrangements and structures to share in the cost of COVID-19 testing platforms
US FDA COVID-19 Emergency Use Authorization (EUA) Laboratory Support
In addition to viral and immunological diagnostic development services, Avomeen can provide the scientific data and regulatory support required to apply for and obtain a diagnostic Emergency Use Authorization from the FDA. The EUA standard requires less evidence than full approval, clearance, or licensing standards, which makes the EUA process unique from traditional FDA diagnostic pathways. Data must show that a product may be effective and that both the known and potential benefits outweigh the known and potential risks. When packaged into a well composed submission, this data can enable the FDA to authorize the emergency use of medical products within days or weeks instead of months or years. According to the FDA, they have currently prioritized the review of EUA requests for:
Tests where authorization would increase testing accessibility, like
- Point-of-care (POC) tests
- Home collection tests
- At-home tests
Tests that would significantly increase testing capacity, like
- Tests that reduce reliance on test supplies
- High-throughput, widely distributed tests
Figure 1. Summary of the FDA’s Process for Emergency Use Authorization (EUA) Issuance
SARS-CoV-2 Testing & Diagnostic Co-Development Opportunities
Avomeen is committed to standing alongside our clients and partners in the fight against COVID-19. As part of this commitment, Avomeen has active co-development projects underway with our partners. If you’re looking for a co-development partner who may share in the cost of your next generation COVID-19 testing platform, connect with us to discuss options for potential co-development arrangements. We are steadfast in our support of clients and partners as they develop solutions to meet public health needs during this unprecedented time. If you have a partnership agreement in mind, we want to hear from you. If not, we will propose our ideas once we talk more.
SARS-CoV-2 Diagnostic Development Expertise
Our scientists have vast experience developing and validating viral diagnostic tests for a wide range of assay applications, including rapid point-of-care (POC), direct to consumer (DTC), at-home testing, over-the-counter (OTC) tests, and traditional clinical lab-based diagnostics. Furthermore, this experience extends to all manner of critical diagnostic formats used during the pandemic, including molecular PCR tests, rapid antigen tests, serology, and neutralizing antibody assays.
Molecular Diagnostic Tests
Molecular diagnostic tests have played a central role in pandemic control strategies, since they can determine if an individual has an active infection, quantify viral load, and indicate when individuals have fully cleared the virus post-recovery. Typically, molecular tests (e.g. Nucleic Acid Amplification Tests or NAATs, such as RT-PCR or droplet digital PCR) detect SARS-CoV-2 RNA in nasopharyngeal secretions and saliva to diagnose infection. These tests are highly sensitive and are able to detect both early and asymptomatic infections.
Among our history of molecular diagnostic projects, Avomeen has significant experience helping local public health organizations develop their own molecular diagnostic tests that detect and quantify SARS-CoV-2 variants. In addition to molecular diagnostic development service experience, Avomeen has been performing PCR-based COVID-19 tests for many months of the pandemic. This hands-on test execution further helps us understand the key considerations for designing optimal tests.
Antigen Diagnostic Tests
Antigen tests detect one or more specific proteins (i.e. antigens) from viral particles. Most currently authorized antigen tests can be used in point-of-care (POC) formats to provide answers fast—with results in as little as 15 minutes. Although antigen tests are highly specific, they tend to be less sensitive than molecular tests. However, antigen tests have the capability to scale to test millions of individuals daily due to their relatively low cost of production, easy-to-use format, and rapid turnaround time compared to molecular tests. Antigen tests also offer advantages in terms of greater flexibility when it comes to the handling and transport of specimens. For these reasons, they are often used to diagnose active COVID-19 infections as well as in time sensitive cases or when molecular tests are not possible.
Serology & Antibody Tests
In contrast to molecular tests or antigen tests that detect the virus itself, serology tests utilize blood samples obtained via finger-prick or blood draw to detect antibodies produced by a patient’s immune response to SARS-CoV-2; some can also identify the antibody isotypes (IgG, IgM, etc.). Common platforms for serology tests and antibody identification include lateral flow assays (LFA) and enzyme-linked immunosorbent assay (ELISA).
According to the FDA, it is possible that over time the broad use of antibody tests during clinical follow-ups can provide the medical community with more information about an individual’s adaptive immune response to the virus. This means that these tests may be able to help indicate whether or not a recovered person is at lower risk of infection and how long that risk reduction lasts. Importantly, they can also be used to detect recent past infections, even once the virus is cleared. In addition to supporting client diagnostic test development, Avomeen also developed our own serology assay, which we use to assess immune responses to COVID-19.
Neutralizing Antibody (NAbs) & Virus Neutralization Assays
Figure 2. Mechanism of Neutralizing Antibodies (NAb) Against the SARS-CoV-2 Virus
Many believe the most prevalent need in the continuing fight against COVID-19 will soon be the ability to understand the level of protective, neutralizing antibodies (NAbs), as determined by longitudinal studies of vaccine response and COVID-19 recovery. The measurement of neutralizing antibodies in vaccinated and recovered individuals will help to determine the duration of immunity against the SARS-CoV-2 virus and its variants. Although nearly everyone infected with SARS-CoV-2 and those vaccinated against it generate antibodies, it’s important to note that not all antibodies are created equal. Neutralizing antibody assays determine whether patient antibody responses provide true protection against potential future infection. Understanding of the levels of NAbs in individuals can provide critical information, including:
- When someone can take up normal activities without spreading the virus to others
- When a person will be less likely to be re-infected with the virus
- Which individuals may be optimal donors for convalescent plasma protocols
Viral neutralization is considered to be the “gold standard” for determining the efficacy of antibodies, and these viral neutralization assays measure the levels of antibodies that block the infection of host cells in an individual. Since SARS-CoV-2 invades host cells by binding to angiotensin converting enzyme 2 (ACE2) using a receptor binding domain (RBD) on the spike protein, some successful NAb tests determine if antibodies can block this binding event. Additional NAb assay development approaches and strategies remain a pressing diagnostic need.