On June 8, 2020, Phosphorus Diagnostics, a renowned genomics firm located in New York with a lab in New Jersey, announced its partnership with the US Food and Drug Administration (FDA). The FDA approved an Emergency Use Authorization request for COVID-19 tests using saliva samples. The self-test kits are available online on the Citizen app, making this the second unsupervised home test approved by the FDA.
The Citizen app allows anyone to track their symptoms, find testing locations, and learn if they may have been exposed to the virus. The app is available for both iOS and Android users.
How to Acquire the Self-Test Kit
You can select and order your test kit through the online checkout process. You will fill out a medical questionnaire, which will then be reviewed by an assigned physician. Upon approval, the test kit will be delivered and collected from the consumer’s home. Test results will be available within 72 hours after the test kit is returned with your saliva sample; results can then be discussed with medical personnel.
How the Citizen App Works
When Bluetooth is activated, the app’s SafePass feature can track the location of possible COVID-19 exposure. It can monitor individuals’ contacts with someone who later tests positive. For 3 months, individuals around high-risk areas of exposure will be offered tests by Phosphorus Diagnostics.
Phosphorus recognizes an individual’s privacy, so this is an opt-in service. This service does not share names or personal information publicly. Any data you enter deleted entirely every 30 days.
Home saliva sample collection is simpler and less invasive compared to swab-based procedures. The home testing kit will have strict standards and guidelines to ensure safe and accurate results. OraSure’s Oragene® Dx (OGD-510) saliva sample collection has proven to be a reliable test performance method when compared to gold standard methods.
Alex Bisignano, Phosphorus co-founder and CEO, stated that he was proud of this new project and the partnership with Citizen. The home test kit will give everyone a chance to be tested safely from their homes with the support of medical personnel. These innovative solutions were developed to contain the pandemic.
Phosphorus is in full compliance with FDA Guidelines for coronavirus diagnostic tests, having submitted its validation data under the FDA’s Emergency Use Authorization (EUA) during this public health emergency. The tests were developed at Phosphorus’s CLIA-licensed laboratory in Secaucus, New Jersey. Phosphorus genomics also provides other advanced genomic tests using Next Generation Sequencing (NGS) technologies. Their laboratory is CLIA and CAP-certified and licensed in all 50 states. Phosphorus has recently shifted their operations to COVID-19 testing to help solve this public health crisis.
How Phosphorus Genomics’ Saliva-Based DNA Test Works
You can order a self-test kit from the Phosphorus website. Once the order is complete, a test kit will be sent to your address, containing an easy-to-use saliva collection unit. You will receive an email with a link and instructions to help with your test’s online registration.
Within three days of the sample’s arrival at the Phosphorus lab, technicians will complete the DNA extraction process. Your DNA will be examined based on millions of data points, which will determine your gene sequence variations. The tests are sequenced several times to ensure the accuracy of the results.
Once your data is processed, our team will review variations found to be high-risk; then, your report will be made available. In the case of high-risk genetic variations, you will be offered an appointment with a board-certified genetic counselor for guidance and to determine a course of action.
Our mission is to improve human health by tackling the challenge of the human genome. We offer high-quality and pocket-friendly genetic test portfolios. Phosphorus Genomics tests assess your health holistically with the PhosphorusONE Health Screen, specializing in fertility, lipidology, ophthalmology, oncology, neurology, pharmacogenetics, pediatrics, and metabolic disorders.