Phosphorus issued the following announcement on June 8.
Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public Through Web Order
At-Home Saliva Test Gains Federal Approval After Rigorous Round of Validation Studies
Phosphorus, a leading genomics firm headquartered in New York City with a laboratory in Secaucus, New Jersey, announced today that the U.S. Food and Drug Administration (FDA) granted the Emergency Use Authorization request for its saliva test for COVID-19 that features at-home sample collection. The test is available by ordering online, as well as through health care and employer partnerships aimed at safely resuming operations. This approval by the federal government comes after a rigorous round of validation studies.
This is only the second at-home unsupervised saliva test approved so far by the FDA.
Using a saliva-based collection method is simple and less intrusive, in comparison to the prevalent swab-based methods. This ease-of-use is a key characteristic to enabling the widespread and repetitive testing protocols proposed by experts to contain the COVID-19 pandemic.
To order the tests, consumers must take the following steps:
- Step 1—Choose and order the test through the online checkout process.
- Step 2—Complete a medical questionnaire.
- Step 3—An independent physician will review the medical information.
- Step 4—Once approved, a sample collection kit will be shipped to the consumer's home.
- Step 5—Test results will be available within 72 hours after receipt at the laboratory and will be accompanied by a consultation from medical personnel.
"COVID testing is essential to getting life back to normal. This test will allow people from coast to coast to be tested from the safety of their homes with the oversight of medical personnel," said Alexander Bisignano, co-founder and CEO of Phosphorus. "We thank the FDA for their hard work throughout this crisis and the quick action they have taken. We look forward to helping the country re-open."
Phosphorus testing protocols use strict standards to ensure accurate and reliable test results. Phosphorus is one of the first Emergency Use Authorized assays to have conducted a rigorous clinical agreement study above and beyond the synthetic sample performance study initially required by the FDA.
The company is in full compliance with FDA Guidelines for Diagnostic Tests for Coronavirus Disease-2019 during a Public Health Emergency and submitted validation data under the FDA's Emergency Use Authorization (EUA) authority. The tests were developed at Phosphorus' CLIA laboratory in Secaucus, New Jersey. OraSure's Oragene®·Dx (OGD-510) saliva collection device proved to be a reliable method for test performance comparable to gold standard methods.
Phosphorus provides advanced genomic tests using next generation sequencing (NGS) technologies to healthcare providers and hospitals. The Phosphorus laboratory is CLIA and CAP certified and licensed for testing in all 50 states. It has re-oriented its operations to focus on COVID-19 testing in order to bring its sensitive testing methodologies and extensive experience in genomics to this public health crisis.
Learn more about the Phosphorus COVID-19 Testing here.
About Phosphorus
Phosphorus's mission is to improve human health by better understanding and harnessing the power of the human genome. Having built the most comprehensive, high-quality, and cost-effective portfolio of genetic tests, Phosphorus is able to increase access and quality of care in the burgeoning field of genomics. The company currently provides panel-based, constitutional genetic testing in the specialty areas of Fertility, Cardiology, Lipidology, Oncology, Pharmacogenetics, Ophthalmology, Neurology, and Pediatric/Metabolic disorders. Phosphorus also offers the PhosphorusONE proactive health screen - the most comprehensive genomic test for taking a proactive look at your health. Additionally, Phosphorus provides the Elements™ software platform to enable any laboratory to easily deploy any of the Phosphorus genetic tests on-premise as a local solution. For more information, please visit our website at phosphorus.com.
Original source can be found here.
