New York City-based genomics firm Phosphorus Diagnostics LLC has received emergency use authorization (EUA) from the FDA for its COVID-19 saliva test. Following the EUA, the company has announced a partnership with healthcare engagement and clinical adherence technology platform company BioIQ in making the test more widely available to people across the US. The test can be taken at home, allowing individuals to send their saliva samples to Phosphorus’ laboratory in Secaucus, New Jersey for testing.
The FDA authorization was granted after Phosphorus conducted a rigorous round of validation studies for its test.
The test kit will be available for purchase for $140 after completion of an online questionnaire to determine eligibility. A health care professional will evaluate the medical information provided in the online assessment tool, after which recommendation for a test may be given. If approved, a sample collection kit will be directly shipped to a consumer’s home. Upon receipt of a sample at the lab, test results are expected to be made available within 72 hours, according to Phosphorus.
Through the collaboration with Phosphorous, BioIQ will assist in linking employees as well as health care plan members to the testing. BioIQ has designed a health technology platform that supports the assessment of symptoms and exposure digitally, contact tracing and follow-up care navigation.
Phosphorus’ test is now the second saliva-based test approved by the FDA. Earlier in May, a saliva test developed by Rutgers University researchers received FDA approval, also allowing people to self-administer the test at home.
In a press release from the company, Alexander Bisignano, co-founder and CEO of Phosphorus said, “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.” He went on to say, “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.”
In a statement announcing the partnership with BioIQ yesterday, Bisignano said, “Phosphorus is excited about this partnership with BioIQ. We understand that testing is essential when it comes to re-opening the economy, and this alliance will ensure that people from coast to coast have access to safe, efficient and effective COVID testing.”
BioIQ Ceo Justine Bellante commented in the statement, “Additional RT-PCR COVID-19 testing capacity and convenience through home sample collection is a critical need for employers, health plans, and government agencies.” He added that, “The partnership with Phosphorus adds the sophistication and validation of a leading genomics laboratory to our network and the expanded use of home sample collection and testing for COVID-19.”
Compared to traditional COVID-19 testing methods, which have primarily involved sample collection using nasal swabs, saliva tests are much less invasive and can be self-administered in a home setting.
Saliva tests require a person to simply spit into a collection tube, seal and package it and send it off to the designated laboratory for testing. Turnaround times are designed to be more rapid with test results available in under one week.
Minimizing Exposure and Ease-of-Use
The test minimizes exposure for patients and healthcare providers as the test can be taken at home. In addition to BioIQ, Phosphorus has plans to partner with other healthcare facilities as well as employers who wish to conduct COVID-19 testing; through the collection of samples at home, exposure risks would be significantly reduced.
The ease and convenience associated with at-home saliva-based testing will allow for more widespread and repetitive testing, both of which are a key part of protocols by experts to containing the COVID-19 pandemic.
Through validation studies, Phosphorus’ OraSure’s Oragene Dx (OGD-510) saliva collection device was demonstrated to be “a reliable method for test performance comparable to gold standard methods,” according to the press release. It also stated that Phosphorus 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 authority. The tests were developed at Phosphorus’ CLIA laboratory in Secaucus, New Jersey.
Phosphorus’ testing protocols used strict standards in ensuring a high degree of accuracy and reliability in the test results. Moreover, Phosphorus is one of the first Emergency Use Authorized test assays that completed a rigorous clinical agreement study, going beyond the synthetic sample performance study initially required by the FDA.
The saliva test is also one of the first that will be made available to consumers directly through its COVID-19 online assessment tool. These efforts will help increase testing while allowing people to self-administer tests from within the comfort and safety of their homes.