Wednesday, October 28, 2020

Phosphorus Diagnostics: A Milestone for At-Home COVID-19 Testing

After thorough and intensive validation studies, Phosphorus, a New York City-based genomics firm, has been given the green light by the US Food and Drug Administration (FDA) to proceed with saliva testing for COVID-19. This is the second at-home, unsupervised analysis of its kind approved by the FDA so far, featuring at-home sample collection. In light of this development from Phosphorus, the test has been made available online on their website, through health care facilities and employer partnerships who are on the forefront of resuming work with safe working conditions.

Testing Procedures

The saliva-based test has proven to be a better alternative to swab-based methods, which involve repetitive and tedious testing protocols.

Phosphorus has outlined effective protocols to be followed to acquire the test.
Choosing and ordering the test can be done on their website in a process that is friendly, confidential, and time-efficient.

Consumers will fill out a medical questionnaire to help the firm gather vital information regarding the dynamics of fighting the COVID-19 pandemic.
After ordering the test and filling out the medical questionnaire, an independent medical examiner will review this information and approve the need for a test kit.

Upon approval, a sample collection kit will be sent to the consumer’s home for saliva sample collection. Instructions for collecting the samples are included to avoid any possible cross-contamination. The sample is then shipped back to the laboratory for testing, with results available within 72 hours after the lab has received the samples.

Complying With Guidelines and Standards

From the protocols used to the procedures used for testing the samples in their laboratory, it is evident that Phosphorus has complied with all standards required for this pandemic. Initially, the FDA required a synthetic sample performance study with validations done by them. However, Phosphorus has done more than that since it has become one of the first to be issued an Emergency Use Authorization generated by conducting rigorous clinical agreement studies with the FDA.

According to the reports submitted to the Emergency Use Authorization authority (EUA), Phosphorus Diagnostics has fully adhered to the guidelines stipulated within the FDA regarding COVID-19. The tests and their accompanying procedures were developed at Phosphorus's CLIA laboratory in Secaucus, New Jersey. The firm then partnered with OraSure to provide them with the saliva collection devices.

Partnership With BioIQ

In addition, Phosphorus has collaborated with BioIQ, a health care and clinical assessment technology platform, to help Phosphorus Diagnostics with the logistics of the saliva test. This collaboration has led to the easy-to-use saliva collection kit and protocols observed in the transportation of the samples to the lab. It has also enabled BioIQ's digital platform for symptom assessment, contact tracing, and follow-up care. The fruits of this partnership have proven to be reliable and effective compared to orthodox methods of testing.

Safety First

By making it possible for consumers to collect samples at home, this method of testing enables the pinpointing of COVID-19 cases while limiting possible cross-infections through close contact between health care professionals and patients. As indicated by the administration at Phosphorus Genomics, this testing procedure will allow people to be tested in the comfort of their homes, no matter their location.

Phosphorus Is Certified and Approved

Phosphorus Genomics helps health facilities incorporate the technology of next-generation sequencing (NGS) for more effective and accurate results. Its laboratory is approved and certified by the CLIA and CAP to carry out its operations in every state in the USA. Lately, Phosphorus has shifted its focus to the current pandemic. Today, most of its expertise is geared toward the handling of COVID-19.

In a recent interview, Alexander Bisignano, the co-founder and CEO at Phosphorus, acknowledged the efforts of the FDA so far in their rapid response to this pandemic. He added that it is their utmost duty to help the country get back on its feet.

This is a guest blog entry.

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