Janssen Advances Alveo’s At-Home COVID-19 Testing Platform

May 05, 2020 - Alveo Technologies recently announced a collaboration with Janssen Pharmaceuticals, part of Johnson & Johnson, to advance the company’s at-home testing platform that detects viral infections, including COVID-19. 

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The be. well testing system includes analyzers, nasal swabs, and cartridges for the detection of viral infection diseases, including Respiratory Syncytial Virus (RSV) and SARS-CoV-2. The platform can be adapted to detect a wide range of diseases that threaten public health, Alveo noted in the announcement. 

“Affordable access to real-time, at-home results will transform the way individuals, healthcare providers and public health professionals identify and manage disease outbreaks,” the company stated. “With be.well™, we will know sooner, act faster and make better-informed decisions toward personalized intervention options that benefit individuals and the entire population.”

Alveo will use a phased approach to gain Emergency Use Authorization (EUA) for SARS-CoV-2 assays, followed by a test for home use. 

“With be.well™, we are talking about an entirely new approach to detect and help manage infectious diseases in individuals and populations. With a low-cost, easy-to-use device/app combination, we expect to have real-time diagnostic data to track and respond to disease outbreaks at a speed and scale that we could not have come close to previously,” said Ron Chiarello, PhD, founder, CEO and chairman of the Board of Alveo. 

Alveo will receive financial support and technical regulatory counsel from Janssen associated with regulatory submission of the platform, which will diagnose various viral infections. 

“Janssen’s technical and regulatory support will help advance our platform, which we hope will empower people for the first time at home with on-demand infectious disease detection that may enable receiving treatment at the earliest possible time – saving countless lives and medical resources – and enabling global infectious disease surveillance on a scale, and at a speed, never seen before,” the company stated in the announcement.

Although experts previously believed antibody tests were vital to reveal immunity and advance drug and vaccine discovery, lawmakers recently uncovered significant gaps in the Trump Administration’s handling of this testing. 

One of the main challenges lawmakers found was the White House’s plans to reopen the economy. The lawmakers argued that the plans are flawed by their dependence on COVID-19 antibody tests, which face vital unanswered scientific questions. 

Additionally, FDA did not review any COVID-19 “rapid” antibody test kits before they went to market and cannot validate the accuracy of ones currently on market.

Other Subcommittee findings included: 

• Lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy
• Companies are ignoring requests from HHS to voluntarily submit their tests for validation
• FDA and CDC have not put forth standards and guidelines for serological antibody tests, departing from practices governing molecular tests
• FDA has failed to police the COVID-19 serological antibody test market, has taken no public enforcement action against any company and has not conveyed any clear policy on serological tests, but rather has issued a series of unclear clarifications

These findings were based on a briefing with senior officials from FDA, CDC, and HHS. 

“Serology testing for coronavirus has the potential to be a critical tool going forward for our nation.  Unfortunately, senior FDA and CDC officials admitted that they have not put Americans in the best position to use this tool,” Raja Krishnamoorthi, chairman of the Subcommittee, said in the announcement. 

“When it comes to serological testing, more should be done to help protect the American people from suspect companies seeking to take advantage of the crisis.  They have put the public’s health at risk by allowing inaccurate and potentially fraudulent tests to spread unchecked.”