Thursday, October 22, 2020

Puerto Rico panel gets FDA consent to authorize novel coronavirus tests

By on September 23, 2020

A lab technician processes specimens for Covid-19 testing. (Photo by Amanda Wagner, Navy; screen capture of https://www.defense.gov)

SAN JUAN – The Department of Health of Puerto Rico (DOHPR) and the Puerto Rico Science, Technology and Research Trust (PRSTRT) announced that they have collaborated in the creation of the Puerto Rico Diagnostic Test Evaluation Commission (PRoDTEC), a panel that will review and approve “with greater agility” the use of diagnostic tests on the island for the detection of the SARS-CoV-2 virus, which causes Covid-19 disease.

“Given the need to increase in Puerto Rico the capacity to diagnose COVID-19,” a joint news release reads, island health officials requested and received the Food and Drug Administration’s (FDA) consent to grant emergency use authorization for Covid-19 tests performed by local labs that meet the criteria.

“The Commission will be responsible for evaluating the validity as well as stimulating the development of new COVID-19 diagnostic methodologies and tests for the detection of the new coronavirus during the public health emergency in Puerto Rico. The creation of the PRoDTEC gives Puerto Rico the ability—in collaboration with the United States Food and Drug Administration (FDA)—to carry out evaluations to do tests with agility while maintaining scientific rigor. This is a cutting-edge initiative necessary to respond to the emergency with the best scientific knowledge. Puerto Rico has the scientific capacity to do so, and at the Department of Health, we want to leverage those talents and knowledge for the benefit of our people,” said Dr. Lorenzo González, Puerto Rico’s Health Department secretary. “The PRoDTEC aims to help Puerto Rico overcome the emergency we face by advancing the availability of COVID-19 diagnoses that help save lives and prevent infections. The structure of PRoDTEC is also an important step for Puerto Rico, beyond the pandemic, because it serves as a basis to speed up the implementation of new science-based diagnostic methods for other emerging infectious diseases in the future.”

After the novel coronavirus was declared a health emergency earlier in the year, an FDA memorandum in March allowed states and territories to request the power to evaluate and authorize the use of tests for Covid-19 in their clinical laboratories.

The FDA emergency use authorization process can typically take months.

“What this represents for the people is the ability to continue increasing the number of diagnostic tests in our battle against this virus with an agile process and a Commission with prominent scientists in Puerto Rico,” said Lucy Crespo, chief executive officer of the PRSTRT, adding that, in July, “Puerto Rico managed to achieve about 6,000 daily tests, then that number was reduced to about 4,000 daily tests. With the creation of the PRoDTEC, it is expected to streamline the authorization process so that more laboratories can participate and thus the potential of daily tests in Puerto Rico can be maximized.”

Under this state consent, it is not necessary to send validation evidence of the SARS-CoV-2 test to the FDA; instead, the state or territory assumes the responsibility of reviewing this evidence and authorizing the COVID-19 tests performed by local laboratories that meet the criteria. 

“This is an important collaboration between the Department of Health and the Puerto Rico Science Trust that will result in significant health benefits for the country, for this pandemic, and for future epidemics,” said Dr. Daniel Colón-Ramos, trustee of the PRSTRT and president of the scientific committee appointed to manage the creation of the PRoDTEC. “The Secretary of Health, Dr. Lorenzo González, delegated us without restrictions, but with the clear task of using rigorous criteria in the selection of candidates to form part of the Commission. The Scientific Committee of Trustees reviewed half a dozen competing nominations; and we unanimously selected as members of the PRoDTEC Dr. Marcos López Casillas, PRPHT research manager; Agnes Rodríguez Soto, Senior Quality Systems Consultant (Business Excellence Consulting) and Dr. Federico Goodsaid Zalduondo, CEO of MBQ Pharma. This is an important achievement for science and for Puerto Rico,” he stressed. 

As explained by the trust, the commission will submit a protocol for “expedited evaluation” of Covid-19 diagnostic tests for approval by the Health Department and then collaborates with the “Covid-19 Clinical Laboratory Working Group to establish said protocol in laboratories certified under CLIA (Clinical Laboratory Improvement) that meet the regulatory requirements to perform highly complex tests.”

To date, only Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York and Washington have been granted the consent, according to the release.