March 2, 2021

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Commission for the Evaluation of Diagnostic Tests Announced | government

For the first time, Puerto Rico has a Commission for the Evaluation of Diagnostic Tests (PRoDTEC, for its acronym in English), which gives the island the ability to expedite the review and approval of the use of in vitro diagnostic tests to detect the SARS-CoV-2 virus, responsible for the Covid-19 disease. This in collaboration with the Food and Drug Administration of the United States (FDA, for its acronym in English).

This was announced this Wednesday by Dr. José Rodríguez Orengo, executive director of the Puerto Rico Public Health Trust (PRPHT), a program of the Puerto Rico Science, Technology and Research Trust (FCTIPR); as well as the secretary of the Department of Health (DS), Lorenzo González Feliciano; and the professor of Yale University and trustee of the FCTIPR,Daniel Colón Ramos, at a press conference.

The PRoDTEC is made up of a total of eight members, including Dr. Marcos López Casillas, research manager at FCTIPR within the Health Institute program; the graduate, Agnes A. Rodríguez Soto, senior consultant in Quality Systems at Business Excellence Consulting; and Dr. Federico Goodsaid Sanjurjo, CEO of the company MBQ Pharma.

These three scientists will work in conjunction with five other members who will be serving on the commission as non-voting consultants. There is a representative of the Assistant Secretary for Regulation and Accreditation of Health Facilities (SARAFS) and four representatives of the four medical schools of Puerto Rico.

“In terms of what we are doing with the DS, it was mainly to collaborate to create a commission to obtain from the FDA the consent to grant authorizations of emergency uses for tests that detect the virus in particular, RNA, SARS-CoV- 2, but we are also going to be working with different laboratories and companies that have to make the antigens for this virus or the antibodies that are generated in people who are infected with the virus in order to see if there is this type of response ”, explained Rodríguez Orengo.

This will be together with the different laboratories in Puerto Rico and the companies, which offers a scientific autonomy that we did not have at the time, since on several occasions some protocols have been submitted to the FDA and they are taking “quite a long time”, for The aim is to accelerate this process, added Rodríguez Orengo.

“In addition to that, what we have seen is that for the month of July it was our peak in relation to molecular tests when we could have about 8,000 daily tests when we are dividing that week into five days and then by the beginning of August we had a decrease of about 3,500 and 3,800. At the moment, we are between 4,000, 4,500 even in some days that can reach up to 5,500 and 6,000, “he said.

“With the creation of this commission, which is PRoDTEC, it is expected that this authorization process will be speeded up here on the island so that many laboratories can participate and thus maximize the potential of creating daily tests for all Puerto Ricans to have an overview completeness of the epidemic and provide greater support for the contact tracing that is so important at this time, ”stated Rodríguez Orengo.

For his part, González Feliciano said that this effort demonstrates the collaboration that exists between different entities and people who want to do good for Puerto Rico. He added that “the most important part of this is that we have joined forces to combat the Covid-19 situation. This is an additional collaborative effort – one of the many that we have carried out since I started here in April – recognizing that the Trust is essential in what has been developed today in Puerto Rico in public policy in relation to Covid-19 ”.

“It is important to recognize that when we started in April we had 1,800 tests and with that public policy was made in Puerto Rico. To date, over a million tests have been generated and the importance of integrating the DS with the Trust and other entities that are interested in analyzing that data is that a large amount of scientific effort has been generated and that we have been able to sit down at the same table to lead the country and make public policy with scientific data, “said González Feliciano.

He stressed that the fact that the Trust can choose to analyze tests and approve them locally gives Puerto Rico a “gigantic scientific autonomy”, which is necessary to be able to combat and even compete with the resources that are available to combat this condition of Covid-19 .

“In the same way, it recognizes the power of Puerto Rican scientists. The amount of science that exists in Puerto Rico that we sometimes underestimate and we second to the opinion generated by the world’s scientists with the presumption that Puerto Rico cannot do it. I believe that this effort, like many of the efforts that have been generated, including in the discussion, even if it is not favorable for the Department, is necessary, ”he said.

González Feliciano emphasized that Puerto Rico today joined seven states that also have this authority from the FDA to be able to evaluate the tests and adjudicate to what extent they can be used on the island in the “absence of having to wait three, four, five or six months by the FDA. This does not imply that we do not submit to the FDA’s effort, because there always has to be a continuous validation with the FDA, but it gives us the power to provide the information to the FDA so that we can act on the plan ”.

Earrings a for the extension of this note.

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