While waiting for the approval of a vaccine to combat Covid-19, it is of utmost importance to correctly diagnose it to stop its spread, especially for asymptomatic cases.
Given the lack of sufficient reagents in Puerto Rico to perform these molecular tests, alternatives are sought. For this, LifeGene-Biomarks will be developing molecular urine and saliva tests for the detection of Covid-19, in its laboratory on the Island.
The studies begin this week, with 600 samples collected from saliva, nasal mucosa and urine. Among all the participants, from whom three samples were taken, there are about 15 positives for the novel virus.
“The percentage of positivity in Puerto Rico is over 10%. (The test) requires approval from the FDA (Food and Drug Administration), which is running faster (than usual in the novel virus), "said Rafael Guerrero Preston, founder and president of LifeGene-Biomarks.
Against this background, the Puerto Rican scientist understands that this year his test could be used on the island. He is immersed in the project to "increase the number of molecular tests in Puerto Rico. I have reagents for 4,000 tests. If the experiment of grouping the samples into five comes out, it would theoretically have 20,000. ”
At present, there are other researchers in Puerto Rican soil doing initial experiments in molecular tests on saliva. Therefore, Guerrero Preston may be the only one locally testing with urine.
Focused on preventing cancer
On the other hand, it should be noted that LifeGene-Biomarks is the first Puerto Rican company dedicated to discovery and development of molecular tests for cancer prevention.
The company received the Small Business Innovation Research (SBIR) Fast-Track Grant from the National Institute of Health (NIH) to market the Cervical / MethDX molecular test for prevention cervical cancer, caused by the human papilloma virus (HPV). It identifies cervical dysplasia (abnormality), through DNA markers, in women who test positive for HPV and who are at risk of developing cervical cancer.
"I have to show the FDA that the test works . If it is valid, it gives me the certification so that it can be marketed and the medical plans can pay for it. Certification can take 90 days, on average, "he estimated.
His original schedule was to have enough data to submit initial results to the FDA in the summer of 2021.
" That may be delayed a little for the Covid-19 theme; if not it will be by the end of next year. If it works out, by spring or summer 2022 we hope that they will give us the certification because the preliminary results are good, "he assured.
The Cervical / MethDX is practiced in the same liquid as those of the pap smear and HPV. This scientist analyzes the DNA of the woman, and not the DNA of the virus as it is done in the HPV test.
“If the results are negative in our test, (the woman) does not need to have colposcopy or cervical biopsy because the the probability that they will be normal is high, "he said.
Colposcopy is an examination of the vaginal cavity to determine where to do the biopsy. Whereas cervical biopsy is to determine premalignant cells or premalignant changes in the tissue of the cervix.
“The idea is that nobody suffers from this type of cancer because every two minutes a woman dies of cervical cancer in the raises. That is unacceptable because we know how to prevent, detect and work this cancer. There are vaccines for HPV, "said a member of the Johns Hopkins School of Medicine faculty.
Cervical / MethDX could currently be used anywhere in the world that does not require FDA approval, as required in the United States and Puerto Rico. Guerrero Preston is the first graduate of the Doctoral Program in Public Health, of the School of Public Health of the Medical Sciences Campus, of the University of Puerto Rico.
“As a scientist and Puerto Rican, I am proud to do this from Puerto Rico; that we are the ones who are at the forefront of innovation in the field of pathology. It is a satisfaction to help improve health and women's health throughout the planet because it is a new tool, "he said with pleasure in an interview with EL VOCERO .
In addition, he has patents granted to detect cancer tumors head, neck and gastric. He also has patents developed for the detection of liver, gallbladder, lung, bladder and breast cancer.
“The changes I look at are epigenetic, which are the first molecular changes that are seen when a cell transforms from normal to precancerous . From that moment of transformation, to the doctor or person realizing that something hurts or bothers them, it can take five to 15 years, "explained the researcher.
There are theories that these changes may be reversible when they are discovered early and the person makes changes in their lifestyle. Such as improving your nutrition, exercising, resting, meditating, practicing yoga, etc. However, there are no clinical studies confirming this.