Unicamp's Medicinal Chemistry Center (CQMED), the Mendelics genomics laboratory and the Brazilian Industrial Research and Innovation Company (Embrapii), have just signed an agreement to improve the saliva test for Covid-19. CQMED is responsible for developing two key test reagents that are imported, and Mendelics will carry out the tests.
The idea is to combine the expertise of the Center for Medicinal Chemistry in the design and production of specific enzymes at scale and the logistics of Mendelics. With this, the expectation is to increase the availability of these essential components for the country's autonomy in the production of tests for Covid-19. Currently, one of the main bottlenecks in the fight against coronavirus is the mass testing of the population. This is because broad, fast and accessible testing is essential to track the virus, quickly identify new cases and prevent the transmission of the disease.
"The test called RT-LAMP #STOPCOVID brings security when returning to face-to-face work activities, schools and leisure activities. The Brazilian production of inputs by CQMED will increase the availability of the test in Brazil, reduce costs and guarantee supply independent of the global demand for tests.", says David Schlesinger, CEO of Mendelics.
The new molecular test for Covid-19 was developed by Mendelics in partnership with Hospital Sírio-Libanês. It is capable of identifying the presence of SARS-CoV2 in a saliva sample during the period of active virus infection. Like RT-PCR, it does not detect the antibodies of people who have already recovered from Covid-19, but rather the virus itself. The protocol is based on a technique called “reverse transcriptase with loop-mediated isothermal amplification” or RT-LAMP. This technique is already used to diagnose other diseases such as Dengue, Chikungunya, Hepatitis A and Zica.
O RT-LAMP #STOPCOVID was launched last June by Mendelics and has sensitivity and specificity comparable to RT-PCR, in addition to enabling non-invasive self-collection without the need for swabs. The saliva test manages to maintain sample stability for up to three days at room temperature and suppresses the extraction stage of the virus's genetic material (RNA).
The technology developed for this test is capable of producing results in a few hours, much faster than available RT-PCR tests, and the cost of RT-LAMP is five times lower than RT-PCR, whose supply of inputs is heavily limited worldwide.
The partnership
CQMED has expertise in characterizing little-known proteins related to human diseases, especially cancer, infectious and neurological diseases. With the growing demand for Covid-19 tests, the Center expanded its operations in the production of inputs (proteins) to serve Unicamp's Covid-19 task force. O know-how of input production brought CQMED closer to organizations interested in combining research and genetic diagnosis.
Katlin Massirer, CBMEG researcher and project coordinator at Unicamp, highlights that Embrapii catalyzed the partnership through the emergency plan for Covid-19 projects, as well as online workshops that brought together the interests of universities, SENAI and companies. “Thus, the Embrapii model of resource participation between the three pillars university, Embrapii and company, made it possible to put together the action plan and allocate resources for a project”, she explains.
In the project to improve reagents, researchers from Unicamp and Mendelics join forces to maintain high availability of Covid tests. CQMED will work on the development of two test enzymes and the execution of quality control while Mendelics will focus on adapting the reagents for application in the RT-LAMP tests already in operation.
CQMED located at Unicamp was founded in 2015 as a PITE-FAPESP project and was accredited as an Embrapii Unit in July 2017. It has competence in the area of pharmaceuticals and medicinal chemistry, more specifically in the initial phase of developing new drugs. CQMED has a platform for the development of inhibitory molecules against specific targets related to human diseases. It also represents the INCT of Medicinal Chemistry, supported by Capes, CNPq, Fapesp and Unicamp.
Mendelics is the first and largest Brazilian laboratory specialized in Next Generation Sequencing (NGS). It was created in 2012 by doctors David Schlesinger, Fernando Kok, André Valim and bioinformatician João Paulo Kitajima, and invested by Laércio Cosentino (chairman of the board of Mendelics), the Finhealth fund and several investors. Mendelics' mission is to make genetic diagnosis fast, accurate and accessible to everyone who needs it. With the largest sequencing laboratory structure in Latin America, more than 80.000 genomic samples already carried out, a team of over 140 collaborators, with pioneering technical and analytical processes and international quality standards, it has established itself as a reference in genetic analysis. Mendelics is the only Latin American genomic laboratory to obtain accreditation from CAP (American College of Pathologists - #8671464) and INMETRO (NBR/ISO-15189) and is also internationally recognized and awarded by MIT for the development of Abracadabra®, an exclusive platform which uses artificial intelligence to make genetic analyzes more accurate and efficient. Since its foundation, it has continued to develop innovative products in the health sector, such as the Cheek Test, a complementary exam to the heel prick test for newborns, capable of identifying more than 310 early childhood diseases, which tend to be serious and silent, but which already have effective treatments when identified early.
The Brazilian Industrial Research and Innovation Company was created in 2013 as a social organization that has autonomy in managing funds from the Ministry of Science, Technology and Innovation and the Ministry of Education with the aim of stimulating innovation in Brazilian industry, promoting interaction between institutions of technological research and companies in the industrial sector. Its operating model provides for financing up to 1/3 of the total cost of each approved project, with non-refundable resources (i.e., the industry does not need to return the amount contributed) and the remainder is divided between the industries and the EMBRAPII units. .
