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Spain's Certest Expanding to Support Growing MDx Business

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NEW YORK (GenomeWeb) – Certest, a diagnostics developer and manufacturer based in Zaragoza, Spain, has been expanding operations to meet the growing demand for its molecular biology products.

Founded in 2002 as an immunodiagnostics firm, Certest specializes in CE-marked in vitro assays for clinical diagnosis that now include real-time PCR-based kits for detecting infectious diseases sold under the brand name ViaSure.

For immunodiagnostics, the firm has used mainly immunochromatography to develop rapid tests, Nelson Fernandes, general manager of Certest, said in an interview. Initial tests were designed to detect antigens in stool samples, but the menu now includes RDTs for inflammatory and tumor markers, respiratory antigens such as influenza, adenovirus, and respiratory syncytial virus, urine tests for S. pneumonia and Legionella, and combination assays multiplexed with up to four targets.

The company's RDTs were initially differentiated from competitors' tests – which tended to be cassette-based and contain a test strip inside – by consisting solely of a test strip.

"This allowed us to have a test that was simpler to use, and also cheaper in terms of the cost the raw materials, giving the company the opportunity to enter any type of market," Fernandes said. Now, the company sells more tests in a cassette format, he said, but the original simplification was a first step to set the company apart and give it an edge at its founding.

Certest also develops turbidimitry assays to quantify tumor and inflammatory biomarkers in fecal samples. The company currently markets a test for calprotectin, a protein present in during the inflammation of the intestine, and another to detect hemoglobin, which can indicate bleeding associated with gastrointestinal pathology.

And, like other diagnostics makers such as Meridian Bioscience, Certest sells the monoclonal antibodies and recombinant proteins that it also uses to make its rapid tests.

However, "The future of the company is PCR and molecular biology," Fernandes said.

As with its early immunodiagnostics, the firm has tried to differentiate its ViaSure kits from some other PCR-based tests on the market, he said.

ViaSure kits are completely lyophilized, so that the tests can be shipped and stored at room temperature, eliminating the need for cold chain transportation. The tests also have shelf lives of up to 24 months, Fernandes said, which is "much higher than most of the other manufacturers in the world," he added. The tests are also validated on several different platforms and can be multiplexed, as is the case with its assay for three different strains of pertussis.

Certest is housed in a building that is only five years old, but the firm is currently constructing a new building to add 4,000 square meters of space, just for molecular biology. "We are making a huge investment for the future in the growth of the company, and we are also hiring new people," Fernandes said. The firm also had around $12 million in revenues last year, an approximate 40 percent increase year over year, he said, and it expects something more along the lines of $15 million this year. And, although sales in molecular testing represented a small proportion of rapid test sales last year, Certest projects that both business segments will grow over the next five years and molecular sales will come to represent about 15 percent of its business by 2021.

Certest began developing its molecular menu in the past few years. The company's PCR-based tests are more sensitive and specific than RDTs, and customers often use them to confirm rapid diagnostics. Thus, the company added PCR testing to its menu to "follow the market and follow the needs of our customers," Fernandes said.

The company had previously worked with several local hospitals in Spain to obtain patient samples for in-house testing. Because of its history with gastrointestinal pathogen RDTs, it initially used existing GI infection samples to develop assays for viruses, bacteria, and parasites in the ViaSure line.

It has since extended its qPCR kit portfolio to include respiratory infections, tropical infections — like Zika, dengue, chikungunya, malaria, and yellow fever — and also some tick-borne diseases.

"Mainly, we are developing tests according to our customer's expectations, depending on the country or area," Fernandes said, adding that the company can develop new tests in less than three months, supported by its research and development in monoclonal antibodies and recombinant proteins.

Certest markets its products in more than 120 countries, primarily through distributors. The company has several OEM agreements and manufactures for other brands, while in the US it sells raw materials.

"At this stage, we don't have [US Food and Drug Administration] approval," Fernandes said, "But that is something we are thinking about doing as a next step for the company." He added that the US raw materials market continues to be "a very good market for us."

Competitors for Certest's assays differ by assay type and global region. In immunodiagnostics, Fernandes said the most significant ones are Germany's R-Biopharm, Belgium's Coris BioConcept, and CTK Biotech in the US. For PCR, Seegene, Bioneer, Altona, and Fast Track Diagnostics are the most common manufacturers the firm sees in the market with competing products.

Certest develops and manufactures as much as possible in house, Fernandes said. The firm does not, however, have expertise in equipment, particularly for nucleic acid extraction and amplification. The company is considering potentially partnering in the long-term for instrument manufacturing, but for now it is more focused on test development, he said.

Certest's products have also been evaluated and validated by end users, who often publish or present data in posters at conferences. For example, the company's RDT to detect rotavirus and adenovirus was recently evaluated by a group in Italy and showed substantial agreement with a test from BioMérieux. And, at the European Congress of Clinical Microbiology and Infectious Diseases last month, three posters described validation of the firm's qPCR tests, including ones for Clostridium difficile and enteric pathogenic protozoa.

Overall, "Our prospects are quite interesting for the future, and we are quite happy with the results we are getting," Fernandes said.