PARIS – Being first to market does not mean you have won the game. With competition heating up in a new category of in vitro diagnostics (IVDs) called syndromic testing, that lesson is being refreshed as a new case study takes shape.
Based on multiplex polymerase chain reaction (PCR) assays, syndromic testing for infectious diseases in just a few years has captured 45 percent of the $2 billion market segment for molecular diagnostics, according to Grand View Research based in San Francisco.
With a projected annual growth rate of 13.3 percent PCR-based molecular diagnostics are expected to dominate the IVD market through 2024.
The trailblazer in the field is Salt Lake City Utah-based Biofire that after breaking open a new approach for the rapid detection of multiple pathogens, was acquired in January 2014 for more than $450 million by bioMérieux, based in Marcy l'Etoile, France.
A few months later Basel, Switzerland-based Roche Diagnostics paid the same price for Marlborough, Mass.-based Iquum Inc. and in 2016 Danaher Corp.-based in Washington, D.C. paid over $4 billion for Sunnyvale , Calif.-based Cepheid Inc.
This week, a nascent entrant to the field is unveiling a new technology platform at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna.
The platform has yet to start its pivotal trial for a CE mark, and there is only one assay panel, acute respiratory syndromic testing targeting 22 viral and bacterial pathogens simultaneously.
The roughly $50 million in capital raised by upstart Statdx SL, based in Barcelona, Spain, sounds puny compared to the sacks of money being thrown around by the major players for novel technologies.
But the company is not making a technology play with the Diagcore platform, which it assembled using tried-and-true pathogen detection systems, thereby avoiding a long an expensive development process.
Instead Diagcore was designed by a pair of engineers to target ease-of-use and lower costs across a full menu of assays.
A fully-integrated, platform with a footprint small enough to squeeze into the crowded point-of-care (POC) competition, Diagcore combines multiplex real-time PCR with a second detection system for immuno-assays.
Requiring no sample preparation, a nurse in intensive care or an emergency department inserts the sample into a cartridge, slips the cartridge in the analyzer unit and within an hour receives a yes-or-no result across a series of probable pathogens.
The rapid qualitative result in syndromic testing has quickly swept aside the traditional practice of sequentially testing over several days each suspected pathogen with a quantitative result.
Instead of trial-and-error, a clinician can rely on the syndromic result to pinpoint what the central lab should look for and to more quickly make a decision about patient treatment.
"When we started the company, many people said we would be too late, that there were many companies already out there," said Statdx CEO and co-founder Jordi Carrera. "We have proven that wrong if you look at the attention we are capturing with the clinical community, and if you look at the investment we have attracted with their willingness to continue. These are very exciting days in diagnostics and we are happy to be part of it."
"We developed something simple without fancy technology that is published in prestigious journals. We are industry people who wanted to make a business," he said.
Formerly an aeronautics engineer, Carrera and co-founder Rafael Bru were executives with the Barcelona, Spain-based Werfen Life Group that in the early days of syndromic testing distributed both Biofire and Cepheid products for Spain, Portugal and Italy.
"We knew which products were working and why they were successful. We built our company based on these specifications, better and cheaper ways to do the same things.
Carrera said the current platforms acquired by the major companies were developed based on technologies 15 years ago. Because Diagcore development began in 2010, he said there was access to advanced real-time PCR technology that enabled them to design an open system.
"For companies with odd technologies, each new assay requires years and years of development. Because we use real-time PCR and because everyone in the world knows PCR, it makes it far easier to develop new assays. There is an efficiency in lower research and development costs, and a much faster time to market," he said.
For customers the focus on lowering costs pays off in more efficient use of reagents, which are pre-loaded in the assay cartridge.
"A major differentiator in Diagcore includes features that our competitor does not have, which become critically important for winning end-user adoption. For example, eliminating sample preparation may sound trivial but in an emergency department these added steps require more training and can lead to errors," he said.
Following on the unveiling of the Diagcore platform in Vienna, Carrera said the pivotal trial will start at four sites in Europe with a goal of winning a CE mark for commercialization by the end of 2017.
"The next step for success is to have a strong commercial arm to bring it to the markeat at the right speed. This is where we are working now to have everything in place by the beginning of 2018 to launch the product," he said.
"It is a big market with big players who have an enormous commercial reach. If we as a start up company had to build our own sales force it would take years and years," he said, adding that not all the leading IVD companies currently have a POC device for syndromic testing.