NEW YORK (GenomeWeb) – In response to the ever-changing landscape of clinical genetic testing, Gendia, a small Belgian firm that facilitates testing services between clinicians or clinical labs and diagnostic genetic laboratories worldwide, has seen its business shift from a large number of highly specialized genetic tests to a smaller number of increasingly common assays, in particular noninvasive prenatal testing (NIPT).
Gendia, which stands for Genetic Diagnostic Network, aims to "improve the accessibility, cost-effectiveness, and quality of genetic diagnostics on a global scale," according to its website. The Antwerp-based company is privately owned, profitable, and has 10 employees as well as a number of contractors. It was founded in 2003 by Patrick Willems, the firm's director, and Annie Vereecken, at the time the owner of AML, a large medical laboratory in Antwerp.
At the time, their goal was to build a global network of genetic testing laboratories with expertise in certain areas that can offer high-quality tests at a low price, and to offer their services to laboratories and clinicians in small countries who needed testing for rare genetic diseases but did not have sufficient patient numbers to offer those tests cost-effectively at home.
"The idea was not to set up a lab, because we thought that there were far too many labs already, but to set up a logistics network that would do what locally was not available," Willems told GenomeWeb. "So wherever you are, in Greece, in Turkey, if for some reason, a test is not possible in your own area or lab or country, we would do it."
In addition to serving as a sort of middleman between labs and clinicians on one side and testing labs on the other, Gendia also provides its customers with counseling services, both pre-test and post-test, for example with help choosing the right genetic test, suggestions for reflex tests if the first comes back negative, and additional information accompanying a positive test result. "We organize testing, accept samples, send out samples, accept results, send out results, and we do counseling before and after we get a sample," Willems explained.
Customers send their samples to Gendia, which processes them if needed — for example, extracting DNA — and sends them to the testing laboratory. Gendia typically negotiates a discounted price for the test and charges its clients no more than what they would have paid if they had approached the testing lab directly. "They rely on us to give them the best test for their money," Willems said, as well as to select the best testing lab.
Gendia still shares facilities and infrastructure with AML, which merged with another laboratory and was acquired by Sonic Healthcare in 2010, but is operationally and financially separate. Many of the testing labs Gendia works with are located in the United States or in Germany. In the US, they include, for example, Emory Genetics Laboratory, GeneDx, Baylor Genetics, Roche's Ariosa Diagnostics, Counsyl, and Color Genomics. "Usually, they have the best quality at the lowest price, with exceptions," Willems said.
However, the firm has no contracts tying it to these laboratories — for example, Gendia originally provided NIPT through Natera, then switched to Ariosa, and might switch again in the future. "We just choose and [then] reevaluate the cost-effectiveness and the quality" of the tests, Willems said.
According to its website, Gendia now offers more than 3,000 genetic tests, including molecular tests for more than 2,000 different genes. This year, the company expects to coordinate between 12,000 and 14,000 tests. The vast majority of these, about 10,000, will be NIPT, which Gendia only started offering in 2013.
Many NIPT samples come from Belgium and the Netherlands, and Gendia has a separate website for NIPT testing that is available in English, Dutch, French, and German. At the moment, Gendia sends out NIPT samples to Ariosa's US lab but will likely switch to a more local provider in the near future, Willems said. Most of its non-NIPT samples currently come from Europe and the Middle East.
When the company started out, most patient samples came from genetics laboratories in small countries that had a portfolio of in-house tests and outsourced more specialized assays through Gendia. But with the advent of NIPT, Gendia also started to directly serve local markets in Belgium, the Netherlands, and Finland.
Other tests that have been gaining in importance are molecular cancer tests and carrier screening for inherited diseases, which Gendia offers through Counsyl. In the future, Gendia also plans to offer liquid biopsy tests for cancer. "It's new of course, with limited clinical evidence, but everybody knows that it will be the most important genetic test in the upcoming years," Willems said.
The trend away from specialized single-gene tests and towards broad next-gen sequencing-based panels and exomes "makes our life a little bit more difficult," he said. In the past, Gendia used to get small numbers of samples from many different places for a variety of gene tests, which are now replaced by more comprehensive tests. "We think that our model, within a few years, will shift, and that we will be offering whole exomes, liquid biopsies, and NIPT — those will be, I guess, the only three remaining tests — to those countries that do not have them available," Willems said.
Will there still be a role for a company like Gendia at that time? "I think so," he said. "A lot of small countries do not have any genetic labs that have high standards and can offer these [tests] cheaply. So I guess there will still be a lot of outsourcing" and a need for someone to facilitate this.