Singaporean molecular diagnostics firm Veredus Laboratories has achieved a CE-IVD mark for its PCR and microarray-based VereFlu test and accompanying VereID Biosystem technology platform, according to a company official.
The firm will also debut next quarter VereFoodborne, a new assay for use in food testing that also runs on the VereID platform, which is manufactured by ST Microelectronics. VereFoodborne is one in a pipeline of new tests the company plans to introduce this year.
Veredus first launched VereFlu for research and surveillance purposes in 2008. The test allows researchers to detect, differentiate, and identify Influenza A H1, H3, H5, H7, H9 with subtype ID’s of H1N1, H3N2, H5N1 and H9N2 and Influenza B, according to the firm. Now, the company has achieved a CE-IVD mark, which enables it to market the test for clinical use, according to Daniel Floerke, Veredus Labs' director of sales and marketing.
Floerke confirmed this week that VereFlu and VereID were recently CE-IVD marked, and noted that having CE-IVD designation is "very important" for the Asian firm in the European market.
He also said that Veredus is close to launching VereFoodborne, which will allow food companies to test for target bacteria such as Vibrio, Staphylococcus, Listeria, E. coli, Shigella, Salmonella, as well as Rotavirus.
Veredus founder and CEO Rosemary Tan told BioArray News during a visit to the firm's headquarters earlier this month that the company decided to target food safety because of a perceived need by food makers for higher throughput food-testing methods.
"Food safety is a huge concern and every year we have reports of food poisoning all over the world and not just in developing countries, but developed countries also have to deal with this issue now and then," Tan said.
"I met up with a food company a few years ago and I was told that every day they have to do a swab test to make sure that microbes are not growing in their facility," Tan said. "It takes them two days to find out if something is wrong, but two days is too late. Everything you made for two days and before than has to be destroyed, causing a lot of problems," she said. "With our system, you can get an answer within two hours."
Veredus is one of several firms that have developed food-testing panels in hopes of replacing older, traditional methods, like culture, as well as lower-throughput technologies such as PCR. For example, Taiwan's DR. Chip has developed arrays that are specifically used to monitor bacteria during the beer-brewing process (see BAN 6/24/2008).
From a broader perspective, most big array and biochip companies are making inroads in the food industry. Fluidigm, for instance, has disclosed that Dutch seed breeder Enza Zaden is using its platform for quality-control purposes. Illumina's Bovine BeadChips, meantime, are being used by some in the cattle industry to aid in the breeding process.
According to Tan, food testing is just one application area where the firm can apply its technology. Veredus at the end of 2009 launched VereThreat for research purposes, which is capable of indentifying and differentiating the organisms responsible for anthrax, smallpox, plague, and tularemia. Research programs are also ongoing in respiratory viruses, tropical diseases, and oncology. In a 2006 statement, Tan discussed the development of chips to detect "dengue, malaria, West Nile, yellow fever, typhoid fever, Japanese encephalitis, and other diseases."
"I have always believed that we should be a technology company and not just a pandemic company," Tan said. "That's why we have a pipeline of tests." Floerke said that Veredus will pursue a CE-IVD marking for "most if not each" of its chips as they become available, and will sell them for research or surveillance purposes until they receive such a designation.
Founded in 2003, privately held Veredus partnered with Swiss electronics giant ST Microelectronics in 2005 to develop applications for ST's In-Check lab-on-chip platform, which enables users to perform PCR-based amplification and microarray-based detection on the same silicon chip. A standard 1 inch by 3 inch VereChip contains enough real estate to host up to 500 individual probes.
ST has a similar partnership with Helsinki, Finland-based molecular diagnostics firm Mobidiag. Though the company has not yet launched tests on ST's platform, it has commercialized tests for applications such as sepsis using a separate technology platform manufactured by an undisclosed company (see BAN 12/15/2009).
ST "had at that time the best technology available for an integrated PCR microarray," Tan said. "What you can essentially do is amplify your sample, run it on the microarray, and identify. No one so far has really integrated the two steps together, the amplification process and the microarray."
Veredus' VereChips run on the company's VereID Biosystem, which includes a temperature control system, optical reader, software, and chip bar code reader. Floerke said that Veredus' engineering team is currently engaged in improving the existing system in ways that will increase its throughput and easy of use. VereID can currently process five chips at a time, and Tan said that the company's customers are interested in running more samples at the same time.
Other than its VereID Biosystem, Veredus also sells PCR detection kits and enzyme-linked immunosorbant assays.
Encouraged by the VereFlu project, ST and Veredus in 2006 set up a joint lab where scientists from both firms develop new applications for the In-Check platform. The lab is managed by Veredus and located at its headquarters in Singapore's Science Park. Floerke this week said the lab is still "running strong."