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Sygnis Bolsters Product Pipeline With Development of Liquid Biopsy Assay


This article has been updated to include more information on the company's new product launches and clarify a point about its TruePrime technology.

NEW YORK (GenomeWeb) – Sygnis, a German-Spanish company focused on the development of products for DNA amplification, sequencing, and protein-protein interactions for clinical applications, recently announced that it had developed its first product for the liquid biopsy market, the TruePrime Cell-Free DNA Amplification kit.

The liquid biopsy assay uses the firm's TruePrime technology to amplify and detect cell-free DNA associated with tumor growth in patients' blood. Like other liquid biopsy products, it is a noninvasive alternative to traditional biopsies, and the firm aims to launch the assay later this year.

While it has not yet been tested in clinical trials, the company has done some preliminary experiments with the assay in collaboration with the University Hospital of Hamburg-Eppendorf's Institute of Tumor Biology in Hamburg. "We were able to detect cell-free DNA in very low concentrations," Miguel Viribay, Sygnis' VP of sales and marketing, told GenomeWeb. The kit was able to detect DNA mutations that were also present in the solid tumors and a KRAS A595 point mutation that was not detected in the tumor, Viribay said. Though the firm provided few details on the assay, it has published a poster on the technology.

The new product is part of the company's TruePrime product line, which includes kits for amplification of the whole genome in single cells, whole-genome amplification, and both single- and double-strand DNA amplification.

All of the firm's TruePrime products use an innovative multi displacement amplification (MDA) process, Viribay said. The regular MDA uses the combination of random primers plus phi29 polymerase to amplify the DNA. However, Sygnis' MDA amplification is based on a combination ot two primers, TthPrimPol and Phi29 polymerase, he said. Both enzymes were developed by Sygnis' scientific advisors Margarita Salas and Luis Blanco Dávila, he added.

When asked about the company's approach to the liquid biopsy market, Viribay noted in a follow-up email that Sygnis is "not a diagnostic company and our product is not a diagnostic product." 

"The majority of the companies which are developing liquid biopsy kits, detect specific sequences that could be used as a marker for certain  tumors, more in the pure diagnostic arena," Viribay said. "Our approach is more focused on the amplification of the whole population of cell free DNAs in the blood stream for further analysis with NGS or other methods." 

Sygnis is working on the global launch of its TruePrime Cell-Free DNA Amplification kit for the fall. In the meantime, it is also working on developing another kit for researchers to study protein-protein interactions.

"We are working on a whole-transcriptome genome kit," Viribay said. The idea is to create a product that enables researchers to get real-time gene expression data in order to put together a whole transcriptome.

It will use a combination of the company's TruePrime amplification technology and its SunScript technology. The SunScript kits are based on a thermostable reverse transcriptase that allows researchers the option to work at high temperatures, according to Viribay. This technology can be used to perform reverse transcription, reverse transcription PCR, and quantitative reverse transcription PCR, he added.

Additionally, Viribay told GenomeWeb that the firm is about to launch a new version of its TruePrime Single Cell Whole Genome Amplification kit. The new version of the kit made improvements to lysis conditions. "Lysis is a key step in a high precision process like the whole genome amplification from a single cell, " Viribay said. "With the new conditions we are able to obtain much better lysis results in a broader range of cell types increasing the number of applications the kit is suitable for."

Sygnis, which claims headquarters in both Madrid, Spain and Heidelburg, Germany, has about 25 employees spread between its two locations. Among its collaborators in product development research are University Hospital of Hamburg-Eppendorf in Hamburg, the Hospital Clinico San Carlos in Madrid, and the Hospital Universitario Santiago de Compostela, Spain.

The firm has been steadily expanding over the past two years and has inked distribution deals with several companies located around the globe, including D-Mark Biosciences in Canada, Nanodigmbio in China, Funakoshi in Japan, Welgene in Taiwan, GeneWorks in Australia, and both Mayflower Bioscience and Lucigen in the US, among others. It also recently acquired Expedeon, a proteomics reagent company.

Sygnis believes the main competition for its products comes from Qiagen, GE Life Sciences, and Rubicon Genomics, all of which offer products in the DNA amplification, DNA sequencing, and proteomics space.

However, the company hopes its acquisition of Expedeon will allow its products to gain a stronger hold in the US, UK, and Singapore markets, where it currently doesn't have a strong presence. Currently, Expedeon generates approximately 30 percent of its revenues from US sales and has a strong sales presence in the UK and Singapore, according to Viribay.

The acquisition of Expedeon will allow Sygnis to cover a much broader market segment, while offering its current customers a larger portfolio of products, Viribay said. "We like to see it as a 'from single-cell genome to a whole-proteome' approach" to the market, he added.