NEW YORK (GenomeWeb) – Singapore-based digital PCR platform manufacturer JN MedSys has been growing its business with expansion plans for China, the UK, and the US.
The firm hopes to carve out a niche in these markets for its proprietary "chip-in-a-tube" digital PCR system, which it believes combines the advantages of existing droplet- and chip-based dPCR systems in a single platform, product manager Erin Zhang said in an email.
Called Clarity, the system combines a tube strip — a set of connected PCR tubes — with chip-based partitioning, such that dPCR mix is rapidly subdivided into 10,000 partitions by a high-density chip embedded within each tube. JN MedSys is the only firm offering this "chip-in-a-tube" digital PCR technology, Zhang said.
Clarity consists of three instruments; the auto loader, sealing enhancer, and reader. The auto loader allows users to load and partition samples onto the chips within the tube strips. The partitions are then stabilized by the sealing enhancer, which employs a proprietary method to increase the separation between adjacent partitions when subsequently filled with a sealing fluid, Zhang said.
After this, a thermal cycling step can be done on a conventional thermal cycler, which gives customers the flexibility to use existing instruments in their laboratories. Fluorescent signals on the chips are then detected by the reader, and DNA copy number concentration of the sample is analyzed using Clarity software.
Compared to other digital PCR methods, Zhang said the Clarity system provides certain advantages in throughput and reaction times. "Users can perform 96 reactions in one run, in under four hours, which is one of the fastest among digital PCR methods," she said, adding that "other products can do about eight or 16 reactions in one whole day." The firm attributes its higher throughput to a fast and easy workflow, and the tube-strip design also enables samples to be analyzed in a closed environment, minimizing the risk of contamination, Zhang said.
While she declined to provide specific costs of the platform and consumables, she said both are "quite affordable," and that Clarity is "at least half the price" of the market-leading systems.
In a study published this month in Analytical and Bioanalytical Chemistry, researchers at JN MedSys and Singapore Polytechnic's Centre for Biomedical and Life Sciences demonstrated linearity across a range of over four orders of magnitude for absolute quantification of the RNase P gene from human genomic DNA using the Clarity system. They further demonstrated the platform is compatible with different master mixes, and compared performance of Clarity on a set of DNA reference materials to the Bio-Rad QX-100 droplet dPCR system, showing a less than 10 percent difference in results compared to the certified concentration, and less than the Bio-Rad system in their hands.
Two additional papers were recently published using the technology. In Scientific Reports last year researchers used Clarity to quantify Epstein-Barr virus cell-free DNA in patients undergoing treatment for nasopharyngeal carcinoma, comparing the method to circulating tumor cell enumeration. The study suggested EBV cfDNA outperforms CTC enumeration in correlation with clinical outcomes of nasopharyngeal carcinoma patients undergoing treatment.
And a study published late last year in Environmental Science and Pollution Research by researchers at the King Abdullah University of Science and Technology in Saudi Arabia also showed the Clarity system could be used for species-targeted digital PCR to detect pathogens in treated wastewater.
JN MedSys recently signed an agreement with LMS in Japan to distribute Clarity there. Zhang said the firm has also inked a partnership with Cold Spring Biotech for distribution in China and Taiwan, as well as one with BioD in Korea, and Research Biolabs in Singapore and Malaysia, all in order to expand the firm's distribution network in the Asia-Pacific region. To support these new partnerships, the company plans to set up an office China this month, with a small team of about five technical support staff.
In addition, to support its US expansion, JN MedSys will be setting up an office in the San Jose, California area within the next month. "We are starting with a small team of not more than 10 people and they will mainly be supporting installations at early users, as well as reaching out to new ones," Zhang said. The firm already has a team in the UK supporting early users there. "We hope to build up this team gradually over this year, as we have a number of users and collaborations lined up," she said.
The company, which was founded in 2010 and is primarily funded by private investors, is also aware that the diagnostics market is growing rapidly worldwide, Zhang said, driven by the increasing focus on precision medicine. "We envisage Clarity dPCR playing a key role in supporting oncology and infectious disease diagnosis," she said, and the firm also plans to commercialize diagnostic kits. JN MedSys is also "always on a lookout for partners to develop and commercialize diagnostic kits to be used clinically," she added.
In the future, the firm sees the strong clinical utilities of digital PCR and has plans to obtain the required regulatory approvals to bring Clarity, which is now used as a research tool, into key IVD markets. "We intend to bring the system into the US as we regard it as an important market," Zhang said.