Stilla Technologies launches the world’s first six-color digital PCR instrument

Key applications include oncology, infectious disease and food testing

Stilla Technologies, a provider of digital PCR (dPCR) solutions for high-precision genetic analysis, launched the world’s first six-color digital PCR instrument, the six-color Prism. The instrument expands the multiplexing capabilities of the company’s digital PCR platform, the Naica™ System. The instrument has been validated for use with a six-color lung cancer panel for EGFR mutation quantification, for liquid-biopsy monitoring in breast and rectal cancer and for detecting and quantifying genetically modified organisms in the food supply. Applications for the six-color Prism include oncology, infectious disease, gene therapy, disease monitoring and food testing.

With an original three-color and now six-color detection capability, the company’s Naica System is capable of characterizing multiple types of nucleic acids, making it a preferred technology for precision medicine research, companion diagnostics and disease monitoring. The Naica System is a highly sensitive digital PCR solution that runs on the company’s next–generation genetic testing and nucleic acid quantification technology, Crystal Digital™ PCR. Its ease of use and fastest time to results — in under three hours — set this innovative technology apart on the digital PCR market.

Stilla was the first company to introduce three-color target multiplexing to digital PCR back in 2016, and we are excited to bring the world’s first six-color instrument to the market,” said Rémi Dangla, Ph.D., Stilla’s CEO, co-founder and inventor of the company’s technology. “With six-color multiplexing, the Naica™ System meets the demands of high-precision genetic testing applications — especially in the field of personalized medicine — while still being ultrafast and easy-to use. In addition to applications in oncology and food testing, we expect that the global response to COVID-19 will increase the need for multiplexed assays to differentiate respiratory infections — something the six-color Prism can accomplish with greater sensitivity than other PCR systems.”

Key features of the six-color Prism instrument include:

  • Fast time to results — under three hours
  • No change to Naica System workflow
  • Compatible with current Stilla consumables
  • Now available for order

Stilla published the first successful implementation of its Crystal Digital PCR workflow in six colors in a proof-of-concept study, “EGFR C797S, EGFR T790M and EGFR sensitizing mutations in non-small cell lung cancer revealed by six-color crystal digital PCR,” published in Oncotarget in early 2019. The detection of mutations in the gene EGFR is critical for therapy management of non-small cell lung cancer (NSCLC) patients, and noninvasive blood-based monitoring of these mutations will facilitate life-saving personalized treatment. dPCR has emerged as an extremely sensitive method to detect rare genetic mutations; however, until now, the number of mutated regions that can be simultaneously detected has limited its utility in noninvasive screening. In the proof-of-concept six-color dPCR study, investigators developed a single assay enabling the detection and quantification of 19 of the most prevalent EGFR mutations, covering 90% of actionable EGFR mutations. Stilla’s six-color dPCR assay was able to detect mutations with a sensitivity of one mutant allele in a background of 1,000 wild-type alleles (0.1%).

Recently Stilla’s R&D team has replicated this approach to high-plex liquid biopsy testing with six-color Crystal Digital PCR panels for breast cancer and rectal cancer. Both assays will be tested in clinical trials due to start in 2020 as part of the EU Horizon 2020 LIMA project.

With our study, we demonstrated that six-color Crystal Digital PCR assay is a robust and flexible solution for the monitoring of EGFR mutations,” said Allison Mallory, Ph.D., Director of Molecular Biology Research & Development at Stilla Technologies. “We are confident that our new multiplexing system will enable the sensitive and simultaneous detection of a wide range of clinically relevant disease-associated mutations, essential to the critical task of detecting the presence of cancer and monitoring response to treatment.

Stilla will present a webinar on the company’s six-color Crystal Digital PCR System in collaboration with GenomeWeb & the National Institute of Biology, Slovenia, on Thursday, June 11 at 11 a.m. EDT/5 p.m. CEST. The webinar will highlight a set of applications poised to benefit significantly from the increased multiplexing and high sensitivity of six-color digital PCR. Alexandra Bogozalec will detail how the NIB has capitalized on the high-plex capacity of six-color Crystal Digital PCR™ to simplify the current time-consuming GMO-quantification workflow as well as how they have quantified a set of genetically modified soybean lines at low-target concentrations. The webinar will also describe how the sensitivity of six-color Crystal Digital PCR™ benefits oncology applications. Stilla will present results on patient samples for non-small cell lung cancer (NSCLC), rectal cancer and breast cancer and show how six-color digital PCR enables efficient therapeutic monitoring and early detection of treatment resistance through noninvasive liquid biopsy.

Source: https://www.prnewswire.com/

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