naica® system

dPCR kits

EGFR 6-color Crystal Digital PCR™ Kit

The EGFR 6-color kit allows for the detection and quantification of up to 32 somatic EGFR mutations in exons 18, 19, 20, and 21 associated with non-small cell cancer (NSCLC). The kit can be used on cell-free DNA (cfDNA) extracted from plasma samples.

EGFR 6-color Crystal Digital PCR™ kit detection design. TaqMan™ probe positions on each exon and fluorescent color code are noted. In the table, LoB and LoD of the EGFR 6-color Crystal Digital PCR™ kit determined following the CLSI EP17-A2 standard (concentrations in cp/μL). 

The IDENTIFY kit line

The IDENTIFY kit line allows to detect multiplexed mutation panels using a fully validated, specific and sensitive Crystal Digital PCR™ solution: the naica® system, both on circulating cell-free DNA from liquid biopsies and tumor DNA from solid biopsies.

• IDEGFR, detection of EGFR mutations in non-small cell lung cancer (NSCLC)
• IDNRAS, detection of NRAS mutations from tumor DNA
• IDKRAS, detection of KRAS mutations from tumor DNA
• IDBRAF, detection of BRAF mutations at position V600
• IDPIK3CA, detection of PIK3CA mutations from tumor DNA
• IDIDH1-2, detection of IDH1 and IDH2 mutations from tumor DNA
• IDH3F3A, detection of H3F3A mutations from tumor DNA
• IDBRAF-CNS, detection of BRAF mutations in brain tumors
• IDFGFR1-CNS, detection of FGFR1 mutations in brain tumors

SARS-CoV-2 multiplex Crystal Digital PCR™ Kit

After proof-of-concept studies in China, a highly sensitive SARS-CoV-2 detection kit was developed, intended for the qualitative detection of reported conserved viral nucleic acid sequences, Nucleoprotein N (FAM) and ORF1ab (HEX), using Crystal Digital PCR™. This kit is designed to offer an advantage over the conventionally used qPCR by detecting low concentration targets in a large sample volume where qPCR was leading to unreliable result interpretation due to high Ct values. The SARS-CoV-2 multiplex Crystal Digital PCR™ kit has emerged as a powerful tool and a powerful alternative to the traditional qPCR technique. Test results indicate a robust and specific detection of SARS-CoV-2 sequences down to 5 copies per 25µl reaction (equivalent to 0.2 cp/µl) for ORF1ab and for Nucleoprotein N: down to  7 copies per 25µl reaction (equivalent to 0.28 cp/µl)). The kit includes reagents, Sapphire chips, and COVID-19 positive and negative controls.

Performance evaluated by CNR Pasteur Institute