Fungi
Thanks to many years of experience in medical diagnostics, we market and distribute innovations in fungal, bacterial and viral diagnostics to the healthcare sector.
Our rapid diagnostic tests are highly reliable and fit perfectly into current treatments. They can reduce the rate of drug-resistant infections by promoting a new guided diagnostic approach. This is achieved while offering clear economic and clinical benefits to hospitals, doctors and patients. Also, we are studying and developing a new diagnostic-driven approach to addressing fungal infections.
CandID
CE IVD multiplex qPCR test designed to detect genomic DNA of 6 commonly isolated Candida species; C. albicans, C. glabrata, C. parapsilosis, C. krusei, C. dubliniensis and C. Tropicalis. Invasive candidiasis is the most common fungal disease among hospitalized patients in the developed world, and candidemia is often cited as the fourth most common bloodstream infection within intensive care units. CandID is validated on DNA extracted from fungal cultures and from clinically relevant matrices (plasma, serum and whole blood). The kit is compatible with the most common DNA extraction and Real-Time PCR tools.
- Sensitivity <1 Candida genome
- Detection in a range of 6 orders of magnitude (n° target from <1 to 10^6)
- Result in <1h from DNA extraction.
AurisID
CE IVD Real-Time PCR test capable of rapidly detecting of Candida auris genomic DNA.
Candida auris, species of the genus Candida, is a globally emerging multidrug-resistant pathogen causing nosocomial infections. Since it was first isolated, C. auris has been associated with bloodstream and wound infections and has caused hospital outbreaks in several countries. C. auris is commonly resistant to the first-line antifungal drug fluconazole, and multi-resistant strains have been reported. AurisID has been validated on DNA extracted from fungal culture and blood samples (serum, plasma, whole blood) as well as directly from surveillance swab transport fluid without the need for a DNA extraction step. The kit is compatible with the most common DNA extraction and Real-Time PCR tools.
- Sensitivity <1 Candida auris genome;
- Detection in a range of 6 orders of magnitude (n° target from <1 to 10^6);
- Result in <1h without DNA extraction.
AspID
CE IVD multiplex qPCR test designed to detect genomic DNA of clinically relevant Aspergillus species. AspID® also allows discrimination of infections by A. terreus, a fungus intrinsically resistant to amphotericin B. Aspergillus specific qPCR assays have been proposed as alternatives to conventional diagnostic procedures for invasive aspergillosis, where early diagnosis and timeliness of therapeutic treatment are critical for patient survival. The kit is validated on DNA extracted from serum, bronchoalveolar lavage (BAL) and fungal cultures. The kit is compatible with the most common DNA extraction and Real-Time PCR tools.
- Sensitivity <1 genome of Aspergillus spp.
- Detection in a range of 6 orders of magnitude (n° target from <1 to 10^6)
- Result in <1.5h from DNA extraction.
PneumID
CE IVD multiplex qPCR test designed to detect Pneumocystis jirovecii genomic DNA. P. jirovecii is a common cause of pneumonia in people with compromised immune systems. This organism cannot be cultured in vitro and consequently real-time PCR is indicated among the conventional diagnostic procedures for Pneumocystis pneumonia. PneumID® is validated on DNA extracted from fungal cultures and clinically relevant respiratory (BAL) samples. The kit is compatible with the most common DNA extraction and Real-Time PCR tools.
- Sensitivity <1 P. jirovecii genome.
- Detection in a range of 6 orders of magnitude (n° target from <1 to 10^6)
- Result in <1h from DNA extraction.
AspLFD (Aspergillus Lateral-Flow Device)
A rapid chromatographic immunoassay for the qualitative detection of Aspergillus in human serum and BAL, for use as an aid in the evaluation of patients with suspected invasive pulmonary aspergillosis (IPA). AspLFD uses a monoclonal Ab that detects antigenic mannoproteins produced by the fungus during active growth.
- From serum with a simple pre-treatment;
- Flexibility of use: Non-hemorrhagic BAL requires no pretreatment;
- Reduces time: results in 15-40 minutes;
- Highly sensitive: proven efficacy in the diagnosis of IPA
- Highly specific: the target is a specific antigen of Aspergillus spp.
Ticks and tropical fevers
Prevention of ticks and tropical fevers
Summer is coming. It is necessary to have diagnostic kits to detect arbovirus and other diseases transmitted by vectors such as ticks and mosquitoes.
Already in June 2018, the Ministry of Health issued the National Surveillance Plan and informed that between 2000 and 2016 alone, 456 laboratory-confirmed TBE cases had been reported.
However, the data is on the rise. The increase in temperatures and, more specifically, the tropicalization of Europe, is increasing the risk of local development of infectious and tropical diseases. Italy is among the countries that in recent years have had a greater increase in diseases transmitted by ticks and mosquitoes. Also looming is the specter of the arrival of Aedes aegypti, the tropical mosquito that transmits Yellow Fever and Dengue.
Detecting the viral genome by RT-qPCR is highly specific. This is of fundamental importance considering that the interpretation of the results of serological tests is often made difficult by the cross-reactivity of the antibodies produced against arboviruses.
- many of which are unmatched on the market
- CE-IVD marked
- multiplex
- open to the most common instruments
- most of them with the same thermal profile
- Tick Borne Encephalitis virus
- Tick Borne Encephalitis virus and West Nile virus (multiplex)
- Zika virus, Chikungunya virus, Dengue viruses 1-4 and Yellow Fever virus (multiplex).
- Coxiella burnetii
- Babesia divergens, Babesia microti, Babesia spp EU1
- chaffeensis, E. ewingii, Anaplasma phagocytophilum
- Rickettsia spp
- Borrelia burgdorferi (sensu lato)
- Borrelia burgdorferi (sensu lato) and Rickettsia (multiplex).
Neonatal Screeningfor SMA, XLA and SCID
SPOT-it TREC, KREC & SMN1Kit per lo screening di SMA (Atrofia Muscolare Spinale), SCID (Immunodeficienza Combinata Grave) e XLA (Agammaglobulinemia)Con estrazione del DNA inclusaCon sistema di automazione brevettato e ottimizzato anche per laboratori di dimensioni ridotte e bassi numeri di campioni.
SPOT-it TREC & SMN1 Screening Kit
The CE IVD kit is intended for simultaneous screening for Severe Combined Immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) in newborns. SCID screening is performed by semi-quantification of T-cell receptor excision circle (TREC) and SMA screening by a qualitative detection of exon 7 of the SMN1 gene. DNA is extracted from fresh, dried blood spots (DBS) sampled on filter paper. The SPOT-it Screening Kit use qPCR where target DNA sequences are amplified by cycling between different temperature steps and where the amplification is monitored during each cycle using a fluorescent reporter.
- Markers: TREC, SMN1 and Beta-actin (ACTB)
- Specificity: SCID Screening 99,57% - SMA Screening 100%
- Sensitivity: SCID Screening 100% - SMA Screening 100%
- Format:
- 1-2020-TS: Reagents for 82 samples in one 96-well plate (12 standard, 82 sample and 2 control card wells)
- 12-2020-TS: Reagents for 984 samples in twelve 96-well plates (12 standard, 82 sample and 2 control card wells per plate).
SPOT-it TREC, KREC & SMN1 Screening Kit
The CE IVD kit is intended for newborn screening for severe combined immunodeficiency (SCID), agammaglobulinemia (XLA) and Spinal Muscular Atrophy (SMA) in newborns. SCID screening is performed by semi-quantification of T-cell receptor excision circle (TREC), XLA screening by kappa-deleting recombination excision circles (KREC) and SMA screening by a qualitative detection of exon 7 of the SMN1 gene. DNA is extracted from fresh, dried blood spots (DBS) sampled on filter paper. The SPOT-it Screening Kit use qPCR where target DNA sequences are amplified by cycling between different temperature steps and where the amplification is monitored during each cycle using a fluorescent reporter.
- Markers: TREC, KREC and SMN1
- Specificity: SCID Screening 99,57% - XLA Screening 99% - SMA Screening 100%
- Sensitivity: SCID Screening 100% - XLA Screening 99% -SMA Screening 100%
- Format:
- 1-2020-TKS: Reagents for 82 samples in one 96-well plate (12 standard, 82 sample and 2 control card wells)
- 12-2020-TKS: Reagents for 984 samples in twelve 96-well plates (12 standard, 82 sample and 2 control card wells per plate).
Bacteria
EurobioPlex Leptospira
The CE IVD kit uses transcription-real time polymerase chain reaction (RT-PCR) amplification and is designed for the qualitative detection of Leptospira by amplification of nucleic acids of this pathogen in a nucleic acid extract. This test is indicated to diagnose the occurrence of infection by Leptospira in humans or complement a proven or indeterminate diagnosis. The EurobioPlex Leptospira has been validated on plasma and urine.
- CFX96TM Real Time PCR detection system (Bio-Rad) with analysis on CFX Manager v 3.1 (Bio-Rad)
- LightCycler®480 Instrument II (Roche) with analysis on LightCycler® 480 software v1.5 (Roche)
- T-COR 8TM-IVD (Tetracore Inc.) with T-COR 8 SmartCTTM (autov1) Software
- Limit of detection: 5 copies/μL
- Specificity: > 99%
- Sensitivity: > 99%
Oncology
We are constantly committed to supporting the use of personalized medicine in order to improve clinical decision based on genomic data, thereby increasing the quality of life of people suffering from genetic and oncological diseases.
We offer a wide range of tests using Real-Time PCR, fragment analysis and NGS to meet the diverse needs of laboratories and patients. Our suppliers have years of experience in the field of genetics and oncology and their products are routinely used in prestigious institutions in Europe.
Kit screening BCR-ABL1
Qualitative analysis CE IVD Real-Time PCR that detects the presence of the most common variants of the BCR-ABL1 rearrangement (M-BCR-ABL1 (p210) and m-BCR -ABL1 (p190)), and the presence of the ABL1 reference gene.
Kit screening PML-RARA
CE IVD quality test that allows to determine the presence of the three possible variants (bcr1, bcr2 and bcr3) of the rearrangement t (15, 17) (q22; q21) of PML-RARA in a single PCR reaction.
Kit MPL
CE IVD multiplex test that amplifies the W515L (NM_005373.2: c.1544G> T) and W515K (NM_005373.2: c.1543_1544delTGinsAA) mutations in the MPL gene.
Kit NPM1
CE IVD multiplex test that allows to simultaneously amplify the most frequent insertion variants (subtypes A, B and D) in exon 12 of the NPM1 gene.
Kit CALR
CE IVD qualitative analysis test that evaluates the insertion or deletion mutations (INDEL) in exon 9 of the CALR gene in relation to the size of the amplification fragments obtained.
Kit FLT3
Qualitative CE IVD analysis test that evaluates the ITD mutations of the FLT3 gene in relation to the size of the amplification fragments obtained.
Action OncoKitDX
The CE IVD kit is compatible with the following tools: Illumina NextSeq500, Illumina NextSeq2000, Illumina HiSeq, Illumina NovaSeq. The protocol has been validated and automated on the Agilent Magnis library preparation tool.
Characteristics:
- Dynamic kit that updates the target genes of the panel according to scientific evidence.
- Detection of SNV and INDEL.
- Analysis of mergers and rearrangements (SV) related to targeted therapies.
- Detection of microsatellite instability (MSI).
- CNV detection of selected genes, as well as losses and gains throughout the genome.
- Pharmacogenetic analysis associated with the response to chemotherapy treatments.
- Molecular marking with UMI that increases the sensitivity of bioinformatics analysis.
- Analysis software included: Data genomics.
- STID: Integrated sample identification system for traceability.
- Coverage: 96.2% of the bases covered at a depth of 100X.
- Uniformity: 95.7% of bases covered at > 20% of median coverage.
- Sensitivity: > 99%.
- Specificity: > 99%.
- The detection limit (LOD) for SV, SNV and INDEL is 5%.
- The detection limit for CNV is 3 copies for duplications and 1 copy for deletions, provided that the infiltration of the tumor with non-cancer cells is not more than 30%.
Target genes:
SNVs and INDELs: AKT1 *, ALK, ARID1A, ATM, ATRX, BAP1, BRAF, BRCA1, BRCA2, CDH1, CHEK2, CTNNB1, EGFR, ERBB2, ESR1, FGFR1, FGFR4, GNA11, GNAIST1, H3A, HIST1H3A, HIST1H3H, IDH1, IDH2, KIT, KRAS, MAP2K1, MET, MLH1, MSH2, MSH6, MTOR, MYC, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PBRM1, PDGFRA, PIK3CA, PMS2 + 5’UTR, PTEN, POLD1, POLE , RET, ROS1, SDHA, SDHB, SDHD, TERT + 5’UTR, TSC1*, TSC2*, TP53 and VHL.
* Hotspot sequencing
SVs: ALK (intron 19), ATP1B1 (introns 3 and 4), BRAF (introns 7, 8, 9 and 10), EGFR (introns 7, 23, 24 and 25), ETV6 (introns 4 and 5), FGFR2 (intron 17 and 3’UTR region), FGFR3 (intron 17 and 3’UTR region), NTRK1 (introns 8, 9, 10, 11 and 12), NTRK2 (introns 10 and 12), RET (introns 9, 10 and 11 ) and ROS1 (introns 31, 32, 33, 34 and 35).
Haematology OncoKitDX
The CE IVD kit is compatible with the following tools: Illumina NextSeq500, Illumina NextSeq2000, Illumina HiSeq, Illumina NovaSeq. The protocol has been validated and automated on the Agilent Magnis library preparation tool.
Characteristics:
- Dynamic kit that updates the target genes of the panel according to scientific evidence.
- Detection of SNV and INDEL.
- It allows the detection of internal tandem duplications (ITD) in FLT3, present in 20-27% of AML.
- Analysis of mergers and rearrangements (SV) related to targeted therapies and diagnosis of entities recognized by the WHO.
- CNV detection of selected genes, as well as losses and gains throughout the genome, allowing the detection of alterations such as hypo and hyperploidy, gains or losses of complete chromosomes (+8, -7, -17) or chromosomal regions (5q, 7q, 11q), for example.
- Pharmacogenetic analysis associated with response to chemotherapy treatments and offering optional guidance for dose adjustment in each case.
- Molecular marking with UMI that increases the sensitivity of bioinformatics analysis.
- Analysis software included: Data genomics.
- STID: Integrated sample identification system for traceability.
- Coverage: 96,3% of the bases covered at a depth of 100X.
- Uniformity: 98,4% of bases covered at > 20% of average coverage.
- Sensitivity: > 99%.
- Specificity: > 99%.
- The detection limit (LOD) for SV, SNV and INDEL is 2%.
- The limit of detectability of CNVs, compared to total copies of a sample, has been set at 20% in case of loss and 10% for gains from copying.
Target genes:
SNVs and INDELs: ARID5B, ASXL1, ASXL2, ATRX, BCOR, BCORL1, BLNK, BRAF, CALR, CBL, CDKN2A, CDKN2B, CEBPA, CHIC2, CREBBP, CRLF2, CSF3R, CSNK1A1, CUX1, DDX41, DNT300, DDT300, ETNK1, ETV6, EZH2, FBXW7, FLT3, GATA1, GATA2 (and intron 4), GATA3, HAVCR2, IDH1, IDH2, IKZF1, IL7R, JAK1, JAK2, JAK3, KIT, KMT2A, KMT2C, KFRAS1, KFRAS1, MPL, NFE2, NOTCH1, NPM1, NR3C1, NRAS, P2RY8, PAX5, PHF6, PIGA, PPM1D, PTEN, PTK2B, PTPN11, RAD21, RB1, RUNX1, SETBP1, SF3B1, SH2B3, SMC1A, SMC3, SRP72, STAG1B2, STAG1B2, STAG1B2 , TET2, TP53, TYK2, U2AF1, WT1, ZRSR2.
SVs: ABL1 (5’UTR region, introns 1, 2 and 3), ABL2 (introns 3, 4 and 5), BCR (introns 6, 13, 14, 15 and 19), CBFA2T3 (introns 10 and 11 and region 3 ‘UTR), CBFB (intron 5), CSF1R (intron 11 and 13), EPOR (intron 7 and CDS exon 8), ETV6 (introns 2, 3, 4 and 5), FGFR1 (introns 7, 8, 9 and 10 ), FUS (introns 5, 6, 7, 8, 9, 11 and 14), JAK2 (introns 8, 9, 10, 11, 15, 16, 17, 18 and 19), KMT2A (introns 6, 7, 8 , 9, 10, 11, 15, 22 and 29), MEF2D (introns 5 and 6), MNX1 (introns 1 and 2), MYH11 (intron 7), NPM1 (intron 4), NUP214 (introns 1, 9, 16 and 17), NUP98 (introns 10, 11, 12, 13 and 14), PDGFRA (introns 11 and 12), PDGFRB (introns 9, 10, 11 and 12) , RARE (intron 2), RBM15 (intron 1), RUNX1 (intron 6), SET (intron 7), STIL (5’UTR region), TAL1 (intron 3) and TCF3 (introns 13, 14, 15, 16 and 17).
Hereditary OncoKitDX
The CE IVD kit is compatible with the following tools: Illumina iSeq, Illumina MiSeq, Illumina NextSeq500, Illumina NextSeq2000, Illumina HiSeq, Illumina NovaSeq. The protocol has been validated and automated on the Agilent Magnis library preparation tool.
Characteristics:
- Dynamic kit that updates the target genes of the panel according to scientific evidence.
- Type of mutations analyzed: SNV, INDEL, CNV, ALU and other large insertions
- Yield: 99,5% of the bases covered at a depth of 50X
- Uniformity: 99,2% of bases covered at > 20% of average coverage and 90% of bases covered at > 50% of average coverage.
- Sensibility: > 99,9%
- Specificity: > 99,9%
Target genes: 50
APC, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, FAM175A (ABRAXAS1), FH, KIF1B, MAX, MEN1, MET, MLH1, MLH3, MRE11, MSH2, MSH3, MSH6, MUTYH, NBN, NF1, NTHL1, PALB2, PIK3CA, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, RB1, RET, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, STK11, TM TP53, VHL, XRCC2
BRCAaccuTest PLUS
The CE IVD kit is intended for the analysis of the BRCA1 and BRCA2 genes using the Next Generation Sequencing Method (NGS), which analyzes genomic DNA derived from blood or FFPE tissue.
It is used in patients with breast and ovarian cancer, patients with HBOC (Hereditary Breast and Ovarian Cancer Syndrome) and for the family history or age of breast cancer incidence.
- Format: 12 or 24 test
- Compatible with: Illumina/MiSeq, MiSeq R
- Analysis software included: CE IVD NGeneAnalysis
- Coverage: 99,9% of the bases covered at a depth of 200X in germline samples and 99,9% of bases covered at a depth of 1000X in somatic samples
- Uniformity: 100% of the bases covered at > 20% of the average coverage
- Sensibility: > 95%
- Specificity: > 95%
HEMEaccuTest DNA
The CE IVD kit is intended for molecular genetic test of multiple genes related hematologic malignancy as Acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic/myeloproliferative neoplasm, multiple myeloma, lymphoma. This kit can qualitatively analyze multiple gene variants in genomic DNA isolated from peripheral blood, bone marrow, and lymph nodes with NGS.
- Format: 48 or 96 test
- Compatible with: Illumina/MiSeq, MiSeq Dx
- Analysis software included: NgeneAnalysis (CE)
- Limit of Detection: SNV 1% - INDEL 2%
- Accuracy: PPA 100% - PPV 100%
- Sensibility: 100%
- Specificity: 100%
Target genes: 108
ABL1, ABL2, AKT1, ALK, ANKRD26, ASXL1, ATM, BCL2, BCL6, BCOR, BCR, BIRC3, BRAF, CALR, CBFB, CBL, CCND1, CDKN2A, CDKN2B, CEBPA, CREBBP, CRLF2, CSF1R, CSF3R, CXCR4, DDX41, DEK, DHX15, DKC1, DNMT3A, EBF1, EP300, EPOR, ETNK1, ETV6, EZH2, FBXW7, FGFR1, FIP1L1, FLT3,GATA1, GATA2, GATA3, IDH1, IDH2, IKZF1, IKZF2, IKZF3, IL3, IL7R, JAK1, JAK2, JAK3, KDM6A, KIT, KMT2A, KRAS, MECOM, MGA, MKL1, MLLT3, MPL, MTCP1, MYC, MYD88, MYH11, NF1, NOTCH1, NPM1, NRAS, NTRK3, NUP214, PAX5, PBX1, PCM1, PDGFRA, PDGFRB, PHF6, PML, PRPF8, PTPN11, RAD21, RARA, RB1, RBM15, RUNX1, RUNX1T1, SETBP1, SF3B1, SH2B3, SMC1A, SMC3, SRSF2, STAG2, STAT3, TAL1, TCF3, TERC, TERT, TET2, TLX1, TLX3, TP53, TYK2, U2AF1, WT1, ZBTB7A, ZRSR2.
HEMEaccuTest RNA
The RUO kit is intended for comprehensive detection of fusion transcripts and gene expression levels relevant in hematologic malignancies. This test use peripheral blood, bone marrow, and lymph nodes, as an aid in the differential diagnosis of hematologic malignancy.
Ultimately, HEMEaccuTest RNA is for a purpose of appropriate classification and differential diagnosis through qualitative analysis of hematologic malignancy.
- Format: 48 or 96 test
- Compatible with: Illumina/MiSeq, MiSeq Dx
- Analysis software included: NgeneAnalysis (CE)
Target genes: 53:
ABL1, ABL2, BAALC, BCR, CBFB, CCND1, CCND2, CCND3, CRBN, CRLF2, CSF1R, DEK, ETV6, FGFR1, FGFR3, FIP1L1, FUS, GATA2, IGH, IL2RB, IL3, JAK2, KMT2A, MAF, MAFA, MAFB, MECOM, MKL1, MLF1, MLLT3, MYH11, NSD2, NUP214, NUP98, PBX1, PCM1, PDGFRA, PDGFRB, PHB, PHB2, PML, RARA, RBM15, RUNX1, RUNX1T1, TCF3, TYK2, WT1, GUSB*, HBS1L*, HPRT1*, SDHA*, TBP*.
* Genes in bold characters are housekeeping genes
SOLIDaccuTest DNA
The CE IVD kit is an excellent tool to explorer variants associated with solid tumors using a comprehensive method of next-generation sequencing (NGS). It reflects the latest research trends and is optimized for the medical purpose by selecting essential genes of solid tumors including lung, colon, breast, skin brain, gastric, ovarian cancers, etc.
- Format: 48 or 96 test
- Compatible con: Illumina/MiSeq, MiSeq Dx
- Analysis software included: NgeneAnalysis (CE)
Target genes: 84
AKT1, ALK, APC, AR, ARAF, ARID1A, ATM, ATRX, BRAF, BRCA1, BRCA2, CCND1, CCNE1, CDH1, CDK4, CDK6, CDKN2A, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, ERBB4, ESR1, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FHFOXA1, GATA3, GNA11, GNAQ, GNAS, H3F3A, HRAS, IDH1, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MAP2K1, MDM2, MET, MLH1, MSH2, MSH6, MTOR, MYC, MYCN, NF1, NOTCH1, NRAS, PALB2, PDGFRA, PIK3CA, PIK3R1, PMS2, POLE, PTEN, RAC1, RAF1, RB1, RET, RHOA, RICTOR, RIT1, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMO, SPOP, SRC, STK11, TGFBR2, TP53, TSC1, TSC2, VHL.
SOLIDaccuTest RNA
The RUO kit is a cost-effective and beneficial tool to detect gene fusions in multiple types of solid tumors, regardless of origin using a comprehensive method of next-generation sequencing (NGS). In addition, SOLIDaccuTest RNA is designed by selecting major genes of solid tumors including lung, colon, breast, skin, brain, ovarian cancers etc. Therefore, the ultimate purpose of SOLIDaccuTest RNA is detecting fusions in genes related to various solid tumors and providing supportive evidence for the clinical utility of prognosis, diagnosis or therapeutic implications.
- Format: 48 or 96 test
- Compatible with: Illumina/MiSeq, MiSeq Dx
- Analysis software included: NgeneAnalysis (CE)
Target genes: 29
AKT3, ALK, BRAF, CLDN18, EGFR, ERAS, ERG, ESR1, ETV1, ETV4, ETV5, FGFR1, FGFR2, FGFR3, MET, MITF, NRG1, NTRK1, NTRK2, NTRK3, RAF1, RET, ROS1, RSPO2, RSPO3, TFE3, TFEB, BRCA1, BRCA2.
SOLIDaccuTest DNA HRD
The RUO kit is an excellent tool to explorer genetic variants associated with solid tumors using a comprehensive method of next-generation sequencing (NGS). It reflects the latest research trends and is optimized for the medical purpose by selecting essential genes of solid tumors including lung, colon, breast, skin, brain, gastric, ovarian cancers etc. Therefore, the ultimate purpose of SOLIDaccuTest DNA HRD is to detect genetic mutations in various solid tumors.
- Format: 96 test
- Compatible with: Illumina/MiSeq, MiSeq Dx
- Analysis software included: NgeneAnalysis (CE)
Target genes: 111
AKT1, ALK, APC, AR, ARAF, ARID1A, ATM, ATR, ATRX, BARD1, BLM, BRAF, BRCA1, BRCA2, BRIP1, CCND1, CCNE1, CDH1, CDK12, CDK4, CDK6, CDKN2A, CHEK2, CTNNB1, DDR2, EGFR, EMSY, ERBB2, ERBB3, ERBB4, ERCC1, ESR1, EZH2, FANCA, FANCD2, FANCF, FANCI, FANCM, FBXW7, FGFR1, FGFR2, FGFR3, FHFOXA1, GATA3, GNA11, GNAQ, GNAS, H3F3A, HRAS, IDH1, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MADD2LD, MAP2K1, MDM2, MET, MLH1, MRE11, MSH2, MSH6, MTOR, MYC, MYCN, NBN, NF1, NOTCH1, NRAS, PALB2, PDGFRA, PIK3CA, PIK3R1, PMS2, POLE, PTEN, RAC1, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAF1, RB1, RBBP8, RET, RHOA, RICTOR, RIT1, SLFN11, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMO, SPOP, SRC, STK11, TGFBR2, TP53, TP53BP1, TSC1, TSC2, VHL, XRCC1, XRCC5, XRCC6.
ONCOaccuPanel
The RUO kit is a comprehensive next-general sequencing panel that can be capable of genomic profiling of solid tumor samples. This product can also support identifying relevant variants related to various solid tumor types including lung, breast, ovarian, brain, colorectal, stomach cancer, etc.
Is a reagent kit that prepares NGS libraries in a capture-based hybridization method that selects and amplifies target genes from genomic DNA extracted from formalin-fixed paraffin embedded (FFPE) tissue or non-FFPE samples. Common variants of 344 genes cancer-related can be evaluated using RNA probes in a single assay. It covers 244 genes of the entire coding exon region, 100 genes of the partial exon/hot spot region, and 14 genes of the intronic region.
- Format: 30 or 60 runs
- Compatible with: Illumina/NextSeq, NextSeq550Dx
- Analysis software included: NgeneAnalysis (CE)
- Genes: Target Genes: Total of 344 (244 entire coding exon and 100 partial exon/hot spot).
Partial exon/Hot spot region:
A1BG, ABCC5, ACVR2A, ADAMTS18, ADNP, AKAP7, AP1S1, ARV1, ASH1L, BAX, BTK, CASD1, CBL, CBX4, CCDC73, CD3G, CDH26, CEBPZ, CENPV, CIC, CKAP2, CLOCK, COBLL1, CPEB2, DLC1, DNAH12, DOCK3, DPAGT1, DYNC1I2, EBPL EPPK1, FBXL3, FGFBP1, FMN2, FRG2B, FXR1, GRIN3B, GTPBP2, IMPA1, INO80E, IRS1, KCTD16, KLF4, KNSTRN, KRT32 LIPT1, MADCA, M1MAX, MFSD14A, MFSD4B, MVK, MYO1A, NFE2L2, NIPA2, NNAT, NOS3, NUDT7, OR4M2, PABPC1, PCBP1 PCDHB16, PCMTD1, PPP2R1A, PRAMEF11, PREX2, PRIM2, RAC1, RASA4, RBBP8, RGS12, RHOA, RUFY2, SEC63, SF3B1, SLC23A2, SPRR3, SSTR4, STAMBPL1, STAT3, STAU2, SULT6B1, SYNJ2, TAS2R19, TAS2R31, TCF7L2, TEAD2, TMEM60, TMPRSS13, TPSD1, U2AF1, WDR55, WDR87, ZFP37, ZNF141, ZNF563.
Entire coding sequence:
ABL1, ABL2, ABRAXAS1, AKT1, AKT2, AKT3, ALK*, APC, AR, ARAF, ARID1A, ARID1B, ARID2, ASXL1, ATM, ATR, ATRX, AURKA, AURKB, AURKC, AXIN1, AXL, BAP1, BARD1, BRAF*, BRCA1, BRCA2, BRD2, BRD3, BRD4, BRIP1, CBFB, CCND1, CCND2, CCND3, CCNE1, CD274, CDH1, CDK12, CDK4, CDK6, CDKN1A, CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CHEK2, CREBBP, CRIPAK, CSF1R, CTNNB1, DDR1, DDR2, DDX3X, DNMT3A, DOT1L, DPYD, EGFR*, EPHA3, EPHB4, ERBB2, ERBB3, ERBB4, ERCC2, ERCC4, ERG, ERRFI1, ESR1, ETV1, ETV4, ETV5, ETV6, EWSR1, EZH2, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FNACL, FANCM, FBXW7, FGF4, FGF19, FGFR1, FGFR2, FGFR3, FGFR4, FLCN, FLT1, FLT3, FLT4, FOXL2, FUBP, GATA2, GEN1, GNA11, GNAQ, GNAS, H3F3A, HDAC9, HGF, HLA-A, HLA-B, HLA-C, HLA-DRB1HNF1A, HRAS, IDH1, IDH2, IGF1R, IGF2, JAK1, JAK2, JAK3, KDR, KIT, KMT2A, KRAS, LRP1B, LTK, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MAP3K4, MAPK1, MAPK3, MAPK8, MCL1, MDM2, MDM4, MED12, MEN1, MET, MITF, MLH1, MPL, MRE11, MSH2, MSH6, MTAP, MTOR, MYC, MYCN, NBN NF1, NF2, NFKBIA, NKX2-1, NOTCH1, NOTCH2, NOTCH2NL, NOTCH3, NOTCH4, NRAS, NTRK1*, NTRK2, NTRK3, NUTM1, PALB2 PARP1, PBRM1, PDGFB, PDGFRA, PDGFRB, PIK3CA, PIK3CB, PIK3CD, PIK3R1, PIK3R2, PMS2, POLE, PPARG, PTCH1, PTCH2, PTEN, PTPN11, RAD50, RAD51, RAD51C, RAD51D, RAF1, RARA, RB1, RET*, RICTOR, RNF43, ROS1*, RSPO1, RSPO2, RUNX1, SDHA, SDHB, SDHC, SDHD, SETD2, SLX4, SMAD2, SMAD4, SMARCA4, SMARCB1, SMO, SOX2, SOX9, SPOP SRC, STK11, SYK, TERTpromoTtEeTr2, TMPRSS2, TOP1, TOP2A, TP53, TSC1, TSC2, UBE2T, VHL, WT1, XPO1, XRCC2, ZNRF3.
*Include partial intron
TP53 OncoKitDX
CE IVD kit that has been designed to identify point mutations and small insertions and deletions withing coding regions, the promoter (5’UTR) and the non-coding part of exon 1 and 2, as well as splice site mutation on the TP53 gene. This kit is optimized to detect germline and somatic mutations in genomic DNA extracted from peripheral blood or tissue biopsies, by conventional multiplex PCR and Next generation sequencing (NGS).
- Format: 48 test
- Compatible with: Illumina
- Coverage: 99,4% of the bases covered with minimum sequencing depth 500X and 98,5% at 1000X
- Uniform coverage: 100% of amplicons are covered over 20% of the mean coverage
- Sensitivity and specificity: 99,9%
Genetics
HLAaccuTest All
The kit, available IVD and RUO, is a medical device for HLA (human leukocyte antigen) typing that can identify high resolution histocompatibility antigens using next generation sequencing (NGS). HLAaccuTest All for HLA typing using DNA extracted from whole blood can be applicable on organ transplant including hematopoietic stem cell transplant.
- Format: 24 or 96 test
- Compatible with: Illumina/MiSeq, MiSeq Dx
- Analysis software included: EasyHLAanalyzer
- Clinical validity: 99,7%
- Accuracy: 100%
Target HLA Locus:
Class I: A, B, C
Class II: DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, DPA1, DPB1