Diagnostic Products (Global)
Since 2008 we have been providing state-of-the-art in vitro diagnostic techniques such as molecular diagnostics to the medical, healthcare, and allied communities. During this time, we have continued to evolve on pace with global developments in the field, including developing new tests where there is a need for scale at low price points. Our vision is to continue building and deploying affordable and innovative diagnostic solutions for infectious diseases, cancers and genetic disorders, so as to provide the best possible outcome as well as experience for millions of citizens globally.
For more information about our kits, please email us at kit.sales@genepathdx.com
Infectious Diseases
GenePath Dx CoViDx One v2.1.1 (ICMR approved)
• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers: Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II
• Amenable to high throughput operations
• Single tube multiplexed RT-qPCR kit using four independent targets on the Covid-19 genome (SARS-CoV-2 specific RdRP x 2 loci, N gene x 1 locus and E gene x 1 locus) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation
GenePath Dx CoViQuick v2.0 - Extraction-less (ICMR approved+CE-IVD marked)
• 100% sensitivity and specificity as per the ICMR report
• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast processing including sample preparation and thermocycling
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP x 2, N gene x 1 and E gene x 1) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation
GenePath Dx CoViDx One v2.1.1TK-Quantitative (RUO)
• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers: Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II
• Amenable to high throughput operations
• Single tube multiplexed RT-qPCR kit using four independent targets on the Covid-19 genome (SARS-CoV-2 specific RdRP x 2 loci, N gene x 1 locus and E gene x 1 locus) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation
• Standards provided with the kit can be used for the quantification of SARS-CoV-2
• Secure online tool to assist with viral load calculation and data analysis
GenePath Dx CoviFlu v2.1 (RUO)
• Highly sensitive and specific single-tube assay for efficient use of real-time thermocyclers and increased laboratory throughput.
• Compatible with most 4-color detection cyclers: Green (495-520), Yellow (535-560), Orange (590-610) and Red (645-670).
• Multiple targets (SARS-CoV-2, Influenza A and Influenza B) increase confidence in diagnosis
• Presence of an endogenous human control gene allows process control through sample preparation.
GenePath Dx CoViDelta vME-2 RT-qPCR test kit (ICMR approved)
• Rapid identification of presumptive Omicron (B.1.1.529) Variant of Concern (VoC) based on absence of the S-gene Delta L452R mutation
• Flags both BA.1 and BA.2 sub-lineages of the Omicron VoC, aligning with the WHO guidelines of S-gene Target Failure (SGTF)
• Single tube, multiplexed assay with three confirmatory gene targets (RdRP-gene x 2 loci and N-gene x 1 locus) for SARS-CoV-2 diagnosis
• Presence of a human endogenous control allows process control through sample preparation
• Aids in prioritizing SARS-CoV-2 positive specimens with SGTF, for genomic sequencing to confirm the Omicron VoC
GenePath Dx CoviSpeedy RT-qPCR test kit - Extraction-less (RUO)
• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast thermocycling: 38 minutes on Bio-Rad CFX96 Touch (run time may vary from machine to machine)
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP-gene x 2, N-gene x 1 and E-gene x 1) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of a human endogenous control allows process control through sample preparation
GenePath Dx CoViFast v2.0 RT-qPCR Kit - Extraction-less
• 100% sensitivity and specificity
• Includes the proprietary ‘CoviPrep’ rapid (3 minutes) single-step (no heating) sample preparation reagent
• Fast thermocycling: 35 minutes on Bio-Rad CFX96 Touch (run time may vary from machine to machine)
• Single tube multiplexed RT-qPCR using four independent SARS-CoV-2 specific targets (RdRP – 2 targets, N-gene – 1 target, and E-gene - 1 target) to increase confidence in diagnosis and tolerance to presence of mutations at primer binding sites
• Presence of an endogenous human control gene allows process control through sample preparation
GenePath Dx Cytomegalovirus (CMV) qPCR test kit
• Highly sensitive and specific assay for the real time detection and quantification of Cytomegalovirus (CMV) with built-in internal control
• Four CMV target genes multiplexed into a single channel
• Short run time of less than 60 minutes
• Two channel assay with broad instrument compatibility (kit validated on the Bio-Rad CFX96, Bio-Rad Opus, QIAGEN Rotor-Gene Q, ABI QuantStudio 5, ABI 7500 and Roche Light Cycler 480 II; fluorophores compatible with most real time thermocyclers)
• Secure online tool to assist with viral load calculation and data analysis
GenePath Dx Wastewater Monitoring Assay (RUO)
• Screening test for monitoring and assessing the prevalence of SARS-CoV-2 in waste water
• Targeted S-gene kit, with a positive selection of Delta (L452R) and Omicron (E484A) markers along with SARS-CoV-2
confirmatory targets (RdRP-gene & N-gene)
• Highly sensitive and specific
• Compatible with a wide variety of thermocyclers
• Amenable to high throughput operations
• Presence of a waste water/ sewage/ fecal contamination marker along with a spiked process control in the kit, allows process control through sample preparation
• Uses the ‘UNG/dUTP’ system to minimize the risk of PCR carry-over contamination
Oncology
GenePath Dx BCR-ABL IS RQ-PCR test kit
• Minimal Residual Disease determination through BCR-ABL/ABL ratio reported on the International Scale (IS)
• Single-pot duplex assay with integrated reverse transcription (RT) / cDNA synthesis and qPCR
• Wide dynamic range / high sensitivity providing accurate quantification of the Major BCR-ABL e13/e14-a2 (p210) and ABL transcripts
• Reactions incorporate the dUTP / UNG system which helps to minimise carry-over contamination
• Two channel assay with broad instrument compatibility (kit validated on the Qiagen Rotor-Gene Q, Bio-Rad CFX96, Bio-Rad Opus, Roche LightCycler II 480, Thermo/ABI QuantStudio5 and StepOne instruments; fluorophores compatible with most real time thermocyclers)
• Secure online tool to assist with data analysis
GenePath Dx PML-RARA RQ-PCR test kit (RUO)
• Monitoring of Acute Promyelocytic Leukemia (APML) Minimal Residual Disease (MRD) through relative quantification of the PML-RARA fusion transcript
• Detects the common breakpoints of PML-RARA: (bcr2, V) (ex6a-ex3), (bcr1, L) (ex6b-ex3) and (bcr3, S) (ex3-ex3)
• Single-pot duplex assay with integrated reverse transcription (RT) / cDNA synthesis and qPCR
• Wide dynamic range / high sensitivity providing accurate quantification of the PML-RARA and ABL transcripts
• Reactions incorporate the dUTP / UNG system which helps to minimise carry-over contamination
• Two channel assay with broad instrument compatibility (kit validated on the Qiagen Rotor-Gene Q, Bio-Rad CFX96, Bio-Rad Opus, Roche LightCycler II 480, Thermo/ABI QuantStudio5 and StepOne instruments; fluorophores compatible with most real time thermocyclers)
• Secure online tool to assist with data analysis