Oncology products

Delivering complete PCR solutions for Oncology

SHARD DIAGNOSTICS™ Oncology qPCR assays deliver high-performance solutions across a range of applications.

Mutation detection assays are optimized for FFPE tissue and liquid biopsy (cfDNA), achieving analytical sensitivity down to 0.001% Variant Allele Frequency (VAF) with 95% calls for confident identification of low-frequency variants by qPCR, positioning the technology as an accessible method for longitudinal sample testing, minimal residual disease detection and cancer screening.

SHARD DIAGNOSTICS™ kit features

Each kit features inhibitor-tolerant reagents (lyo or liquid options) that deliver consistent amplification even from challenging or impure samples, effectively eliminating performance variability caused by the sample or extraction process. The universal chemistry supports all targets using a standardized cycling protocol, allowing multiple assays to run on the same 96-well plate. Quantified positive controls are included to standardise run performance across machines and provide quality control measures.

Solutions not just kits

Universal cycling & commonly used fluorophores utilised for fast integration.

Complete kits

Quantified controls included as standard for all targets including RNA and mutations.

Advanced performance

95% limit of detection for mutations down to 0.001% VAF and 3 copies by qPCR.

Available globally

Reagents are available in lyophilized formats for ambient shipping and are inhibitor-tolerant.

Custom Oncology specific kits

AVAILABLE (RUO): Semi-Personalised Cancer Panels for Minimal Residual Disease Monitoring

Product name: LyoMorph-X Semi-Personalised cancer kit_USER_NUMBER
Product code (SKU): SD_ONC/SPK_USER_NUMBER
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases/description: Detection of high frequency core cancer mutations by qPCR may play a role in cancer management through detection of minimal residual disease. A variant calling file and/or target file sent to shard-dx™ can be converted into a semi-personalised real-time PCR panel using our established panel of nearly 200 singleplex qPCR assays. Each ultrasensitive assay will be provided with quantified positive control material to ensure test standardisation and performance. Each assay is performed using the same reagent mix and cycling conditions for simplicity.
Targets:
Single Nucleotide Variant assays from our assay catalogue of nearly 200 established assays from the following commonly mutated genes: BRAF, EGFR, FGFR3, IDH1, IDH2, KIT, KRAS, NRAS, PIK3CA, PTEN, RET and TERT. Assays in other gene's are also in development or can be developed as custom kits from low-scale.
Assay Limit of Detection: 0.001%-0.1% VAF per target.
Detection method: Probe
Sample type: cfDNA, gDNA.
Reactions: 12-24 per target
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1-5
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): Personalised Cancer Panels for Minimal Residual Disease Monitoring

Product name: LyoMorph-X Personalised cancer kit_USER_NUMBER
Product code (SKU): SD_ONC/PK_USER_NUMBER
Format: qPCR/1-step RT-qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the variant(s) and other biomarkers by qPCR and/or RT-qPCR may play a role in cancer management through detection of minimal residual disease. A variant calling file and/or target file sent to shard-dx™ can be converted into a personalised real-time PCR panel by utilising established pipelines with our platforms. Each assay will be provided with quantified positive control material to ensure test standardisation and performance.
Targets:
Multi-analyte qPCR/RT-qPCR panels for early detection of minimal residual disease, treatment resistance and treatment assignment.
Includes: SNV's (cfDNA or combined with cfRNA), INDEL's, duplications, inversions, translocations, fusions and mRNA expression.
Detection method: Probe
Sample type: cfDNA/cfRNA, gDNA/gRNA and modifications thereof.
Reactions: 12-24 per target
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1-5
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

Oncology Kits (qPCR)

AVAILABLE (RUO): BRAF (codon 600/601) mutation kit

Product name: LyoMorph-Q BRAF mutation kit
Product code (SKU): SD_ONC/M_00023
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Targets (Reaction 1):
- BRAF [c.1799T>A - V600E] (FAM)
- RNase P [internal control] (HEX)
Targets (Reaction 2):
- BRAF [c.1799_1800TG>AA - V600E] (FAM)
- BRAF [c.1801A>G - K601E] (FAM)
- BRAF [c.1799_1800TG>AT - V600D] (FAM)
- BRAF [c.1798_1799GT>AA - V600K] (FAM)
- BRAF [c.1798_1799GT>AG - V600R] (FAM)
- RNase P [internal control] (HEX)
Limit of Detection - variant allele frequency (95%): 0.0036% - 0.015% VAF
Limit of Detection - copies (95%): 3 to 5 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 2
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): ESR1 (codon 380/463/535-538) mutation kit

Product name: LyoMorph-Q ESR1 mutation kit
Product code (SKU): SD_ONC/M_00021
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Targets (Reaction 1):
- ESR1 [c.1607T>A - L536H] (FAM) < LOD 0.01% >
- ESR1 [c.1604C>A - P535H] (FAM) < LOD 0.01% >
- ESR1 [c.1607_1608delinsAG (TC>AG) - L536Q] (FAM) < LOD 0.01% >
- ESR1 [c.1609T>G - Y537D] (FAM) < LOD 0.01% >
- ESR1 [c.1601T>A - V534E] (FAM) < LOD 0.01% >
- ESR1 [c.1138G>C - E380Q] (HEX) < LOD 0.01% >
- RNase P [internal control] (ATTO647N)
Targets (Reaction 2):
- ESR1 [c.1610A>C - Y537S] (FAM) < LOD 0.016% >
- ESR1 [c.1609T>A - Y537N] (FAM) < LOD 0.016% >
- ESR1 [c.1613A>G - D538G] (FAM) < LOD 0.016% >
- ESR1 [c.1607T>G - L536R] (FAM) < LOD 0.016% >
- ESR1 [c.1610A>G - Y537C] (FAM) < LOD 0.016% >
Targets (Reaction 3):
- ESR1 [c.1265_1267del - V422del] (FAM) < LOD 0.01% >
- ESR1 [c.1388C>G - S463C] (HEX) < LOD 0.01% >
- ESR1 [c.1387T>C - S463P] (HEX) < LOD 0.06% >
Targets (Reaction 4):
- ESR1 [c.1607T>C - L536P] (FAM) < LOD 0.016% >
- RNase P [internal control] (HEX)
Limit of Detection - variant allele frequency (95%): 0.01% (3 copies) - 0.06% (20 copies) VAF
Limit of Detection - copies (95%): 3-20 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
qPCR Cycling time: 1 hour 15 minutes
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): JAK2 (codon 617) mutation kit

Product name: LyoMorph-Q JAK2 mutation kit
Product code (SKU): SD_ONC/M_00012
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Targets (Reaction 1):
- JAK2 [c.1849G>T - V617F] (FAM)
- RNase P [internal control] (HEX)
Limit of Detection - variant allele frequency (95%): 0.001% VAF
Limit of Detection - copies (95%): 3 mutant copies
Detection method: Probe
Sample type: gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): KIT (codon 816) mutation kit

Product name: LyoMorph-Q KIT mutation kit
Product code (SKU): SD_ONC/M_00013
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Targets (Reaction 1 - all KIT mutations in one reaction):
- KIT [c.2446G>T - D816Y] (FAM)
- KIT [c.2446G>C - D816H] (FAM)
- KIT [c.2447A>T - D816V] (FAM)
- RNase P [internal control] (HEX)
Limit of Detection - variant allele frequency (95%): 0.01% VAF
Limit of Detection - copies (95%): 3 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): MPN panel kit (BCR-ABL, JAK2, CALR, MPL)

Product name: LyoMorph-Q MPN panel kit
Product code (SKU): SD_ONC/M_00014
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Targets (Reaction 1):
- BCR-ABL [E13A2] (FAM)
- BCR-ABL [E14A2] (HEX)
- BCR-ABL [E1A2] (ATTO647N)
- ABL [A1A2 Reference] (ATTO590)
Targets (Reaction 2):
- JAK2 [c.1849G>T - V617F] (FAM)
- MPL [c.1544G>T - W515L] (HEX)
- MPL [c.1543-44TG>AA - W515K] (HEX)
- MPL [c.1543-44TG>GC - W515A] (HEX)
- RNase P [internal control] (ATTO647N)
Targets (Reaction 3):
- CALR [c.1092_1143del - L367fs*46] (FAM)
- CALR [c.1154_1155insTTGTC - K385fs*47] (FAM)
- MPL [c.1514G>A - S505N] (HEX)
Limit of Detection - variant allele frequency (95%): 0.001-0.1% VAF
Limit of Detection - copies (95%): 3-10 mutant copies
Detection method: Probe
Sample type: gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

AVAILABLE (RUO): RET (codon 918) mutation kit

Product name: LyoMorph-Q RET mutation kit
Product code (SKU): SD_ONC/M_00019
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Targets (reaction 1):
- RET [c.2753T>C - M918T] (FAM)
- RNase P [internal control] (HEX)
Limit of Detection - variant allele frequency (95%): 0.01% VAF
Limit of Detection - copies (95%): 3 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.

BETA LAUNCH: EGFR (codon 768/790/797/858/861 and exon 19/20 indel) mutation kit

Product name: LyoMorph-Q EGFR mutation kit
Product code (SKU): SD_ONC/M_00001
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimised and verification in progress.
Targets:
Targets (Reaction 1):
- EGFR [c.2390G>C - C797S] (HEX)
- EGFR [c.2389T>C - C797R] (HEX)
- EGFR [c.2389T>A - C797S] (HEX)
- EGFR [c.2307_2308insGCCAGCGTG] (FAM)
- EGFR [c.2319_2320insCAC] (FAM)
- EGFR [c.2310_2311insGGT] (FAM)
- EGFR [c.2319-2320insCCCCAC] (FAM)
- EGFR [c.2319-2320ins-CCCACG] (FAM)
- EGFR [c.2319-2320insAAACCCCAC] (FAM)
- EGFR [c.2156 G>C - G719A] (ATTO647N)
- EGFR [c.2155 G>A - G719S] (ATTO647N)
- EGFR [c.2155 G>T - G719C] (ATTO647N)
Targets (Reaction 2):
- EGFR [c.2573T>G - L858R] (FAM)
- EGFR [c.2582T>A - L861Q] (FAM)
- EGFR [c.2303G>T - S768I] (ATTO590)
- EGFR [c.2236_2250del] (ATTO647N)
- EGFR [c.2236_2253del] (ATTO647N)
- EGFR [c.2237_2251del] (ATTO647N)
- EGFR [c.2235_2252delinsAAT] (ATTO647N)
- EGFR [c.2237_2254del] (ATTO647N)
- EGFR [c.2238_2255del] (ATTO647N)
- EGFR [c.2237_2255delinsT] (ATTO647N)
- EGFR [c.2237_2257delinsTCT] (ATTO647N)
- EGFR [c.2239_2247del] (ATTO647N)
- EGFR [c.2240_2248del] (ATTO647N)
- EGFR [c.2239_2248delinsC] (ATTO647N)
- EGFR [c.2238_2248delinsGC] (ATTO647N)
- EGFR [c.2240_2254del] (ATTO647N)
- EGFR [c.2239_2251delinsC] (ATTO647N)
- EGFR [c.2238_2252delinsGCA] (ATTO647N)
- EGFR [c.2240_2251del] (ATTO647N)
- EGFR [c.2239_2256del] (ATTO647N)
- EGFR [c.2240_2257del] (ATTO647N)
- EGFR [c.2239_2258delinsCA] (ATTO647N)
- EGFR [c.2235_2249del15] (ATTO647N)
- EGFR [c.2237_2253>TTGCT] (ATTO647N)
- EGFR [c.2238_2252del] (ATTO647N)
- EGFR [c.2239_2257>GT] (ATTO647N)
- RNase P [internal control] (HEX)
Targets (Reaction 3):
- EGFR [c.2369C>T - T790M] (HEX)
Limit of Detection - variant allele frequency (95%): 0.01-0.1% VAF
Limit of Detection - copies (95%): 3-10 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

BETA LAUNCH: IDH1 (codon 100/132) mutation kit

Product name: LyoMorph-Q IDH1 mutation kit
Product code (SKU): SD_ONC/M_00009
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimised and verification in progress.
Targets:
- IDH1 [c.299G>A - R100Q]
- IDH1 [c.394_395delinsGT - R132V]
- IDH1 [c.395G>A - R132H]
- IDH1 [c.394C>T - R132C]
- IDH1 [c.394C>G - R132G]
- IDH1 [c.394C>A - R132S]
- IDH1 [c.395G>T - R132L]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 2
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

BETA LAUNCH: IDH2 (codon 140/172) mutation kit

Product name: LyoMorph-Q IDH2 mutation kit
Product code (SKU): SD_ONC/M_00010
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimised and verification in progress.
Targets:
- IDH2 [c.419G>A - R140Q]
- IDH2 [c.515G>T - R172M]
- IDH2 [c.515G>A - R172K]
- IDH2 [c.516G>T - R172S]
- IDH2 [c.514A>T - R172W]
- IDH2 [c.514A>G - R172G]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 2
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

BETA LAUNCH: KRAS (codon 12/13/59/61/117/146) mutation kit

Product name: LyoMorph-Q KRAS mutation kit
Product code (SKU): SD_ONC/M_00015
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimised and verification in progress.
Targets:
- KRAS [c.34G>C - G12R]
- KRAS [c.34G>T - G12C] (separately identified)
- KRAS [c.34G>A - G12S]
- KRAS [c.35G>C - G12A]
- KRAS [c.35G>A - G12D]
- KRAS [c.35G>T - G12V]
- KRAS [c.36_37delinsGC - G13R]
- KRAS [c.37G>T - G13C]
- KRAS [c.37G>A - G13S]
- KRAS [c.38G>C - G13A]
- KRAS [c.38G>T - G13V]
- KRAS [c.38G>A - G13D]
- KRAS [c.175G>T - A59S]
- KRAS [c.175G>A - A59T]
- KRAS [c.176C>A - A59E]
- KRAS [c.176C>G - A59G]
- KRAS [c.181C>G - Q61E]
- KRAS [c.181C>A - Q61K]
- KRAS [c.182A>T - Q61L]
- KRAS [c.182A>C - Q61P]
- KRAS [c.182A>G - Q61R]
- KRAS [c.183A>T - Q61H]
- KRAS [c.183A>C - Q61H]
- KRAS [c.351A>C - K117N]
- KRAS [c.351A>T - K117N]
- KRAS [c.436G>C - A146P]
- KRAS [c.437C>T - A146V]
- KRAS [c.436G>A - A146T]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): 0.1% VAF planned
Limit of Detection - copies (95%): 3-10 mutant copies planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

BETA LAUNCH: NRAS (codon 12/13/59/61/117/146) mutation kit

Product name: LyoMorph-Q NRAS mutation kit
Product code (SKU): SD_ONC/M_00007
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimisation in progress.
Targets (fluorophores to be finalised):
- NRAS [c.34G>T - G12C]
- NRAS [c.35G>A - G12D]
- NRAS [c.35G>C - G12A]
- NRAS [c.34G>C - G12R]
- NRAS [c.38G>C - G13A]
- NRAS [c.37G>C - G13R]
- NRAS [c.37G>T - G13C]
- NRAS [c.37G>A - G13S]
- NRAS [c.35G>T - G12V]
- NRAS [c.34G>A - G12S]
- NRAS [c.38G>T - G13V]
- NRAS [c.175G>A - A59T]
- NRAS [c.176C>A - A59D]
- NRAS [c.182A>G - Q61R]
- NRAS [c.183A>C - Q61H]
- NRAS [c.183A>T - Q61H]
- NRAS [c.182A>T - Q61L]
- NRAS [c.182A>C - Q61P]
- NRAS [c.181C>G - Q61E]
- NRAS [c.181C>A - Q61K]
- NRAS [c.351G>C - K117N]
- NRAS [c.351G>T - K117N]
- NRAS [c.436G>A - A146T]
- NRAS [c.437C>T - A146V]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

BETA LAUNCH: PIK3CA (codon 420/542/545/546/1047) & AKT1 (E17K) mutation kit

Product name: LyoMorph-Q PIK3CA/AKT1 mutation kit
Product code (SKU): SD_ONC/M_00006
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Beta launch. Multiplex optimised and verification in progress.
Targets (Reaction 1):
- PIK3CA [c.1624G>A - E542K] (FAM)
- PIK3CA [c.1635G>T - E545D] (FAM)
- PIK3CA [c.1258T>C - C420R] (ATTO647N)
Targets (Reaction 2):
- PIK3CA [c.1633G>A - E545K] (FAM)
- PIK3CA [c.1636C>G - Q546E] (FAM)
- PIK3CA [c.3140A>T - H1047L] (HEX)
- PIK3CA [c.3140A>G - H1047R] (HEX)
- RNase P [internal control] (ATTO647N)
Targets (Reaction 3):
- AKT1 [c.49 G>A - E17K] (ATTO647N)
Limit of Detection - variant allele frequency (95%): 0.01-0.1% VAF
Limit of Detection - copies (95%): 3-20 mutant copies
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Beta launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

ALPHA LAUNCH: FGFR3 (codon 248/249/370/373/652) mutation kit

Product name: LyoMorph-Q FGFR3 mutation kit
Product code (SKU): SD_ONC/M_00011
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) in FFPE tumour DNA or liquid biopsy may play a role in cancer screening, monitoring and/or profiling.
Development status: Alpha launch. Singleplex tested & multiplex optimisation in progress.
Targets (fluorophores to be finalised):
- FGFR3 [c.746C>G - S249C]
- FGFR3 [c.742C>T - R248C]
- FGFR3 [c.1118A>G - Y373C]
- FGFR3 [c.1108G>T - G370C]
- FGFR3 [c.1954A>G - K652E]
- FGFR3 [c.1954A>C - K652Q]
- FGFR3 [c.1955A>T - K652M]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Alpha launch program: Join the shard-dx™ alpha access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

ALPHA LAUNCH: TERT (C228T, C250T) mutation kit

Product name: LyoMorph-Q TERT mutation kit
Product code (SKU): SD_ONC/M_00020
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Development status: Alpha launch. Singleplex tested & multiplex optimisation in progress.
Targets (fluorophores to be finalised):
- TERT [c.-146C>T - C250T]
- TERT [c.-124C>T - C228T]
- RNase P [internal control]
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Alpha launch program: Join the shard-dx™ alpha access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

ALPHA LAUNCH: PTEN (codon 124/129/130/173/233) mutation kit

Product name: LyoMorph-Q PTEN mutation kit
Product code (SKU): SD_ONC/M_00005
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) may play a role in cancer screening, monitoring and/or profiling.
Development status: Alpha launch. Singleplex tested & multiplex optimisation in progress. PTEN mutation kit may be combined with PIK3CA pathway mutation kit 1 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- PTEN [c.370T>C - C124S]
- PTEN [c.371G>A - C124Y]
- PTEN [c.386G>A - G129E]
- PTEN [c.385G>C - G129R]
- PTEN [c.389G>A - R130Q]
- PTEN [c.388C>G - R130G]
- PTEN [c.388C>T - R130X]
- PTEN [c.517C>T - R173C]
- PTEN [c.518G>A - R173H]
- PTEN [c.697C>T - R233X]
- RNase P [internal control]
- plus additional indels to be determined.
Limit of Detection - variant allele frequency (95%): ≤0.1% planned
Limit of Detection - copies (95%): ≤10 planned
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 96
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Alpha launch program: Join the shard-dx™ alpha access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

PRE-LAUNCH: Multi-analyte cancer screening kit

Product name: LyoMorph-X cancer screening kit X
Product code (SKU): SD_ONC/CS_XXXXX
Format: qPCR/1-step RT-qPCR - lyophilized and inhibitor-tolerant (high specificity). Also provided in liquid format.
Potential use cases: Detection of the mutation(s) and other biomarkers by qPCR and/or RT-qPCR may play a role in cancer screening, monitoring and/or profiling.
Development status: Pre-launch. Ongoing research and development, including in-silico analysis with estabilished shard-dx™ platforms.
Targets:
Multi-analyte qPCR/RT-qPCR panels for early detection of undiagnosed cancers.
Exact cancers and targets will be released at launch.
Detection method: Probe
Sample type: FFPE gDNA/gRNA, cfDNA/cfRNA, gDNA/gRNA
Reactions: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO), not for use in diagnostic procedures.
Pre-launch program: Join the shard-dx™ pre-launch access program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

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Launch Program Definitions

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PRE-LAUNCH >

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Development status: Product initiated for development via established shard-dx™ technology.
Pre-launch program: Join the shard-dx™ pre-launch access program to generate cutting-edge kits alongside us. The program provides customers early access to upcoming kits, opportunities for free of charge customisation and a 12-month 20% discount on the kit upon official ‘AVAILABLE (RUO)’ launch [max 25 x 96 reaction kits]. Additionally, a 15% discount will be available for pre-launch access customers on all shard-dx™ products [discounts cannot be combined, max 10 orders]. Find out more about the pre-launch program by emailing info@shard-dx.com. Pre-launch program access terms and conditions apply.

ALPHA LAUNCH >

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Development status: Product initiated for development via established shard-dx™ technology. In-silico and proof-of-concept wet-lab development undertaken.
Alpha launch program: Join the shard-dx™ alpha access program to generate cutting-edge kits alongside us. The program provides customers early access to upcoming kits, opportunities for free of charge customisation and a 12-month 20% discount on the kit upon official ‘AVAILABLE (RUO)’ launch [max 15 x 96 reaction kits]. Additionally, a 15% discount will be available for alpha access customers on all shard-dx™ products [discounts cannot be combined, max 7 orders]. Find out more about the alpha program by emailing info@shard-dx.com. Alpha program access terms and conditions apply.

BETA LAUNCH >

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Development status: Near finished product via established shard-dx™ technology. Wet-lab development with significant optimisation undertaken.
BETA launch program: Join the shard-dx™ beta access program to generate cutting-edge kits alongside us. The program provides customers early access to kits launching soon, opportunities for free of charge customisation and a 12-month 20% discount on the kit upon official ‘AVAILABLE (RUO)’ launch [max 10 x 96 reaction kits]. Additionally, a 10% discount will be available for beta access customers on all shard-dx™ products [discounts cannot be combined, max 5 orders]. Find out more about the beta program by emailing info@shard-dx.com. Beta program access terms and conditions apply.

AVAILABLE (RUO) >

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Development status: Product is an established Research Use Only (RUO) kit, not for use in diagnostic procedures.
SHARD DIAGNOSTICS™ Quality Management System (QMS) status: Internal QMS operational. Preparation phase for ISO9001 & ISO13485.
Additional options: Kit can be customised at a reduced cost to the customer compared with a stand alone custom kit. Additional sample, workflow and automation validation for the kit may be available at a reduced cost to the customer compared with stand alone custom kits.

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UK. Registered No 15798577SHARD DIAGNOSTICS™ and shard-dx™ are trademarks of SHARD DIAGNOSTICS LTD. All rights reserved.

UK. Registered No 15798577

SHARD DIAGNOSTICS™ and shard-dx™ are trademarks of SHARD DIAGNOSTICS LTD. All rights reserved.