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Oncology products

Delivering complete PCR solutions for Oncology

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

SNP Detection assays are performed direct-on-sample from matrices such as undiluted blood or saliva, eliminating the need for extraction and reducing sample mixups by requiring only one pipetting step.

SHARD DIAGNOSTICS™ kit features

Each kit features lyophilized inhibitor-tolerant reagents 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

All reagents are lyophilized for ambient shipping and are inhibitor-tolerant.

Launch Program Definitions

The shard-dx™ product launch pathway allows customers to access the technology earlier with exciting rewards.

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Custom Oncology kits

AVAILABLE (RUO): Custom qPCR kits

Find out more about custom PCR kits on our dedicated pages.
Format: Lyophilized inhibitor-tolerant qPCR or 1-step RT-qPCR.
Applications: Variant detection (DNA and/or RNA), gene expression, target quantification, target qualitative detection, extraction-free, rapid detection and cartridge-based system integration.
Targets: Singleplex or multiplex.
Detection method: Probe.
Shipping: Ambient.
Positive control inclusion: Yes.
Regulatory status: Research Use Only (RUO).
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

BETA LAUNCH (RUO): Custom dPCR kits

Find out more about custom PCR kits on our dedicated pages.
Format: Lyophilized inhibitor-tolerant dPCR or 1-step RT-dPCR.
Applications: Variant detection, gene expression and target quantification.
Targets: Singleplex or multiplex.
Detection method: Probe.
Shipping: Ambient.
Positive control inclusion: Yes.
Regulatory status: Research Use Only (RUO).
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Development status: Beta launch. Ongoing validation with established shard-dx™ platforms.
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.
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

PRE-LAUNCH (RUO): Custom amplicon sequencing kits

Find out more about custom PCR kits on our dedicated pages.
Format: Lyophilized inhibitor-tolerant PCR or 1-step RT-PCR.
Applications: Variant detection, gene expression, target qualitative detection and extraction-free.
Targets: Multiplex, long and short read.
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Shipping: Ambient.
Positive control inclusion: Yes.
Development status: Pre-launch. Ongoing research and development with established lyophilized inhibitor tolerant shard-dx™ platforms.
Regulatory status: Research Use Only (RUO).
Pre-launch program: Join the shard-dx™ pre-launch program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

Oncology Kits (qPCR)

AVAILABLE (RUO): BRAF (V600E) mutation kit

Product name: LyoMorph-Q BRAF mutation kit
Product code (SKU): SD_ONC/M_00017
Format: qPCR - lyophilized and inhibitor-tolerant
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)
Limit of Detection - variant allele frequency (95%): 0.001%
Limit of Detection - copies (95%): 3
Detection method: Probe
Sample type: FFPE gDNA, cfDNA, gDNA
Reactions: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)

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
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%
Limit of Detection - copies (95%): 3
Detection method: Probe
Sample type: gDNA
Reactions: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)

BETA LAUNCH: DPYD (direct: blood) SNP genotyping kit

Product name: LyoMorph-Q DPYD direct-SNP kit
Product code (SKU): SD_ONC/S_00001
Format: qPCR - lyophilized and inhibitor-tolerant
Potential use cases / info: The shard-dx™ DPYD kit allows for rapid detection of the four clinically recognised SNPs in under 1 hour. The assay does not require blood to be diluted to perform the test but does require the use of K2 EDTA tubes for collection. The kit can also be utilised with extracted gDNA from blood. Detection of DPYD SNPs may play a role in detecting potential toxicity to 5-FU chemotherapy for individuals.
Development status: Beta launch. Multiplex optimisation in finalisation.
Targets (Reaction 1 - allele 1):
- DPYD [c.1129-5923C>G] (FAM)
- DPYD [c.1679T>G] (HEX)
- DPYD [c.1905+1G>A] (ATTO 647)
- DPYD [c.2846A>T] (ATTO 590)
Targets (Reaction 2 - allele 2):
- DPYD [c.1129-5923 wild-type] (FAM)
- DPYD [c.1679 wild-type] (HEX)
- DPYD [c.1905+1 wild-type] (ATTO 647)
- DPYD [c.2846 wild-type] (ATTO 590)
Limit of Detection - copies (95%): ≤100 planned
Detection method: Probe
Sample type: gDNA, whole blood (direct)
Reactions: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 2
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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 420/542/545/1047) & AKT1 (E17K) mutation kit 1

Product name: LyoMorph-Q PIK3CA pathway mutation kit 1
Product code (SKU): SD_ONC/M_00006
Format: qPCR - lyophilized and inhibitor-tolerant
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 optimisation in finalisation.
Targets (Reaction 1):
- PIK3CA [c.1624G>A - E542K] (FAM)
- PIK3CA [c.1258T>C - C420R] (ATTO 647)
- RNase P [internal control] (HEX)
Targets (Reaction 2):
- PIK3CA [c.1635G>T - E545D] (FAM)
- PIK3CA [c.3140A>G - H1047R] (HEX)
- AKT1 [c.49 G>A - E17K] (ATTO 647)
Targets (Reaction 3):
- PIK3CA [c.1633G>A - E545K] (FAM)
- PIK3CA [c.3140A>T - H1047L] (HEX)
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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 3
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: EGFR (codon 719/768/790/797/858/861) mutation kit 1

Product name: LyoMorph-Q EGFR mutation kit 1
Product code (SKU): SD_ONC/M_00001
Format: qPCR - lyophilized and inhibitor-tolerant
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. EGFR mutation kit 1 may be combined with EGFR mutation kit 2 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- EGFR [c.2390G>C - C797S]
- EGFR [c.2389T>C - C797R]
- EGFR [c.2389T>A - C797S]
- EGFR [c.2573T>G - L858R]
- EGFR [c.2582T>A - L861Q]
- EGFR [c.2369C>T - T790M]
- EGFR [c.2303G>T - S768I]
- EGFR [c.2156G>C - G719A]
- EGFR [c.2155 G>A - G719S]
- EGFR [c.2155 G>T - G719C]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: EGFR (exon 19/20 indel) mutation kit 2

Product name: LyoMorph-Q EGFR mutation kit 2
Product code (SKU): SD_ONC/M_00002
Format: qPCR - lyophilized and inhibitor-tolerant
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. EGFR mutation kit 2 may be combined with EGFR mutation kit 1 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- EGFR [c.2236_2250del]
- EGFR [c.2236_2253del]
- EGFR [c.2237_2251del]
- EGFR [c.2235_2252delinsAAT]
- EGFR [c.2237_2254del]
- EGFR [c.2238_2255del]
- EGFR [c.2237_2255delinsT]
- EGFR [c.2237_2257delinsTCT]
- EGFR [c.2239_2247del]
- EGFR [c.2240_2248del]
- EGFR [c.2239_2248delinsC]
- EGFR [c.2238_2248delinsGC]
- EGFR [c.2240_2254del]
- EGFR [c.2239_2251delinsC]
- EGFR [c.2238_2252delinsGCA]
- EGFR [c.2240_2251del]
- EGFR [c.2239_2256del]
- EGFR [c.2240_2257del]
- EGFR [c.2239_2258delinsCA]
- EGFR [c.2235_2249del15]
- EGFR [c.2237_2253>TTGCT]
- EGFR [c.2238_2252del]
- EGFR [c.2239_2257>GT]
- EGFR [c.2307_2308insGCCAGCGTG]
- EGFR [c.2319_2320insCAC]
- EGFR [c.2310_2311insGGT]
- EGFR [c.2319-2320insCCCCAC]
- EGFR [c.2319-2320ins-CCCACG]
- EGFR [c.2319-2320insAAACCCCAC]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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):
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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):
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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):
- KIT [c.2446G>T - D816Y]
- KIT [c.2446G>C - D816H]
- KIT [c.2447A>T - D816V]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: KRAS (codon 12/13) mutation kit 1

Product name: LyoMorph-Q KRAS mutation kit 1
Product code (SKU): SD_ONC/M_00015
Format: qPCR - lyophilized and inhibitor-tolerant
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 finalisation. KRAS mutation kit 1 may be combined with KRAS mutation kits 2 and 3 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- KRAS [c.34G>C - G12R]
- KRAS [c.34G>A - G12S]
- KRAS [c.34G>T - G12C]
- KRAS [c.35G>C - G12A]
- KRAS [c.35G>T - G12V]
- KRAS [c.35G>A - G12D]
- KRAS [c.37G>T - G13C]
- KRAS [c.38G>A - G13D]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: KRAS (codon 61) mutation kit 2

Product name: LyoMorph-Q KRAS mutation kit 2
Product code (SKU): SD_ONC/M_00003
Format: qPCR - lyophilized and inhibitor-tolerant
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. KRAS mutation kit 2 may be combined with KRAS mutation kits 1 and 3 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- KRAS [c.183A>T - Q61H]
- KRAS [c.183A>C - Q61H]
- KRAS [c.182A>G - Q61R]
- KRAS [c.182A>T - Q61L]
- KRAS [c.181C>A - Q61K]
- KRAS [c.182A>C - Q61P]
- KRAS [c.181C>G - Q61E]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: KRAS (codon 146) mutation kit 3

Product name: LyoMorph-Q KRAS mutation kit 3
Product code (SKU): SD_ONC/M_00004
Format: qPCR - lyophilized and inhibitor-tolerant
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. KRAS mutation kit 3 may be combined with KRAS mutation kits 1 and 2 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- KRAS [c.436G>A - A146T]
- KRAS [c.437C>T - A146V]
- KRAS [c.436G>C - A146P]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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):
- BCR-ABL [fusions]
- JAK2 [c.1849G>T - V617F]
- CALR [c.1092_1143del - L367fs*46]
- CALR [c.1154_1155insTTGTC - K385fs*47]
- MPL [c.1544G>T - W515L]
- MPL [c.1543-44TG>AA - W515K]
- MPL [c.1543-44TG>GC - W515A]
- MPL [c.1514G>A - S505N]
- 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: gDNA
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)
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: NRAS (codon 12/13) mutation kit 1

Product name: LyoMorph-Q NRAS mutation kit 1
Product code (SKU): SD_ONC/M_00007
Format: qPCR - lyophilized and inhibitor-tolerant
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. NRAS mutation kit 1 may be combined with NRAS mutation kit 2 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- NRAS [c.35G>A - G12D]
- NRAS [c.35G>T - G12V]
- NRAS [c.34G>T - G12C]
- NRAS [c.37G>C - G13R]
- NRAS [c.38G>A - G13D]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: NRAS (codon 61) mutation kit 2

Product name: LyoMorph-Q NRAS mutation kit 2
Product code (SKU): SD_ONC/M_00008
Format: qPCR - lyophilized and inhibitor-tolerant
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. NRAS mutation kit 2 may be combined with NRAS mutation kit 1 via multiplexing by shard-dx™.
Targets (fluorophores to be finalised):
- NRAS [c.182A>G - Q61R]
- NRAS [c.181C>A - Q61K]
- NRAS [c.182A>T - Q61L]
- NRAS [c.183A>C - Q61H]
- NRAS [c.183A>T - Q61H]
- NRAS [c.182A>C - Q61P]
- NRAS [c.181C>G - Q61X]
- 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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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: 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
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:
- RET [c.2753T>C - M918T] (FAM)
- RNase P [internal control] (HEX)
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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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_00019
Format: qPCR - lyophilized and inhibitor-tolerant
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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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
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: 48
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: TBD
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
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
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)
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.

PRE-LAUNCH: Personalised cancer panels for minimal residual disease monitoring

Product name: LyoMorph-X cancer screening kit X
Product code (SKU): SD_ONC/PK_XXXXX
Format: qPCR/1-step RT-qPCR - lyophilized and inhibitor-tolerant
Potential use cases: Detection of the mutation(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.
Development status: Pre-launch. Ongoing research and development, including in-silico analysis with estabilished shard-dx™ platforms. Proof-of-concept wet lab work undertaken.
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: cfDNA/cfRNA, gDNA/gRNA and modifications thereof.
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)
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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