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)
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.
Development status: Alpha-launch. Ongoing pipeline optimisation with estabilished shard-dx™ platforms. Proof-of-concept wet lab work undertaken.
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: 24 per target
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1-4
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
Alpha launch program: Join the shard-dx™ alpha 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.

Product name: LyoMorph-Q BRAF mutation kit
Product code (SKU): SD_ONC/M_00017
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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)

Product name: LyoMorph-Q JAK2 mutation kit
Product code (SKU): SD_ONC/M_00012
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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)

Product name: LyoMorph-Q KIT mutation kit
Product code (SKU): SD_ONC/M_00013
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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% all targets
Limit of Detection - copies (95%): 3 copies all targets
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)

Product name: LyoMorph-Q RET mutation kit
Product code (SKU): SD_ONC/M_00019
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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%
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)

Product name: LyoMorph-Q DPYD direct-SNP kit
Product code (SKU): SD_ONC/S_00001
Format: qPCR - lyophilized and inhibitor-tolerant (standard)
Potential use cases / info: The shard-dx™ DPYD kit may allow 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. Alternatively, swabs or saliva can be used extraction-free with shard-dx™ recommended tubes that are provided with the kit as an option. The kit can also be utilised with extracted gDNA from blood, swab or saliva. 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), saliva (direct), swab (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.

Product name: LyoMorph-Q IDH2 mutation kit
Product code (SKU): SD_ONC/M_00010
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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 - all six IDH2 mutations in one reaction):
- IDH2 [c.419G>A - R140Q] (FAM)
- IDH2 [c.515G>T - R172M] (FAM)
- IDH2 [c.515G>A - R172K] (FAM)
- IDH2 [c.516G>T - R172S] (FAM)
- IDH2 [c.514A>T - R172W] (FAM)
- IDH2 [c.514A>G - R172G] (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: 1
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.

Product name: LyoMorph-Q KRAS mutation kit 1
Product code (SKU): SD_ONC/M_00015
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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. KRAS mutation kit 1 may be combined with KRAS mutation kits 2 and 3 via multiplexing by shard-dx™. Assays also available as singleplex.
Targets (Reaction 1 - all mutations in one reaction):
- KRAS [c.34G>C - G12R] (FAM)
- KRAS [c.34G>A - G12S] (FAM)
- KRAS [c.34G>T - G12C] (FAM)
- KRAS [c.35G>C - G12A] (FAM)
- KRAS [c.35G>T - G12V] (FAM)
- KRAS [c.35G>A - G12D] (FAM)
- KRAS [c.38G>A - G13D] (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: 1
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.

Product name: LyoMorph-Q MPN panel kit
Product code (SKU): SD_ONC/M_00014
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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 complete, verficiation in progress.
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%): ≤0.1% 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: 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.

Product name: LyoMorph-Q PIK3CA pathway mutation kit 1
Product code (SKU): SD_ONC/M_00006
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q EGFR mutation kit 1
Product code (SKU): SD_ONC/M_00001
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q EGFR mutation kit 2
Product code (SKU): SD_ONC/M_00002
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q FGFR3 mutation kit
Product code (SKU): SD_ONC/M_00011
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q IDH1 mutation kit
Product code (SKU): SD_ONC/M_00009
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q KRAS mutation kit 2
Product code (SKU): SD_ONC/M_00003
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q KRAS mutation kit 3
Product code (SKU): SD_ONC/M_00004
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q NRAS mutation kit 1
Product code (SKU): SD_ONC/M_00007
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q NRAS mutation kit 2
Product code (SKU): SD_ONC/M_00008
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q TERT mutation kit
Product code (SKU): SD_ONC/M_00020
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

Product name: LyoMorph-Q PTEN mutation kit
Product code (SKU): SD_ONC/M_00005
Format: qPCR - lyophilized and inhibitor-tolerant (high specificity)
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.

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)
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.