OEM kits and technology

Differentiate your product offering with best-in-class PCR technology

Your business with our technology. Whether you want to improve the performance of an existing test or bring a novel idea to life, SHARD DIAGNOSTICS™ is your solution to leveling up your PCR offering. We can support any size of project from a one-off kit to a complete line of kits.

Our experts will work closely with you to understand your requirements and build a comprehensive plan. White-label manufacturing is also available in a variety of customisable formats including branded packaging.

shard-dx™ Technology

SHARD DIAGNOSTICS™ specialises in combining expert reagent formulation with expert assay design to create high performance kits for qPCR, digital PCR, & amplicon sequencing.

Sensitive & multiplexed

Down to 0.001% VAF & 3 copy LOD by qPCR

High inhibitor tolerance

Extraction-free with blood, saliva, & more

Ambient shipping

Lyophilized reagents (PCR/1-step RT-PCR)

The shard-dx™ OEM process for custom kits

Step 1: Initial consultation
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Step 2: Custom design
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Step 3: Quality control
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Step 4: delivery and support
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Trusted expertise

Benefit from our strong manufacturing background and expertise in assay development

Full support

Our team will work closely with you at every stage to ensure we meet your complete design requirements

Superior performance

Take advantage of shard-dx™ technology to ensure your assays deliver best-in-class performance

Globally scalable

Take the fear out of large scale dry ice shipments by converting to our lyophilized PCR kits

Custom kits for OEM

AVAILABLE (RUO): Custom qPCR kits

Format: Inhibitor-tolerant qPCR or 1-step RT-qPCR (lyo or liquid).
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.

AVAILABLE (RUO): Custom dPCR assays

Format: dPCR or 1-step RT-dPCR assays for combination with machine specific reagents.
Applications: Digitial PCR (dPCR) provides precise, absolute quantification for a range of applications. Shard-dx™ assays are compatible with dPCR workflows, providing minimal to no rain with strong signal. Custom assay development is available from low minimum order quantity to meet specific requirements. Each assay includes a quantified positive control to support reliable setup and consistent performance. Applications include: variant detection, gene expression, high-order multiplexing 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).
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

ALPHA LAUNCH (RUO): Custom amplicon sequencing kit

Format: Lyophilized inhibitor-tolerant PCR or 1-step RT-PCR.
Applications: Custom amplicon sequencing panels enable high-multiplex PCR enrichment for downstream sequencing workflows. Powered by LyoMorph™ chemistry, they maintain sensitivity and uniform amplification across complex samples, supporting sequencing-ready amplicons from both extracted and extraction-free inputs.
LyoMorph™-N supports extraction workflows with multiplexed amplicons up to 2kb (1 to 50 amplicons of 50-200bp or 1 to 10 amplicons of up to 2000bp).
LyoMorph™-N+ enables long-range multiplex amplification up to 50kb from extracted material (1 to 100 amplicons of 100-2000bp or 1 to 5 amplicons of up to 50,000bp).
Targets: Multiplex, long and short read.
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Shipping: Ambient.
Positive control inclusion: Yes.
Development status: Alpha launch. Ongoing optimisation via established lyophilized inhibitor tolerant shard-dx™ platforms.
Regulatory status: Research Use Only (RUO).
Alpha launch program: Join the shard-dx™ alpha 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.

Book an OEM kit consultation

Launch program definitions

PRE-LAUNCH >
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ALPHA LAUNCH >
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BETA LAUNCH >
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AVAILABLE (RUO) >
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AVAILABLE (CE-IVD or FDA)
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Contact Us

Location:

BioCity Nottingham, Pennyfoot Street, Nottingham, England, NG1 1GF

Email:

info@shard-dx.com


UK. Registered No 15798577

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