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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.

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

shard-dx™ Technology

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

Down to 0.001% VAF & 3 copies

95% calls by qPCR, including mutations

Extraction-free PCR assays

Up to 25% undiluted blood, saliva & more

>30 days stability at 40°C

Lyophilized reagents only in shard-dx™ kits

Custom kits for OEM

AVAILABLE (RUO): Custom qPCR kits

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

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 kit

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.

Launch program definitions

PRE-LAUNCH >

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Development status: Service 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: Service 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 service 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: Service is established for the creation of research use only kits.
SHARD DIAGNOSTICS™ Quality Management System (QMS) status: Internal QMS operational. Preparation phase for ISO9001 & ISO13485. External manufacturing of complete kits under GMP and/or ISO13485 is available and can be organised by shard-dx™.
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.

AVAILABLE (CE-IVD or FDA)

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Development status: Service can produce a product that is an established CE-IVD or FDA-cleared kit.
SHARD DIAGNOSTICS™ Quality Management System (QMS) status: Internal QMS operational. Preparation phase for ISO9001 & ISO13485. External manufacturing of complete kits under GMP and/or ISO13485 is available and can be organised by shard-dx™.
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.

The shard-dx™ OEM process for custom kits

Step 1: Initial consultation

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Our process begins with a comprehensive consultation to understand your needs. During this phase, our experts will:

Take time to carefully understand your business and positioning.
Discuss your goals and objectives.
Identify the specific targets and sample types you are looking at if it's not covered by our existing off-the-shelf kits.
Gather detailed information about any special requirements or constraints.
Discuss our OEM licensing options.

This thorough understanding allows us to tailor a PCR kit that aligns with your business. The consultation process may be ongoing depending on the size and complexity of the kit.

Step 2: Custom design

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Based on the insights gathered during the consultation, our team of experienced scientists will design a custom PCR kit. This step involves:

Selecting the optimal oligonucleotides for high specificity and sensitivity.
Choosing the best reagents to maximize performance.
Designing the kit components to be user-friendly.

Our design process is meticulous, determining that every element of the kit is optimised for your specific application. For more complex kits or larger kits we can integrate multiple sign-offs during the optimisation process.

Step 3: Quality control

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Step 4: delivery and support

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Once your kit is completed, we can either send bulk components to you, white-label manufacture the kit or have it manufactured under ISO13485 through our recommended routes. Our commitment to your success doesn’t end with delivery.
We provide:

Detailed documentation and user manuals to guide you through the setup and use of the kit.
Ongoing technical support to assist with any questions or troubleshooting needs.

Book an OEM kit consultation

Information

Products

Custom Kits

Contact Us

Location:

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

Email:

info@shard-dx.com

OEM kits and technology

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

Trusted expertise

Full support

Superior performance

Globally scalable

shard-dx™ Technology

The shard-dx™ OEM process for custom kits

Book an OEM kit consultation

Information

Products

Custom Kits

Contact Us

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.