IVD (In Vitro Diagnostics)

Trusted oligonucleotide component manufacturer for diagnostic assays

With over 20 years of experience in oligonucleotide synthesis, chemistry manufacturing and instrumentation, Biosearch Technologies has established itself as a reliable business partner for providing oligo components for in vitro diagnostic suppliers. Our state-of-the-art laboratories, superior quality reagents, ISO 13485 compliant standards and fully customisable, yet consistent production processes, make Biosearch Technologies the partner of choice for diagnostic test manufacturers.

Benefits and features that Biosearch Technologies has to offer:

• Simplify technology licensing requirements
• Choose from the largest selection of oligonucleotide modifications available 
• Minimise large and multiple capital investments 
• Scalable manufacturing tailored to your needs
• Rely on Biosearch Technologies’ extensive experience across all phases of manufacturing
• Manage regulatory constraints
• Accelerate the development of your molecular diagnostic project 

Biosearch Technologies has a project management team dedicated to providing personal consultation and support through every phase of your diagnostic product. For each product, we can:

• Discuss product details such as sequences, purity, synthesis scales and delivered amounts, chemistry, manufacturing and QC specifications, regulatory requirements, lead time, IP, etc.
• Support your quality and regulatory staff with FDA submissions by assisting with risk assessment, documentation, stability studies, etc.
• Provide help with oligonucleotide design, assay development, or application usage
• Give regular updates on the current production status

Since our introduction of the Black Hole Quencher™ (BHQ™) dyes in 2000, BHQ dyes have become the dark quencher of choice in the DNA marketplace. Other proprietary dyes include the CAL Fluor™ and Quasar™ dyes, which are vibrant, high performing fluorophores designed to perfectly complement the BHQ dyes. Biosearch Technologies can also manufacture many other dyes such as FAM, TET, HEX, JOE, etc., to supply any combination of fluorescence-quenched probes.

Biosearch Technologies offers flexible and different levels of licensing programs that can be tailored to the terms of your project. Partner with Biosearch Technologies so you can consolidate your oligo supply and dye licensing needs. Contact licensing@biosearchtech.com with any related questions.

Useful links

Learn more about our proprietary dyes from Biosearch Technologies.

Also check out our interactive spectral overlay tool.

Biosearch Technologies manufacturing services offer oligo components for every phase of product development

• Custom oligos for research - custom-synthesised oligos offered at low prices with the quickest turnaround; ideal for assay design.
• ISO 13485-Manufactured oligos - Oligo components for molecular diagnostic assays with defined batch record documentation released by QA; manufactured under controlled processes.

Our synthesis skill set includes:

• Fluorogenic probes and primers to fuel various platforms such as: real-time qPCR thermal cyclers, Luminex®-based systems and isothermal amplification
• Synthesis scales ranging from 25 nanomoles to several millimoles
• Unmodified oligos as long as 200 bases
• Synthesis of oligos with a vast selection of modifications, RNA, DNA-RNA hybrids, and other complex and rare specialty bases

Quality management

The Biosearch Technologies Quality Management System (QMS) within IVD oligo production is designed for compliance to ISO 13485:2016 and the requirements of 21 CFR Part 820 (as applicable). Our QMS documentation results in reproducible components that consistently meet the needs of our clients. Our production batch records provide full process traceability and undergo systematic scrutiny during Quality Assurance review and release.

For questions about the services we offer for molecular diagnostics, please email info@biosearchtech.com or call us: 1.800.GENOME.1 (436.6631).