From new IVD assays to improving the formulation of an existing assay, our molecular assay development team quickly delivers prototypes and then scales to manufacturing. We specialize in bacterial expression systems and have flexible filling and lyophilization capabilities including cartridges, plates, and tubes. Manufacturing options also include kitting and warehousing.
Get rapid prototypes and then scale and document the manufacturing process in accordance wiht ISO 13485 QMS.
Molecular assay development and manufacturing of custom enzymes and master mixes.
Full lyophilization solutions. Simplify protocols, extend shelf-life, and improve assay repeatability.
Remove cold chain requirements, extend shelf life & reduce reconstitution variability. Bead, cake, & surface coating formats. Up to 6 million beads per month. Prototypes typically within 10 business days.
Improve sensitivity & decrease inhibition. Taq polymerases, CAS, master mixes, reverse transcriptases, and isothermal enzyme formulations developed and manufactured under ISO 13485.
Controls that behave like clinical samples- consistent dissolution, reliable signal. Lyophilized controls freeze-dried directly to medical-grade swabs. Stable at room temperature.
Improve plasma separation quality. PrimeCare™ asymmetric membranes separate plasma from whole blood in as fast as 60 seconds/cm². Pore size and anti-hemolytic coating customizable to your device architecture.
Molecular diagnostic platforms, sequencing technologies, and point-of-care systems are becoming increasingly specialized. These devices often feature microfluidic cartridges, ultra-low reaction volumes, rapid cycling protocols, and
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It's late evening in the laboratory. After months of painstaking research on specific genetic biomarkers for a diagnostic test, something has gone wrong. The PCR
Read MoreWe work to your defined assay specifications. If you don’t have these, we have ecosystem partners who can help.
Formulations and enzymes/proteins can be engineered by our team to increase sensitivity.
We manufacture under ISO 13485.
Earlier engagement changes what’s achievable and you should have developed your preliminary specifications. Reagent selection, format decisions, and detection chemistry all create downstream constraints.