FDA Level Next-Generation Sequencing NEW! SeqWright is proud to offer Customized, Regulatory, Next-Generation Sequencing on the Roche 454 GS-FLX Titanium platform. Roche 454 technology provides extremely in-depth coverage; allowing for detection of very low percentage target sequences, a valuable parameter for validating highly sensitive genetic tests. Sanger Sequencing, which remains the gold standard for genetic validations, lacks the sensitivity to identify low percentage targets in clinical or viral repository samples. The Roche 454 platform, with a limit of detection as low as 1%, can be used as a reference method for validating these low percentage samples and can also be especially useful for SNP analysis in tumor samples. SeqWright has successfully completed numerous FDA/Regulatory Sanger Sequencing projects and now adds Regulatory Compliant Roche 454 GS FLX Titanium service to its portfolio. This Roche 454 GS FLX Titanium service offering includes a pre-developed proprietary validation protocol to meet FDA Submission requirements and tailored to customer specific project requirements. SeqWright can also perform assay design or receive assay sequences from the customer. Each project includes a complete study-specific validation protocol and final report, including all data, ready for FDA submission. Contact us today for more information.
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