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Illumina Launches TruSight HLA Solution

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Illumina, Inc. (NASDAQ:ILMN) today announced the launch of TruSight(R) HLA, a complete, end-to-end solution that produces a comprehensive view of the HLA region by sequencing 11 HLA genes for accurate HLA typing across thousands of known and novel HLA alleles. Leveraging the MiSeq(R) Sequencing System, the kit includes the TruSight HLA Sequencing Panel, a single assay for ultra-high resolution analysis of all the key genes within the major histocompatibility complex (MHC), reagents for preparing and sequencing DNA libraries, and optimized data analysis with software from Conexio Genomics.

“Next-generation sequencing has great potential for HLA typing, but it has not been widely adopted beyond a few specialized laboratories,” said Matthew Anderson, M.D., Ph.D., Medical Director, BloodCenter of Wisconsin. “Our evaluation of TruSight HLA demonstrates the benefits that NGS technology can provide with a single, accurate, multi-locus assay that provides the resolution required to make confident HLA calls. TruSight HLA will enable more laboratories to harness the power of next-generation sequencing for HLA typing.”

HLA plays a large role in the body’s ability to recognize invasive cells and mount an immune response thus helping to fight disease and maintain overall health. This region of the genome is notoriously challenging to study due to high levels of sequence homology and dense variability. Currently the standard typing protocol requires 10 to 20 assays in two or three sequential rounds of testing to generate a high confidence HLA type with results based on about 6,500 base pairs of DNA sequence. TruSight HLA uses a single assay and generates results based on 65,000 base pairs, a ten-fold increase in sequence coverage, which significantly streamlines the workflow while greatly expanding the capacity to discover novel alleles.

TruSight HLA leverages Illumina sequencing by synthesis chemistry, the most trusted NGS technology. HLA typing researchers can use the solution to replace the multiple rounds of testing and the dozens of assays currently necessary to resolve ambiguous results. Through a streamlined workflow and multiplexed samples, this single assay and tightly integrated software enable labs to reduce hands-on time, decrease costs, improve productivity, and increase confidence in the results, while generating unambiguous, phase-resolved HLA typing results in less than four days.

“The HLA region of the genome plays a critical role in autoimmune disorders, cancer, transplant rejection, and drug sensitivity, but conventional technologies cannot efficiently sequence the region,” said Kirk Malloy, Senior Vice President and General Manager of Illumina’s Life Science Business. “By providing researchers with a reliable, faster, easier, more comprehensive method of HLA sequencing, TruSight HLA is one of many examples of how next-generation sequencing technologies from Illumina can be applied to new markets where unlocking the power of the human genome holds great potential to make a positive difference in people’s lives.”

The TruSight HLA is now shipping. For more information, visit www.illumina.com/HLAseq.

About Illumina

Illumina is transforming human health as the global leader in sequencing and array-based technologies. The company serves customers in a broad range of markets, enabling the adoption of genomic solutions in research and clinical settings. To learn how Illumina is unlocking the power of the genome, visit www.illumina.com and follow @illumina.

Forward-Looking Statements

This release may contain forward looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements include challenges inherent in developing, manufacturing, and launching new products and services and the other factors that are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

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