Illumina Unveils Strategic Roadmap for Market Expansion

Illumina, Inc. has unveiled a strategic roadmap for moving next-generation sequencing (NGS) into new markets, leveraging its technology leadership and new organizational alignment around those markets to drive growth.

During an investor day where executives presented plans for this growth, Illumina also shared workflow innovations designed to simplify the sequencing experience and new market solutions derived from the company’s sample to answer technology base.

“Earlier this week we announced two transformative platforms that redefine next-generation sequencing, with the addition of the NextSeq™ 500 System and the HiSeq® X Ten to our market leading portfolio. Today we previewed additional innovations that position us to seize opportunities across research and clinical markets, as well as to deliver the industry’s simplest, most efficient sequencing experience to our customers,” said Jay Flatley, Illumina’s Chief Executive Officer.

Expanding the Use of Next-Generation Sequencing (NGS)
Illumina shared the following strategies and innovations around its core market targets.
• In reproductive health, Illumina will expand its offerings based on the verifi® laboratory-developed non-invasive prenatal test (NIPT), submitting an IVD version on the HiSeq® 2500 system for FDA premarket approval by the end of 2014. It also will offer an NGS-based solution for preimplantation genetic screening, VeriSeq™ PGS, launching initially on the MiSeq® system, as well as an array-based karyomapping single gene preimplantation genetic diagnosis (PGD) solution to identify embryos with genes associated with severe genetic disorders.
• In oncology, the company previewed a targeted sequencing strategy that includes supporting the clinical community with content. Illumina is also working in collaboration with the oncology community to develop test guidelines and infrastructure to build actionable cancer genomics solutions.
• In emerging markets, Illumina will launch a human leukocyte antigen (HLA) typing product in mid-2014 for laboratories seeking next-generation sequencing on the MiSeq® platform that will be faster, less expensive, and more accurate than current technologies. Additionally, the company introduced the MiSeq® Forensic Genomics System (MiSeq FGx), the first targeted forensic NGS system, which will simultaneously interrogate short tandem repeats and other valuable genetic markers to provide more comprehensive identification information from both challenging and standard biological samples. The complete sample to answer solution, including consumables and software, is expected to be available in the first six months of 2014.

Simplifying the Sample to Answer Experience
Illumina previewed the following products that simplify the end-user experience for sample preparation and analytics and further solidify the technology tool kit that can be used across markets to address customers’ needs for integration.

• NeoPrep™ is a push-button library preparation system that provides a radically simpler workflow to go from DNA or RNA to libraries ready for sequencing. It will prepare up to 16 libraries per run, starting from as little as 1ng of input for some assays. The first kits for NeoPrep will be TruSeq PCR-Free and TruSeq Nano, with other TruSeq and Nextera kits to follow. NeoPrep, expected to be available summer 2014, is an important step on the path to offering integrated, sample to answer solutions.
• BaseSpace® OnSite provides the BaseSpace® experience in a simple informatics appliance, enabling NGS users to securely stream data directly to a local solution for storing, analyzing, and interpreting genomic sequence data. BaseSpace® Onsite represents a turnkey solution and will be available in the first quarter of 2014.
• BaseSpace® Core Apps transform sequence data processing into a simple push-button process for the most frequently used sequencing applications. These highly optimized apps eliminate time spent configuring and maintaining software, and support RNA-sequencing, exome analysis, whole genome sequencing, and tumor/normal analysis. BaseSpace® Core Apps are available for BaseSpace® including BaseSpace® Onsite.

Paving the Way for Genomics in the Clinic
In November 2013, Illumina became the first company to receive FDA premarket clearance for a next-generation sequencing platform with its MiSeqDx system. Illumina will continue to pave the way for NGS in regulated markets with further submissions to the FDA, beginning with NIPT on the HiSeq® 2500, while also driving standards for the use of NGS in the clinic. In addition, the company will continue to build the infrastructure and means with which to deliver a best-in-class regulated products pipeline through its IVD Development group.

“Illumina’s technology is already making an impact in identifying undiagnosed diseases, and we will soon see it transforming fields like oncology and complex disease,” said Francis deSouza, President of Illumina. “The strategic roadmap presented today demonstrates our commitment to making NGS ubiquitous across markets, delivering simplified and integrated solutions to our customers, and paving the way for a new era in health care.”