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Illumina Continues Push into Oncology, Reproductive Health; Fine Tunes its 'Clinical Readiness' Strategy


This article was originally published July 25.

NEW YORK (GenomeWeb) – The clinical market is becoming an increasingly larger portion of Illumina's business, particularly in the areas of oncology and reproductive health, and as such the firm has tripled the size of its regulatory team as it prepares to bring products through US Food and Drug Administration clearance.

In a conference call discussing its second quarter results, Illumina officials outlined the progress the company has made on the clinical front. For specifics around Illumina's individual next-gen sequencing systems and sample prep products, see In Sequence's coverage, here.

As has been the trend over the last year, an increasing number of customers are outside of academia, including commercial, hospital, and nonprofit customers doing clinical and translational work. In the US, clinical orders grew by more than 50 percent in the second quarter.

The MiSeq system in particular is doing well in the clinical space, with two-thirds of shipments to translational, commercial, and clinical customers, including "follow-on, multi-unit orders from customers building capacity in production unit facilities and from public health institutions" including the FDA and the US Centers for Disease Control and Prevention, Illumina CEO Jay Flatley said on the call.


Sales to customers in the oncology space, which includes customers doing oncology research as well as clinical customers, grew more than 30 percent in the second quarter compared to Q2 2013, accounting for nearly $90 million in sales.

This quarter, Illumina hired Tina Nova to head its oncology business. Previously, Chief Medical Officer Richard Klausner had been serving as interim head of oncology.

Flatley said that in the coming quarters the firm will make announcements about its work with pharmaceutical companies regarding the development of an Onco Panel, which Illumina would submit for FDA clearance.

In addition, it has an agreement with Amgen to develop a companion diagnostic for its colorectal cancer drug Vectibix (panitumumab). Illumina plans to bring this test through FDA approval, and Flatley said that it is in discussions with other pharmaceutical companies about developing CDx tests.

Reproductive health

Illumina ran record numbers of its Verifi noninvasive prenatal test for fetal aneuploidy this quarter, Flatley said, and is on track to submit the Verifi test on the HiSeq 2500 to the FDA this year.

The company also signed technology transfer agreements with French medical testing firm Biomnis, Italy's molecular diagnostic laboratory Genoma, and the Center for Human Genetics and Laboratory Diagnostics in Martinsreid, Germany. Under these agreements, Illumina will work with the laboratories to develop their own noninvasive prenatal tests on the HiSeq 2500. In addition, Flatley said that the company is currently in discussions with "more than a dozen other potential customers" for similar technology transfer agreements.

Also within the reproductive health space, Illumina announced earlier this month that it had partnered with Chinese firm Berry Genomics to bring its noninvasive prenatal fetal aneuploidy test, Bambni, through the China FDA for clearance on a customized version of the NextSeq 500. Flatley said on the call that the system has been validated in a clinical setting and is in late-stage review by the CFDA.

He also said that the company made some changes to the instrument manufacturing process, software, and sample prep in order to make it "suitable for the Chinese market."

According to Flatley, the NIPT market in China is less segmented than the US market in terms of high-risk versus low-risk, and he said that NIPT would reach the broader population in China faster than in other countries. The cost of a test will also be lower in China, Flatley said, likely around $300.

The NextSeq 500 will play a critical role in the NIPT market, especially in markets that are more distributed, he added. In the US, where noninvasive prenatal testing is centralized to large laboratories, the HiSeq will be the better option because of the large sample flow and the lower cost per read, Flatley suggested. But in markets like China, where there may be 3,000 hospitals doing NIPT, the NextSeq 500 will be a better product because it "multiplexes at the right kind of level to deal with the more moderate sample flow," he said.

The company also plans to make its VeriSeq test for preimplantation genetic screening, which it launched this spring on the MiSeq, available on the NextSeq 500 this year.

Regulatory strategy

As Illumina plans to bring more products through the FDA, the company is looking to bolster its regulatory team, Flatley said. As part of that "clinical readiness strategy," it acquired regulatory and quality consulting firm Myraqa earlier this month. The addition of Myraqa tripled the size of Illumina's regulatory team and will allow the company to "run a broad parallel portfolio of regulatory products through our pipeline," Flatley said.

"We need to run products through clearance cycles at a pace that almost no other company has ever done," Flatley said, and he believes Myraqa will provide the necessary resources for Illumina to do this. Typically, the FDA grants two to three pre-market approvals per year, he added, but Illumina is going to "try to push a whole bunch of products through there in the next three years."

Such products will include an oncology panel, companion diagnostics that it develops in collaboration with pharmaceutical companies, the Verifi test, and a product that Illumina will develop as a the result of its actionable genome consortium, Flatley said.

The company does not plan to sell tests directly to physicians that will run out of Illumina's own laboratories. Rather, Flatley said that Illumina will sell such products as a "bundled solution that includes the kit, the software, the instrument, the analytics, and the cloud support."