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Illumina Expands Clinical Business Internationally; Discounts NovaSeq Flow Cells

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SAN FRANCISCO (GenomeWeb) – Illumina is expanding its clinical business in international markets with clearances of its sequencing instruments and partnerships with diagnostic companies, the company said on Tuesday.

In addition, during a conference call with investors to discuss its fourth quarter and full-year 2018 performance, CEO Francis deSouza said that the firm plans to reduce the costs of two of its lower-throughput NovaSeq flow cells, the S1 and S2, by 25 percent and 10 percent, respectively, in order to drive adoption of the system in smaller labs. The firm sold around 315 NovaSeq instruments in 2018, fewer than the 330 to 350 it had previously anticipated.

It also plans to launch its S Prime flow cell in February. The S Prime flow cell, which Illumina announced earlier this month at the JP Morgan Healthcare conference, is designed to target customers who currently use the rapid run mode of the HiSeq 2500. Illumina launched NovaSeq in 2017, and has so far sold around 600 instruments. However, still nearly 75 percent of its HiSeq customers have not yet ordered a NovaSeq.

The new SP flow cell and reduced costs of the S1 and S2 flow cells "will let lower-throughput customers sequence on demand rather than waiting to batch" samples, deSouza said during the call. The company does not plan to make any changes to its S4 flow cell.

Illumina is also making progress in the clinical market internationally. The firm secured approval of its NextSeq 550Dx instrument from Japan's Pharmaceuticals and Medical Devices Agency in November and deSouza said that Illumina is now collaborating with Sysmex to commercialize a 114-gene oncology in vitro diagnostic panel in Japan. The panel was developed by Sysmex and Japan's National Cancer Center.

In China, deSouza said, the firm is working with Beijing's ChosenMed, an oncology precision medicine company, which plans to use Illumina's TruSight Oncology 500 panel as part of the country's cancer genetic atlas project. DeSouza said that ChosenMed plans to use the TSO 500 panel as part of a grant to build a bank of 10,000 tumor samples.

In the noninvasive prenatal testing market, deSouza said, France's recent decision to reimburse NIPT for trisomy 21 screening at €360 ($411) in some pregnancies would help drive the NIPT market in Europe. Around 8 percent of pregnancies in France would be eligible for screening. 

NIPT also continues to "make headway" in Asia-Pacific, deSouza said, evidenced by the firm's first partnership in South Korea with BioGeno. He added that Illumina planned to continue to expand its presence in the NIPT market there in 2019.

In the US, changes in the regulatory and reimbursement landscape have had the most impact on Illumina's clinical business. For instance, deSouza noted that a Michigan health insurance plan called Priority Health issued a positive coverage policy specifically for whole-genome sequencing in acutely ill patients, while the US Centers for Medicare and Medicaid Services set a price of $5,000 for whole-genome sequencing tests. Private payor Aetna has also expanded its coverage to include exome sequencing for patients with rare and undiagnosed genetic diseases, bringing the total covered lives within that population to 147 million for exome sequencing, deSouza said. "Genomic testing is poised to become standard of care" for those patients, he said.

This month, state Medicaid programs in Pennsylvania and Ohio opted to cover NIPT for average-risk pregnancies, bringing the total number of states that cover NIPT in average-risk pregnancies to five, deSouza said. In total, around 46 percent of average-risk pregnancies are eligible for reimbursement while 96 percent of high-risk pregnancies are covered, deSouza said.

Later in the year, he said, the firm expects to see population sequencing projects pick up. The company is watching around 50 such programs, including the All of Us project in the US, as well as initiatives in Singapore, France, the UK, and elsewhere. Although the UK's 100,000 Genomes Project recently wrapped up, the country is moving sequencing into its National Health Service and has a goal of sequencing 5 million genomes over the next five years. France, meantime, plans to launch its pilot program to eventually be able to sequence 235,000 genomes per year, while Singapore aims to sequence 150,000 whole genomes.