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Illumina Aims to Have FDA-Cleared Dx, CLIA Lab In ‘09; CEO Says Arrays Have Dx Future

Taking its initial steps into the molecular diagnostics market, Illumina this week said it hopes to have an array-based assay cleared by the US Food and Drug Administration and to open a Clinical Laboratory Improvement Act-compliant laboratory by the middle of next year.
The firm’s first assay, which the company plans to submit to US regulators in the first quarter of 2009, will run on its digital microbead-based BeadXpress reader, while the CLIA lab will offer both sequencing and array-based services, a sign that Illumina believes these two platforms may play a larger role in its diagnostics offering in the future.
“We expect FDA approval shortly thereafter; it could move into the second half of ’09, depending on how long the FDA takes with their clock,” according to Greg Heath, senior vice president and general manager of Illumina’s diagnostics business unit.
Speaking during the firm’s Analyst Day Nov. 6, Heath did not discuss the indication that the first test will cover, but said that “oncology is the sweet spot of growth in molecular diagnostics,” and discussed ongoing research programs in ovarian and gastric cancer.
He made his remarks two months after Chief Financial Officer Christian Henry pledged that Illumina will begin to earn some diagnostics revenues in the next few years (see BAN 9/23/2008).
And both officials’ comments went beyond remarks CEO Jay Flatley made in June when he told investors that the company is “working very hard to try and understand what part of the diagnostics market Illumina can go into to become a significant player and contribute in a significant way to our revenue.”
Flatley also said at the time that Illumina could begin commercializing its first tests by 2010, and that by 2013 revenues from molecular diagnostics could account for up to a quarter of Illumina’s sales (see BAN 6/17/2008).
BeadXpress is an ideal diagnostics platform because it costs less than $100,000 and it can support a variety of applications, including genotyping, gene expression, methylation, and protein analysis, Heath said. He added that Illumina will attempt to build a suite of BeadXpress assays via internal development as well as through partnerships.
In terms of partnerships, Illumina will “offer our partners a no-royalty program which essentially allows them to build assays on our platform together with us,” Heath said. In return, Illumina will retain manufacturing rights, enable development of laboratory-developed tests, maintain rights to kitted IVD tests, and provide full kits for required reagents, he said. Illumina already has “several” such partnerships in place, Heath said, including in blood typing, pharmacogenomics, and prenatal testing. He declined to disclose them.
‘Limitation of Imagination’
Heath also said that the CLIA lab Illumina hopes to open by the middle of next year will offer BeadXpress-based assays and sequencing and array-based services.
According to Heath, the lab is “essential” for rolling out Illumina’s pipeline of tests. “Because of a long regulatory pathway, we want to be able to offer laboratory-developed tests earlier” through the lab, he said.
While Illumina has ruled out using arrays for the tests it initially plans to launch, including the assay scheduled to debut by the middle of 2009, CEO Flatley told BioArray News this week that the company could offer array-based services through the lab  to, for instance, its consumer genomics partners 23andMe and Decode Genetics.

“We believe that there will be consolidation of the consumer and personal diagnostic markets.”

Illumina originally provided array-based services for direct-to-consumer genomics firm 23andMe, but that company moved to using Laboratory Corporation of America’s CLIA-compliant lab earlier this year after a squabble with regulators in New York and California (see BAN 7/22/2008).
Flatley this week also said he believes that eventually the consumer genetic-testing  market will consolidate with the broader diagnostics market so that patients screened for genetic mutations by 23andMe, for example, could also receive a series of diagnostic tests on the same array-based assay.
“We believe that whole-genome genotyping will be done as a standard of care in about five years,” Flatley said. “If it doesn’t happen, we should be disappointed because it won’t be the result of a limitation of our technology, it will be because of a limitation of our imaginations or our infrastructure.”
Still, Flatley said that the “economics of doing DNA-based diagnostics on a single chip will be compelling” by the time the two segments converge. “It’s going to be so cheap and so easy, you’ll have instant access to the information,” he said.  
Flatley admitted that DTC genetic testing is likely to remain a “rich and famous” market for the next few years, but that as the price drops well below $1,000 — 23andMe recently cut its price from $999 to $399 while the DecodeMe service is still in the $1,000 range — the tests stand a greater chance of being used in standard care.
“We believe that there will be consolidation of the consumer and personal diagnostic markets,” Flatley said. “At the end of the day, diagnostics and consumer markets become indistinguishable; they will become one single market.”
Illumina will be chasing a small but growing number of rivals in this space, among them Mukilteo, Wash.-based CombiMatrix, which in 2005 opened its CombiMatrix Molecular Diagnostics subsidiary in Irvine, Calif., to offer a line of lab-developed tests. It received CLIA certification the following year.
Also in 2006, Affymetrix opened a CLIA lab in Sacramento, Calif. Today, several Affy partners, including Pathwork Diagnostics and Navigenics, another DTC testing startup, rely on services provided by Affy’s clinical services lab. 
Market Target
According to Heath, the entire diagnostics market is worth about $80 billion worldwide, $45 billion of which is in vitro diagnostics, which is growing at a rate of about 7 percent each year. Within the IVD market, the molecular diagnostics space is currently worth about $3 billion and growing 16 percent annually.
Meantime, array-based tests made up around $160 million, or a little more than 5 percent, of the total molecular diagnostics market in 2007, according to Harry Glorikian, managing partner of Boston-based consultancy Scientia Advisors. By 2012, that portion is projected to grow to $660 million, or around 9 percent of the molecular diagnostics segment, which itself is expected to reach around $7 billion by that time (see BAN 10/28/2008).
Heath said that the bulk of the molecular diagnostics market is infectious-disease testing based largely on amplification technologies, like PCR and branched DNA. “As we look out to the future, though, we anticipate most of the growth is going to come in the spaces of oncology and pharmacogenomics,” Heath said. “Oncology is the sweet spot of growth in molecular diagnostics.”

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