This story was originally published Aug. 30.
Illumina is building out its clinical and medical affairs group as it prepares to submit several products to the US Food and Drug Administration, and as a result is planning to hire an associate director of medical affairs this year. The new position will report to the company's chief medical officer Daniel Grosu, who joined Illumina late last year.
According to Greg Heath, senior vice president and general manager of Illumina's Diagnostics unit at Illumina, over the past several years the company has been expanding its diagnostics products business mostly on the research and development side by hiring scientists and bioinformaticians.
Now, as the company prepares products for FDA submission, it is "building out commercial and clinical infrastructure to support things like … clinical trials and outreach to the medical community because we need to educate them more on genomics and sequencing technology," Heath told Clinical Sequencing News.
Heath said the company plans to submit both sequencing- and array-based diagnostic products to the FDA this year. Additionally, the company is in the midst of planning a number of clinical trials for other diagnostic products.
The clinical and medical affairs group will operate under Grosu and within the Diagnostics business unit of Illumina.
Last year Illumina launched another clinically focused business segment, Translational and Consumer Genomics, that is headed by Matt Posard (CSN 3/12/2012). That unit, which doesn't fall within the Diagnostics business, focuses mainly on collaborating with laboratories that want to develop their own laboratory-developed tests, said Heath, so the "burden for validation resides with the lab."
The clinical and medical affairs group, meantime, will be focused on launching Illumina's own diagnostic products, so the company itself is responsible for providing clinical evidence to the FDA.
Illumina would not disclose how many people it plans to hire within the clinical and medical affairs group, but Heath said that it will be based on the project load and will likely expand over the years.
The main role of the associate director of medical and affairs will be to act as a liaison to both physicians and regulators.
On the physician side, the associate director of medical affairs will help educate physicians about next-gen sequencing and will eventually act as the point person for feedback on the company's diagnostic products.
"There's a definite unmet need in educating the physician community around next-gen sequencing and its capabilities," Heath said. "Physicians don't get a lot of genetics training in school unless they become medical geneticists."
Illumina is also involved in a number of diagnostic development projects that will require clinical trials in the future and "there is a lot of infrastructure around that," including consenting patients, structuring the trial, reviewing the trial format and statistical analysis plan with the FDA, and making sure the language around the intended use is clear and accurate, he added.
"The FDA will clear a product, but will clear it for a specific use including the hardware, software, and reagents," Heath said.
The company plans to submit several diagnostic products — both microarray- and sequencing-based — to the FDA this year in the field of genetic disease, said Heath.
He said that the company also sees significant opportunities for its technology in cancer, transplantation diagnostics, and immunology.
The "low hanging fruit in sequencing is genetic disease, but [the technology] will also play a significant role in cancer, because you can only get this high resolution with next-generation sequencing."
Heath predicts that Illumina's Diagnostics business will grow significantly in the coming years, and as a result "we'll need more and more of this expertise," he said. "As a research company, we don't have a lot of that in-house, so building out the medical capabilities will be critical."