Dutch molecular diagnostics firm Agendia will use $23 million in recently raised Series E financing to bolster its US operations, according to the firm.
The financing was led by an undisclosed family investment firm that provided approximately half of the funds, Agendia said. In addition, two independent entrepreneurs invested $1 million each, while the remaining capital was raised through Agendia's existing investor base, which includes the Netherlands-based Van Herk Biotech and Gilde Healthcare Partners, and Germany's Global Life Science Ventures.
Agendia CEO Bernhard Sixt told BioArray News that the funds would be spent on accelerating the commercialization of MammaPrint, an array-based service that uses a 70-gene-expression signature to identify breast cancer recurrence and guide patient treatment.
"The proceeds will serve to ramp up the US commercial organization, double the sales force, and reinforce marketing, reimbursement, regulatory, and operational support," Sixt said.
Those activities could help the privately held firm score additional market share in a landscape currently dominated by Redwoods City, Calif.-based Genomic Health, which has offered its Oncotype Dx breast cancer prognostic since 2004.
The US Food and Drug Administration cleared MammaPrint for clinical use in 2007 (see BAN 2/13/2007). In May of this year, Agendia, which maintains its headquarters and operates a lab in Amsterdam, opened a Clinical Laboratory Amendment Improvement Acts-compliant lab and operations hub in Huntington Beach, Calif.
"Together they have ample capacity to support the growth of the company in the years to come," Sixt said of the two labs. He added that the Huntington Beach facility is "fully operational and receiving samples from the US market."
Sixt said in a statement last week that Agendia was able to raise $23 million due in part to "increasing US demand, as well as growing reimbursement from private US payors."
This week he declined to provide the number of samples the firm has processed from US customers since MammaPrint's launch, but characterized growth as "exponential." Sixt said that Agendia currently serves 200 US hospitals and clinics and "15 of the top 50 cancer hospitals" in the US.
In terms of reimbursement, Sixt said Agendia was covered previously by "several" Blue Cross Blue Shield associations responsible for around 3 million people. In August, though, Humana, which covers around 11 million people, and United Healthcare, which covers around 25 million people, decided to include MammaPrint in their coverage, he said.
"We are at present collecting payments from some 15 payors, such as Aetna, Cigna, Assurant, and HealthNet," Sixt said. He added that Agendia is in "advanced discussions" with the US Centers for Medicare & Medicaid Services regarding Medicare coverage for MammaPrint.
Agendia has developed other array-based assays for both diagnostic and research purposes.
TargetPrint, released last year, is designed to help physicians guide treatment by quantitatively determining the gene-expression levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 in breast cancer tumor biopsies.
CupPrint, which received a CE mark in 2006, uses a gene-expression profile signature licensed from bioMérieux unit Biotheranostics to determine tumor-of-origin in patients with cancer of unknown primary. DiscoverPrint, launched in 2003, enables collaborators to profile gene-expression in samples during clinical trials.
All arrays used by Agendia are manufactured by Agilent Technologies. Sixt said that all of Agendia’s products are available through its European and US labs with the exception of CupPrint, which is available in Europe only.
One of the main competitors Agendia faces with MammaPrint is Genomic Health, which has offered Oncotype Dx, a RT-PCR-based service designed to assess the risk of breast cancer recurrence and predict a patient's response to chemotherapy used to treat the disease.
While Sixt acknowledged that Genomic Health is a competitor, he noted that "before anything else" Agendia is competing with "the current clinical setting" — the "traditional method of analyzing tumor samples" rather than other products or services.
Sixt said that genomic tests like MammaPrint are new and that there is a need to "educate health professionals and patients about their benefits and demonstrate to them the improvements that can be obtained" by adopting new technologies.
Sixt credited Genomic Health with having done a "great job in raising awareness and showing that this is a viable market," and said the firm has "clearly benefited" from "first-mover advantage."
Indeed, Genomic Health posted $35.2 million in sales of Oncotype Dx for the second quarter, up 34 percent from the $26.3 million it derived from Oncotype Dx sales in the second quarter of 2008.
Still, from Sixt's perspective, MammaPrint is a "more advanced and much more accurate second-generation service" that will, in time, overtake [Oncotype Dx], very much like second-generation monoclonal antibodies have overtaken the first generation products."
Representatives for Genomic Health did not respond to an e-mail seeking comment.