The future of healthcare is moving towards precision, a.k.a., personalized medicine—and molecular diagnostics play an increasingly important role in one of the main components of precision medicine, gene-specific therapeutics.
Irvine-based Agendia Inc. is a player here with big plans to grow its breast-cancer testing platform following last week’s close of a $35 million investment from Athyrium Capital Management LP.
Proceeds will support commercial expansion of its MammaPrint test, which assesses a patient’s risk for breast cancer recurrence, and BluePrint test, which subtypes a breast cancer sample into three categories—each differs in response to chemotherapy. Funding will also help develop big data programs in the U.S. and Europe—named Flex and Precise, respectively.
Chief Executive Mark Straley said the New York-based healthcare investment firm provided capital, but also strategic value-adds as an investor in biopharmaceutical companies.
Along with the funding, Athyrium will be represented on the Agendia Board with the appointment of a director. Straley said the candidate has not been finalized. The addition will increase the board size to six.
Breast Cancer
The funding comes at an opportune time—Straley told the Business Journal. The company has seen improved reimbursement and coverage from Centers for Medicare and Medicaid Services and private insurers over the past 12 to 18 months, which speaks to the clinical utility of molecular diagnostics.
“Since publication of the landmark MINDACT trial in 2016, MammaPrint has been recommended in major international clinical practice guidelines and reimbursed by most healthcare insurers in the U.S.,” he said, pointing out that the company has seen double-digit growth over the period.
The randomized phase-3 study enrolled 6,693 women with early-stage breast cancer and used MammaPrint to identify patients unlikely to see any significant benefit from chemotherapy based on their genomic and clinical risk results. It is the only test of its kind recommended by the American Society of Clinical Oncology for lymph-node positive breast cancer patients.
The company has a pipeline of other genomic products for other types of cancer in development in collaboration with pharmaceutical companies, cancer centers and academic groups, but Straley said it will focus on expanding its breast cancer testing platform over the course of the next five years. It expects to break-even on cash flow this year.
International
Agendia was founded in 2003 as a spin-off from the Netherlands Cancer Institute of Antoni van Leeuwenhoek Hospital in Amsterdam. In 2004, it launched its first test, MammaPrint 70-gene breast cancer recurrence test, in Europe. That test received clearance from the Food and Drug Administration in 2007, making it the first multi-gene test cleared by the agency, according to the company. It became commercially available in the U.S. in 2008.
MammaPrint has received additional FDA clearances, including its sixth and most recent in 2015 for MammaPrint FFPE, which eliminates the ambiguity of intermediate results for cancer recurrence by providing a binary low or high risk result.
Agendia is dual-headquartered in Irvine and Amsterdam. It employs 166, including about 100 locally. Straley said U.S. remains its largest market, accounting for about 80% of test revenue.
He said the funding will help the company “expand opportunistically” and it plans to open an office in the Asia Pacific region.
Flexibility
Agendia’s new round of financing is the first large outside investment since its fifth and last VC round of $23 million in 2009. Swiss drug developer Debiopharm Group led a $65 million private equity round in 2012, with a mix of current and new backers. According to Crunchbase, a public database of private company financings, Agendia has raised $182 million since its inception.
The new funding provides growth capital and flexibility.
“All options are open,” Straley said, not discounting a merger or acquisition. He said the company is in the early stage of planning its capital deployment.
Straley, who joined the company nearly three years ago, said he was brought on when the company was looking for a chief executive with commercial background to drive growth. He arrived with more than 25 years of international experience developing and commercializing clinical diagnostics and laboratory services and was most recently president of anatomical pathology of Waltham, Mass.-based biotech company Thermo Fisher Scientific.
Straley succeeded Jan Egberts, who took on the position in 2014 as interim chief executive, replacing former chief executive David Macdonald.
