Mayo Collaborates With Startup Focused On Prostate Cancer Marker Testing
A close collaboration between Mayo Clinic researchers and a venture-backed startup focusing on prostate cancer is breaking new ground in the search for genetic biomarkers capable of predicting whether patients are likely to develop a serious form of the disease.
Mayo was an early partner of privately-held GenomeDX Biosciences Inc. of San Diego, which, according to SEC filings, raised $25 million in a March venture financing round.
GenomeDX and the Rochester clinic have had close ties since 2009, when a Mayo team led by urologist Dr. R. Jeffrey Karnes played a key role in the development of the company’s Decipher Prostate Cancer Classifier, described as “the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of (prostate-specific antigen) and other conventional risk-assessment tools.”
The company says Mayo has an unspecified financial interest in Decipher.
Since then, the two parties have expanded their research collaboration. In April 2013 it was broadened to include an “exclusive license” to “certain co-developed and Mayo-developed intellectual property,” as well as allowing GenomeDX “continued access to the clinical data concerning Mayo Clinic’s cohort of prostate cancer samples to allow for longer term follow-up and evaluation of biomarkers.”
The next year, the research agreement was further expanded to include a validation study demonstrating how the Decipher test could be used for prostate patients receiving biopsies. That collaboration resulted with the introduction in March of a new product: Decipher Biopsy, touted as “a genomic test that evaluates RNA expression-based biomarkers to predict the risk of high-grade disease, metastasis and cancer-specific death at the time of biopsy in men with prostate cancer.”
The introduction of Decipher Biopsy coincided with GenomeDX’s new financing round. The company’s earlier financial backers include Tekla Capital, Baird Capital Management, Capital AG and the Merck Global Health Innovation Fund.
Meanwhile, Mayo’s Dr. Karnes, along with GenomicsDX bioinformatics expert Hussam Al-Deen Ashab and fellow researchers from Johns Hopkins University, the Cleveland Clinic and elsewhere, this month are presenting new studies claiming to validate further applications for Decipher in prostate cancer – specifically how to predict which patients will be resistant to androgen deprivation therapy (ADT), a hormone therapy that is one the main treatment options.
Patients who have an innate or acquired resistance to hormone therapy frequently progress to a more serious form of the disease, Neuroendocrine prostate cancer (NEPC), after the therapy is tried. Karnes was selected to present the results of a new study claiming to demonstrate how the Decipher test can predict innate ADT resistance at the 2016 American Society of Clinical Oncology annual meeting, held June 3-7 in Chicago.
The ability to use a genetic test to predict which prostate cancer patients will be resistant to hormone therapy could have significant benefits both medically and to the financial backers of GenomeDX. Medically, it could allow doctors to better select which anti-cancer course to pursue. Many grey areas exist in prostate cancer treatment, including when to introduce or move on from hormone therapy. Knowledge of a genetic predisposition for rejection of ADT would allow doctors to focus on chemotherapy or other alternatives earlier.
It could also help further prostate cancer research, allowing scientists to delve into how resistance to hormone therapy is acquired vs. when it is naturally predisposed. By identifying innately resistant patients through genetic testing, they could be recruited for clinical trials looking at alternative strategies for non-responders.
Financially, it could expand the market applications for Decipher at a time when the demand for cancer biomarker technology is quickly expanding. According to some reports, the worldwide market for cancer biomarkers, estimated at $9.2 billion in 2015, will expand to $17.7 billion by 2020, a growth rate of nearly 14 percent annually.