A U.K. diagnostics startup is off and running, backed by nearly $21.3 million in financing to support development of a PET imaging agent for recurrent prostate cancer licensed from GE Healthcare.
Blue Earth Diagnostics is the new London-based company. Its founding CEO--Jonathan Allis--previously held the job of PET Imaging general manager at GE Healthcare. David Gauden, Blue Earth's new head of marketing, served as GE Healthcare's ($GE) product leader for PET Oncology, according to the deal announcement. Syncona Partners is the initial investor, with other potential rounds of funding expected down the line.
Prostate cancer is the second biggest cause of cancer death in men around the world, according to the company. With that in mind, Blue Earth is interested in [18F]-fluciclovine, or FACBC, a positron emission tomography imaging agent designed to work with recurrent prostate cancer. Blue Earth and its investor see opportunity in the space, considering about 35% of prostate cancer patients that get radical first-line treatment face disease recurrence not detectable through conventional imaging. So there's an opening for FACBC, if it can be shown to be safe and effective. The compound, a synthetic amino acid, has been shown previously to be able to detect local or metastatic recurrent prostate cancer. Blue Earth wants it registered for use for lesion detection and localization for prostate cancer patients facing a return of the disease.
Syncona, a Wellcome Trust subsidiary, launched in 2012 with a focus on spotting, supporting and developing technologies that can help improve the standard of care in the healthcare market.
FACBC has been tested in 500 patients so far, and studies are ongoing in the U.S., EU and Japan. While the company said that "results to date are extremely encouraging," its ultimate success is far from a sure thing. Blue Earth will need a much wider patient pool to test how well FACBC can spot recurrent prostate cancer and how easily patients can tolerate the substance. Better diagnostic detection of patients with prostate cancer recurrence will enable quicker and more targeted treatment, helping to address everything from survival prospects to health care costs.
GE Healthcare has had a mixed track record with imaging agents so far. The company finally nailed down FDA approval last year, for example, of a PET imaging agent designed to help evaluate living patients for Alzheimer's disease or dementia. But it can't be used to predict development of Alzheimer's or monitor how patients respond to a given Alzheimer's treatment. The Centers for Medicare and Medicaid Services (CMS) also declined to cover the use of PET scans to detect beta-amyloid buildup in dementia patients, though it would cover the procedure under certain limited conditions.
Yes, Alzheimer's PET imaging agents aren't the same as those designed for cancer. But it shows how high the bar is for the diagnostic tool in general, and Blue Earth will have plenty to prove in the months ahead. Even if the technology sails through further clinical trials, there's no guarantee that regulators and CMS will decide that it deserves wide use or coverage.
Ger Brophy, GE Healthcare's chief technology officer, said in a statement that PET agents "are crucial in clinical and research settings for a wide range of difficult diseases." He said that "broad partnership and licensing opportunities" such as its deal with Blue Earth are "a way of continuing our drive to increase access to new technologies in precision medicine."
- read the release
Navidea wants the FDA to approve a wider use of its injectable cancer imaging agent
GE Healthcare eyes 2014 for U.S. launch of Alzheimer's imaging agent