For many men diagnosed with prostate cancer (PC), the outlook can be grim. According to Cancer.net, While the five-year survival rate for most with local or regional PC is nearly 100%, for those whose cancer has metastasized that rate drops to 30%. It is the second leading cause of cancer death in men in the US, with an estimated 34,130 deaths to happen in 2021 alone.
Researchers like Niven Narain (president, CEO, and co-founder of Berg) are hoping to help improve the outlook for PC patients by offering improved diagnostics. His company has conducted a study “Clinical utility of a serum biomarker panel in distinguishing prostate cancer from benign prostate hyperplasia” in collaboration with the Uniformed Services University (USU) Center for Prostate Disease Research and other key partners that underscores the benefits of using a biomarker panel.
Narain spoke with Outsourcing-Panel about the evolution of the PC biomarker panel, the study, and what lies ahead for this novel diagnostic solution.
Berg’s Cooperative Research and Development Agreement (CRADA) with the US Department and Defense and the Center for Prostate Disease Research began in 2013, with the goal of coming up with novel cancer diagnostics. According to Narain, the DOD was keenly interested in understanding the difference between PC in members of the military and civilians with regard to diagnoses and outcomes (research out of the Air Force suggests incidents of PC in pilots is much higher than the rest of the population).
“They wanted to know what this difference between the military and civilian population with respect to the incidence of PC is, and what may be driving that,” Narain said. He added that the DOD also was interested in using a creative approach and different research methodology because ones employed to that point in time “hadn't really led to an appreciable amount of insight.”
The team incorporated a data-driven approach in working on ways to improve and accelerate how PC and other cancers are detected, diagnosed, and treated. According to Narain, employing the company’s artificial intelligence-based Interrogative Biology platform made it possible for the research collaborators to come up with what is the first AI blood-based biomarker for managing PC as well as and BPH diagnosis.
“Our intent is that by enhancing clinical decision support that we will be able to establish a more efficient treatment paradigm and potentially reduce fiscal burden to healthcare systems around the world," he said.
In the PC biomarker study, Berg evaluated more than 750 patients at a diverse list of medical centers in the US and Canada. Researchers applied and evaluated the biomarker panel, which consists of filamin-A (FLNA), age, and prostate volume, to help predict and to stratify men with benign prostate hyperplasia (BPH) from those with PCa.
According to the findings, utilizing a biomarker panel can be useful in the following ways:
- differentiating patients with PC and BPH
- enhancing patient care in various ways, including reducing unnecessary, invasive biopsies
- avoid false negatives, which can delay accurate PC diagnosis and delay treatment
- offer a more effective tool to manage active surveillance.
Until now, according to Narain, there have not been any recent significant advancements in PC diagnosis—the typical choice is a prostate-specific antigen (PSA) blood test, followed by a rectal examination and biopsy. This path, he said, can be invasive, inaccurate, and costly.
Also, Narain said, while there have been notable advancements in research into PC diagnostic tools, this AI-based biomarker panel study stands out.
“There's certainly emerging technologies and emerging assays and approaches to constantly look at biomarker development in the prostate cancer world, but nothing like this test that was AI-developed,” he said.
Further, he added, the biomarker panel offers earlier detection than currently available diagnostics.
“It gives doctors another weapon in their arsenal against prostate cancer,” he said. “It helps get ahead of the disease.”
Narain pointed out the accelerated PC diagnosis offered by the biomarker panel could be especially good news for Black patients. According to research by the Memorial Sloan Kettering Cancer Center, Black men are 50% more likely than white men to develop PC, and are approximately twice as likely to die from the disease.
According to Narain, the team is working on its partnership and commercialization strategies and plans to get the diagnostic solution in doctors’ hands soon.
“Our goal is to have all the necessary steps completed and the test into doctors’ hands in the next 12-18 months,” he told OSP.
Narain added that while the biomarker panel does not yet have a price tag, he is confident that the diagnostic solution will cost far less than current options, in addition to offering other benefits.
“If the patient has an elevated PSA, the next logical step is taking a biopsy,” he commented. “That can cost $3,000 [USD], and it comes with a risk of infection—nobody wants to have to deal with that."
Other collaborators on the biomarker panel study include:
- John P. Murtha Cancer Center Research Program
- Walter Reed National Military Medical Center
- Henry M Jackson Foundation for the Advancement of Military Medicine
- University Health Network in Toronto
- Department of Laboratory Medicine and Pathology at Harvard Medical School and Boston Children's Hospital in Boston
- Mount Sinai Hospital in Toronto
- Department of Clinical Medicine at University of Oxford
- Center for Integrated Research in Cancer and Lifestyle
- Durham VA Medical Center