Prostate biopsy is essential to the diagnosis and treatment of prostate cancer, the 2nd most deadly cancer afflicting men and estimated to kill more than 29,000 men in the US in 2014. However, PSA screening is not specific at identifying prostate cancer, and only about 20% of prostate biopsies performed find high-grade prostate cancer. Prostate biopsy causes many men to experience extreme anxiety and is accompanied by pain, bleeding and about 4% of the time infection caused by the biopsy procedure. The 4Kscore Test provides a patient-specific probability for finding a high-grade (Gleason score 7 or higher) prostate cancer upon biopsy. The information can be used by the Urologist to have an informed discussion with the patient about whether or not to have a prostate biopsy. The 4Kscore Test measures four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodule, no nodule), and prior negative biopsy (yes, no). The 4Kscore Test then provides a % probability on a scales from <1% to >95% for the patient having high-grade prostate cancer.
The 4Kscore Test can help reduce the number of unnecessary biopsies, by providing information to improve decision making before ordering a prostate biopsy. By avoiding unnecessary biopsies, associated complications and costs can be reduced, while delaying diagnosis of high-grade prostate cancer in very few individuals. Urologists can more confidently choose to place a low-risk patient under active monitoring or perform a biopsy on a high-risk patient based on their clinical evaluation, enhanced by the 4Kscore Test result.
The 4Kscore Test has undergone extensive clinical development and confirmation. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at the Memorial Sloan Kettering Cancer Center and leading research centers in Europe, encompassing over 10,000 patients. The results have recently been replicated in a prospective, blinded clinical study conducted at 26 urology centers across the United States on 1,012 patients.
Based on the results of the U.S. Clinical study, as many as 30-58% of biopsies are avoidable using the 4Kscore Test. The actual risk cut off used will vary based on an informed, shared decision-making process between the Urologist and the patient. For instance, a younger patient with clinical symptoms or family history may opt for a lower cut off, while a man 70 years old with co-morbidities may opt for a higher risk cut off.
In the United States, about 1 million prostate biopsies are performed every year. A recent health economic analysis estimated the 4Kscore Test could potentially deliver an annual savings approaching $1 billion in the United States. The savings is built on eliminating unnecessary prostate biopsies and avoiding the costs associated with the biopsy procedure, and the side effects such as infection and hospitalization.