4Kscore News

New York, NY – Prostate cancer is the second most common cancer among men, and it is estimated that nearly three million men are living with the disease in the United States. Thankfully, many prostate cancers can be caught early on and either successfully treated or diagnosed as indolent (non-aggressive).

Early detection of prostate cancer begins with screening the Prostate Specific Antigen (PSA) to assess the health of the prostate. All men should get a PSA test, and know their PSA number and what it means. If a PSA test result is high, often times a doctor may recommend a biopsy. However, because the PSA test cannot distinguish between aggressive prostate cancer and other less serious conditions, many men with a high PSA may be subjected to unnecessary prostate biopsies.

Posted by 4Kscore on Dec 8, 2016 12:00:00 PM

OPKO Health, Inc. (NYSE: OPK) today announced that senior management will discuss recent draft local coverage determinations by certain Medicare Administrative Contractors for OPKO’s 4Kscore® test at the Jefferies Healthcare Conference in New York City on Thursday, June 9, 2016 at 11:30 AM (EDT). OPKO previously announced that Novitas Solutions issued a positive draft local coverage determination proposing to establish reimbursement coverage for patients with PSA levels > 3 ng/mL who have not yet had a biopsy, or patients with a PSA level of > 3 ng/mL who have had at least one prior negative biopsy and are considered to be at higher risk. The draft coverage determination was subsequently retired by Novitas due to a potential conflict with another Medicare Administrative Contractor. Palmetto GBA had issued a draft non-coverage determination on May 27^th for the 4Kscore test.

Posted by 4Kscore on Jun 17, 2016 12:00:00 PM

OPKO Health, Inc. (NYSE:OPK) (“OPKO” or the “Company”) announces that Novitas Solutions has issued a draft local coverage determination for the 4Kscore^® Test, the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive prostate cancer. Novitas Solutions is a Medicare Administrative Contractor (MAC) for Medicare jurisdictions L and H, with responsibility for nearly 10 million Medicare beneficiaries in New Jersey, Pennsylvania, Maryland, the District of Columbia and Texas, among other geographies.

Posted by 4Kscore on May 27, 2016 12:00:00 PM

OPKO Health, Inc. (NYSE:OPK) today announced the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore® Test in the 2016 EAU Guidelines for Prostate Cancer. The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

Posted by 4Kscore on Mar 15, 2016 12:00:00 PM

OPKO Health, Inc. (NYSE: OPK) announced today the results of a study for the 4Kscore® Test’s clinical utility in reducing the number of prostate biopsies performed, while increasing the probability of detecting aggressive prostate cancer in men with abnormal prostate-specific antigen (PSA) levels and or digital rectal examination (DRE) results. The peer-reviewed study, “The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices”, written by Badrinath Konety, MD, et al. and published in the January 2016 edition of Reviews in Urology, a MedReviews, LLC. Publication, which included 611 patients seen by 35 academic and community urologists across the United States, indicated that consideration of results from the 4Kscore tests led to 64.6% fewer prostate biopsies being performed among participating patients.

Posted by 4Kscore on Feb 9, 2016 12:00:00 PM

A new screening tool for prostate cancer has been shown to offer better accuracy than the test currently used by most physicians in the United States. The new test, called the 4Kscore™ test (OPKO Lab), offers various advantages over the more commonly used prostate specific antigen (PSA) blood test.

The new test improves on these common issues with the PSA blood test:

• Isn’t specific to cancer; detects a variety of prostate issues
• Doesn’t account for a natural tendency for PSA levels to rise with age

Posted by 4Kscore on Jan 5, 2016 12:00:00 PM

A blood test called the 4Kscore results in accurate detection of high-grade prostate cancer. In a prospective study of 1,012 men, this test more accurately predicted the presence of high-grade disease compared with a commonly used risk calculator in men with elevated prostate-specific antigen (PSA) levels.

The results from this study (Abstract 1) were presented by Sanoj Punnen, MD, a urologic oncologist at the University of Miami in Florida at the 2015 Genitourinary Cancers Symposium.

In this study, men scheduled for a prostate biopsy were enrolled, regardless of their PSA level or clinical findings, at 26 centers across the United States between October 2013 and April 2014. A total of 231 (23%) high-grade prostate cancers were detected. The 4Kscore showed a higher net benefit in comparison with the PCPTRC at all threshold possibilities for high-grade disease used in clinical practice.

Posted by 4Kscore on Dec 14, 2015 12:00:00 PM

ORLANDO—The 4Kscore, an algorithmic analysis of data from a blood test that combines four kallikrein assays with clinical information to identify the probability of high-grade prostate tumors, could dramatically reduce the number of unnecessary prostate biopsies, according to a multi-institutional prospective study (Abstract 1) presented during the 2015 Genitourinary Cancers Symposium.¹

Posted by 4Kscore on Dec 8, 2015 12:00:00 PM