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.

For Prostate Cancer Awareness Month, Hattiesburg American News spoke with our client Hattiesburg Clinic Urology about the 4Kscore, a revolutionary test that predicts a man’s risk of developing aggressive prostate cancer. The test assists physicians, urologists, and nurse practitioners in making better-informed patient care decisions. Please read the full article below and see the original post on Hattiesburg American News.

September is Prostate Cancer Awareness Month

“Approximately 1 in 7 men will be diagnosed with prostate cancer during his lifetime, according to the American Cancer Society. In 2016, specifically, the ACS estimates 180,890 new cases of prostate cancer will be diagnosed, with more than 26,000 of those resulting in death.

The news of the medical advancements associated with the 4Kscore test is sparking conversation around the globe. In an effort to speak with medical professionals directly and answer questions, the 4Kscore team has hit the road.

We have made connections and generated awareness at many American Urology Association (AUA) annual meetings including the North Central Section AUA, South Central Section AUA, New England Section AUA, and Northeastern Section AUA. Recently, we had great conversations at the Prostate Cancer Academy in Colorado, as well as the American Association of Family Practitioners (AAFP) 2016 Family Medicine Experience (FMX) in Orlando, Florida.

“The goal of diagnosing and treating prostate cancer is diagnosing it early on when it’s confined to the prostate”

NEW YORK, NY–(Marketwired – Sep 7, 2016) – During their lifetime approximately one in seven men will be diagnosed with prostate cancer, the second most common cancer among men in the U.S. The odds increase for African Americans and double for those with a family history of the disease.

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.

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.

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.

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.

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

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.