4Kscore featured on UroToday: AUA 2017

AUA 2017 just wrapped up in Boston, MA. On Sunday May, 14, Dr. Karim Marzouk and colleagues from Memorial Sloan Kettering Cancer Center presented a poster titled “Combining 4Kscore and MRI for Prostate Biopsy Decision Making”. The session highlighted the findings from the recently published PROMIS MRI trial, utilizing the multiparameteric MRI (mpMRI) as a follow-up test to the 4Kscore. Please read the full article about the session and study below and see the original post on UroToday.

 

AUA 2017: Combining 4KScore and MRI for Prostate Biopsy Decision Making

 

Boston, MA (UroToday.com) At today’s 2017 AUA Annual meeting prostate cancer diagnosis and screening podium session, Dr. Marzouk and colleagues presented their work from Memorial Sloan Kettering Cancer Center assessing the utility of multiparameteric MRI (mpMRI) as a follow-up test to the 4Kscore. As the recently published PROMIS MRI trial demonstrated, 11% of men with a normal MRI will have high-grade disease [1]. Since we have many biomarkers, including imaging modalities, available to clinicians in the pre-biopsy setting, studies delineating appropriate patient specific sequences of tests are important.

 

In this study, the 4Kscore results from the US prospective validation study were combined with mpMRI data available from the PROMIS study. The author used likelihood ratios for MRI detecting high grade disease from PROMIS (positive and negative likelihood ratio of 1.58 and 0.17, respectively) and applied these ratios to probabilities of 4Kscores. Four unique populations were identified based on a threshold for biopsy of 7.5% risk of high grade disease: (i) men with very low 4Kscore for whom risk would not be <7.5% even with positive MRI, (ii) men with 4Kscores <7.5% whose risk would be ≥7.5% if MRI were positive, (iii) men with 4Kscores ≥7.5% whose risk would be <7.5% if MRI were negative, and (iv) men with high 4Kscores whose risk would remain ≥7.5% even if MRI were negative. In the 4Kscore validation study, 1012 men underwent prostate biopsy 23% were diagnosed with ≥Gleason 7 disease. The range of 4Kscores that could be influenced by the results of MRI included 26% of the population with risk <5% (group 1), 10% with risk 5-7.4% (group 2), 45% with risk 7.5-32% (group 3), and 21% with risk > 32% (group 4). Importantly, the net benefit of using 4Kscores alone was 17.7%, mp-MRI 17.6%, and combined strategies was 18.2%.

 

In summary, this is an elegant study combining imaging and biomarkers to further delineate who should undergo a biopsy. Using mpMRI in the setting of low-intermediate 4Kscores results in a biopsy strategy with higher net benefit compared to using either modality alone.

 

See Original article at UroToday

OPKO Announces Multiple Presentations at the 112th American Urological Association Annual Meeting

Highlights 4Kscore’s ability to predict aggressive prostate cancer

Showcasing 4Kscore and Claros 1 Point-of-Care System at Exhibit Booth #904

MIAMI, May 15, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (Nasdaq:OPK) announces that multiple podium and poster presentations highlighting the Company’s 4Kscore test will be presented at the 112th American Urological Association (AUA) Annual Meeting taking place from May 12-16, 2017 in Boston.

The following podium and poster presentations highlighting the 4Kscore test will take place in Room 162 of the Boston Convention and Exhibition Center:

Title: The 4Kscore Test Accurately Predicts Aggressive Prostate Cancer in Men of all Ages and Race”
Poster: Poster presentation PD07-01
Date/Time: May 12, 2017 at 9:30 am ET
Title: Combining 4KScore and MRI for prostate biopsy decision making”
Poster: Poster presentation PD40-08
Date/Time: May 14, 2017 at 9:30 am ET
Title: A four-kallikrein panel in predicting high-grade prostate cancer on biopsy: an independent replication from the Finnish section of the European Randomized Study of Screening for Prostate Cancer”
Poster: Poster presentation PD40-06
Date/Time: May 14, 2017 at 10:20 am ET
Title: Does 4K and/or Michigan Prostate Score Change Cancer Detection Rates in Multi-Parametric MRI discovered PIRADS 3 or Lower Lesions?”
Poster: Poster presentation PD65-09
Date/Time: May 16, 2017 at 8:20 am ET
Title: An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer”
Podium: Podium presentation PD71-04
Date/Time: May 16, 2017 at 10:00 am ET

To learn more about the Company’s 4Kscore test and Claros 1 Point-of-Care system, visit the OPKO Health Booth #904 in the Exhibit Hall.

About the 4Kscore™ Test
The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient’s age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines.

About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, an androgen receptor modulator for androgen deficiency indications, OPK88002, a NK-1 inhibitor to treat pruritus (severe itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome. In addition, the Company is advancing its CTP technology, which includes a long-acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long-acting Factor VIIa drug for hemophilia in phase 2a.  OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding expected clinical utility and financial performance and expectations regarding our 4Kscore test  and the expected benefits of our 4Kscore test, whether clinical trial results are indicative of the 4Kscore test’s ability to predict aggressive prostate cancer,  as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

We Hope to See You at AUA2017!

The American Urological Association’s 2017 Annual Meeting is just around the corner. This annual event provides the ideal platform for thought leaders in the field to explore the latest advances in urologic medicine. Attendees from around the globe will gather in Boston, Massachusetts, May 12 – 16, for the 112th AUA Annual Meeting. Last year’s meeting attracted more than 16,000 attendees, from 111 countries, a testament to its significance in the international urologic medical community.

Connect with GenPath at Booth 904

At GenPath, we are gearing up for AUA2017 and we hope to see you there! Be sure to visit our booth to learn more about the larger impact of the 4Kscore. Connect with our team and get answers to your questions.

Join us throughout the week for talks and symposiums including:

Advancements in Prostate Cancer Diagnostics: Genetic Testing & 4Kscore

Attendees will learn about an exciting development from our genetics division, GeneDx; a new panel that tests for hereditary prostate cancer genes to help patients understand their genetic risk for the disease and clinicians make management decisions. We will also explore how the 4Kscore and genetic testing can fit into the urology practice.

  • Speakers:
    • Benjamin D. Solomon, MD, FACMG – Managing Director, GeneDx
    • Sanoj Punnen, MD, MAS – Assistant Professor of Urologic Oncology, University of Miami, Miller School of Medicine and Sylvester Comprehensive Cancer Center
    • Mitchell Steiner, MD, FACS – Moderator
  • Date: Sunday, May 14, 2017
  • Time: 10:00AM – 11:00AM
  • Location: ICU Theatre – Booth 1354

Pre-register today!

4Kscore: An Actionable Biomarker in an Era of Accountable Care

Attendees will learn more about 4Kscore and how their patients will benefit from the test.

  • Speaker: Dr. Steve Zappala
  • Dates/Times: Saturday 5/13 and Monday 5/15 at 10:30AM
  • Location: Booth 904

GeneDx: Supporting Urologists in the Evaluation of Hereditary Prostate Cancer through Genetic Testing

Attendees will discover how genetic testing can easily fit into a Urologist’s practice and inform medical management.

  • Speaker: Lance Grau (Genetic Counselor for GeneDx)
  • Dates/Times: Saturday 5/13, Sunday 5/14, and Monday 5/15 at 12:30PM
  • Location: Booth 904

The Role of 4Kscore and Multiparametric MRI for Diagnosing Aggressive Prostate Cancer

Attendees will learn how Urologists are combining the 4Kscore and MRI in the evaluation of men suspected of having aggressive prostate cancer.

  • Speaker: Dr. Jay Newmark
  • Dates/Times: Saturday 5/13, Sunday 5/14, and Monday 5/15 at 2:30PM
  • Location: Booth 904

Discover More About the 4Kscore at AUA2017

Not only will we be sponsoring a booth and hosting a number of talks, the 4Kscore will also be featured in AUA Curriculum by independent physicians. Do not miss your chance to learn more about the vital role the 4Kscore is playing in modern urologic medicine.

The 4Kscore Test Accurately Predicts Aggressive Prostate Cancer in Men of all Ages and Race

  • Date: Friday, May 12, 2017
  • Time: 9:30AM

A four-kallikrein panel in predicting high-grade prostate cancer on biopsy: an independent replication from the Finnish section of the European Randomized Study of Screening for Prostate Cancer

  • Date: Sunday, May 14, 2017
  • Time: 10:20AM

Combining 4Kscore and MRI for Prostate Biopsy Decision Making

  • Date: Sunday, May 14, 2017
  • Time: 10:40AM

Does 4K and/or Michigan Prostate Score Change Cancer Detection Rates in Multi-Parametric MRI discovered PIRADS 3 or Lower Lesions

  • Date: Tuesday, May 16, 2017
  • Time: 8:20AM

An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer

  • Date: Tuesday, May 16, 2017
  • Time: 10:00AM

Ready to Learn More About the 4Kscore?

Will you be attending AUA2017? If so, we encourage you to visit our booth and to take in the symposiums and talks outlined above. If you will not be attending this year’s meeting, be sure to connect with us on Facebook, Twitter, Google+ and LinkedIn. Stay in-the-know about the exciting advancements in urological medicine that will be announced at this year’s meeting. Join in the conversation!

 

GenPath is a division of BioReference Laboratories, Inc.