Okpo Health - Früherkennung bei Prostatakrebs ?

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13.02.14 19:16
5

4301 Postings, 3572 Tage SpaetschichtOkpo Health - Früherkennung bei Prostatakrebs ?


OPKO gibt erfolgreichen Bestätigung der 4Kscore ? Algorithmin den Vereinigten Staaten

MIAMI, 13. Februar 2014 (BUSINESS

... (automatisch gekürzt) ...

http://www.opko.com
Moderation
Moderator: st
Zeitpunkt: 20.02.14 15:18
Aktion: Kürzung des Beitrages
Kommentar: Urheberrechtsverletzung, ggf. Link-Einfügen nutzen - Bitte nur kurz zitieren und Vollzitate vermeiden.

 

 

13.02.14 19:50

4301 Postings, 3572 Tage Spaetschicht4Kscore Prostate Cancer Test

4Kscore? is a next-generation prostate cancer test
Based on the following panel of kallikrein markers:

http://www.opko.com/products/...neration-prostate-cancer-diagnostics/


Total PSA
Free PSA
Intact PSA
Human Kallikrein 2 (HK2)
Enabling IP exclusively licensed from Arctic Partners (Finland)
In May 2012, OPKO licensed to International Health Technology, Ltd. (Cambridge, England), the right to offer 4Kscore?"s panel of novel kallikrein biomarkers in laboratory settings in the U.K., Ireland, Sweden, and Denmark.
In October 2012, IHT launched 4Kscore? in Europe, where the panel was recently featured in U.K. media.
OPKO is developing a point-of-care version of the 4Kscore? biomarker panel.
Predicts indolent versus aggressive prostate cancer
A panel combining our PSA test and our novel kallikrein markers could create a diagnostic test able to accurately predict prostate cancer-positive biopsies
Could lead to a 50% decrease in unnecessary prostate biopsies
750,000 unnecessary prostate biopsies are performed annually in the US
Kallikrein markers have been tested in over 10,000 patients:
Kallikrein panel predicts biopsy results in previously unscreened men with elevated PSA
"A Panel of Kallikrein Markers Can Reduce Unnecessary Biopsy for Prostate Cancer: Data from the European Randomized Study of Prostate Cancer Screening in Göteborg, Sweden"
Prior participation in PSA screening dramatically impacts biopsy predictions
"Impact of Recent Screening on Predicting the Outcome of Prostate Cancer Biopsy in Men with Elevated PSA: Data from the European Randomized Study of Prostate Cancer Screening in Gothenburg, Sweden"
Rotterdam replication of Gothenburg study
"Reducing Unnecessary Biopsy During Prostate Cancer Screening Using a Four-Kallikrein Panel: An Independent Replication"
Replication of Rotterdam study
"A Four-Kallikrein Panel Predicts Prostate Cancer in Men with Recent Screening: Data from the European Randomized Study of Screening for Prostate Cancer, Rotterdam"
External validation of Rotterdam study
"A Four-Kallikrein Panel for the Prediction of Repeat Prostate Biopsy: Data from the European Randomized Study of Prostate Cancer Screening in Rotterdam, Netherlands"
Biopsy outcomes predicted based on clinical work-up in addition to elevated PSA
"A Panel of Kallikrein Markers Can Predict Outcome of Prostate Biopsy Following Clinical Work-Up: An Independent Validation Study from the European Randomized Study of Prostate Cancer Screening, France"
Men predicted "low risk" by kallikrein panel unlikely to develop incurable prostate cancer
"A Panel of Kallikrein Marker Predicts Prostate Cancer in a Large, Population-Based Cohort Followed for 15 Years Without Screening"  

13.02.14 20:12

4301 Postings, 3572 Tage SpaetschichtMitral Herzklappe

Neovasc (Strategisches Investment von Opko!)

http://www.techsonian.com/...hnology-corporationotcmktsgnbt/12124562/

Opko Health, Inc. (OPK) told that Neovasc Inc. (NVC.V), a Vancouver-based company in which OPKO has made a strategic investment, reported that a first-in-human implantation of its Tiara? transcatheter mitral valve was successfully performed on January 30th by physicians at St. Paul?s Hospital in Vancouver, BC. The transapical procedure resulted in the removal of mitral regurgitation (MR) and significantly improved heart function in the patient, without the need for cardiac bypass support and with no procedural complications

First-in-human Tiara transcatheter mitral valve implantation successful

http://www.healio.com/cardiology/intervention/...lantation-successful

The first-in-human implantation of the Tiara transcatheter mitral valve was successfully performed in January at St. Paul?s Hospital in Vancouver, according to a press release issued by Neovasc Inc.

The patient was a 73-year-old man with severe functional mitral regurgitation who was considered a high-risk candidate for conventional valve repair or replacement surgery.

The transapical procedure was associated with elimination of mitral regurgitation and significantly improved heart function, without the need for cardiac bypass support or the incidence of significant paravalvular leak and procedural complications, according to the release.

?We are very pleased that this first implantation went so smoothly and that the patient?s outcome to date is so positive,? Anson Cheung, MD, professor of surgery and director of cardiac transplant at St. Paul?s Hospital, stated in the release. ?His recovery has been uneventful and we will continue to follow him closely over the coming months.? The implantation was performed by Cheung and John G. Webb, MD, director of interventional cardiology at St. Paul?s Hospital.

Tiara is a self-expanding bioprosthesis that replaces a native mitral valve without the need for CABG or cardiac bypass support.

?The ability to implant a prosthetic mitral heart valve using a transcatheter, minimally-invasive approach instead of conventional open-chest, open-heart surgery would provide a much-needed alternative for the many patients who are considered at high risk for conventional surgery,? Cheung stated in the release.  

13.02.14 20:35

4301 Postings, 3572 Tage SpaetschichtPhillip Frost MD

Ist im übrigen auch der CEO von
Teva Pharmaceutical Industries Ltd.

http://www.tevapharm.com/About/BoardOfDirectors/Pages/default.aspx

Officers and directors
Phillip Frost M.D. Chairman of the Board, Chief Executive Officer
                    § Age: 67
Bio & Compensation  - Reuters
Jane H. Hsiao Ph.D. Vice Chairman of the Board, Chief Technical Officer
Juan F. Rodriguez Chief Financial Officer, Senior Vice President
Steven D. Rubin Esq. Executive Vice President - Administration, Director
Thomas E. Beier Director
Robert A. Baron Independent Director
Richard A. Lerner M.D. Independent Director
John A. Paganelli Independent Director
Richard C. Pfenniger Jr. Independent Director  

14.02.14 16:29

4301 Postings, 3572 Tage SpaetschichtUnd wieder einmal

Opko Health CEO Phillip Md Et Al Frost Buys 21,800 Shares (OPK)


http://tickerreport.com/banking-finance/134377/...s-21800-shares-opk/  

20.02.14 19:13
1

4301 Postings, 3572 Tage SpaetschichtOpko Health

Opko Health Inc. (OPK) Completes Test On Cancer Diagnosis Tool

Opko Health Inc. (NYSE:OPK) has finished a recent round of tests for its 4Kscore diagnostic tool, used to test for prostate cancer, and Barrington Research analyst Charley R. Jones is convinced that this Opko Health Inc. (NYSE:OPK) could have multiple billion dollar products on its hands. Jones rates the company Outperform with an $11 twelve month price target (currently $8.5, down from $12.3 in October).

?We came away feeling very confident about each of Opko Health Inc. (NYSE:OPK)?s diagnostic programs. In addition, we came away knowing that OPK now has the right person running that division,? wrote Jones, after meeting with the head of Opko Health Inc. (NYSE:OPK)?s diagnostic division, David Okrongly.



http://www.valuewalk.com/2014/02/...es-test-on-cancer-diagnosis-tool/

Google übersetzer:

http://translate.google.de/...on-cancer-diagnosis-tool%2F&act=url  

20.02.14 23:14
1

287 Postings, 2518 Tage OXOXLÄUFT gut gen Nord

Ich denke jetzt kommen noch ein paar neue kursziele und dann
ist der knoten endlich geplatzt  

21.02.14 16:39

4301 Postings, 3572 Tage SpaetschichtOpko

Ja, Oxox bin im Moment ganz zufrieden. Ist auch heute wieder gut gelaufen und im Moment sind die 9$ geknackt ,woran die Aktie sich letzte Woche die Zähne ausgebissen hat.

Opko Health Inc. (OPK): Diagnostic Pipeline, Therapeutic Platforms Exciting

http://www.valuewalk.com/2014/02/...alth-inc-opk-diagnostic-pipeline/  

21.02.14 20:48

4301 Postings, 3572 Tage Spaetschichtzum Xten mal

Insider Buying: Phillip Md Et Al Frost Acquires 27,600 Shares of Opko Health Stock (OPK)


http://www.mideasttime.com/...-shares-of-opko-health-stock-opk/75173/  

27.02.14 20:51

4301 Postings, 3572 Tage SpaetschichtDie Quartalszahlen kommen am 17.März

28.02.14 16:14
1

287 Postings, 2518 Tage OXOX@spaet

28.02.14 20:03

4301 Postings, 3572 Tage SpaetschichtOxox

Ich danke Dir für den super Beitrag . Eine positive Medikamentenzulassung ist immer gut für den Kurs .

Das Volumen heute ist riesig!  Doppelt soviel wie Normal.
Vol / Avg. 6.40M/3.14M

Neulich hatte der Kurs ein Problem mit der 9 jetzt scheint er es mit der 10 zu haben

Grüße Spaet
 

28.02.14 20:09

4301 Postings, 3572 Tage SpaetschichtOpko stock rises on good news from FDA

Shares of Opko Health were up 7.2 percent on Friday morning after the Food and Drug Administration granted orphan drug designation to one of its key products.

http://www.bizjournals.com/southflorida/news/2014/...ws-from-fda.html

The Miami-based company (NYSE: OPK) is developing a longer-acting version of the blood clotting medication Factor Vlla to treat bleeding in patients with hemophilia. The drug was developed by Opko?s recently acquired Israeli subsidiary Prolor Biotech.
RELATED CONTENT: Opko Health closes acquisition of Israel?s Prolor Biotech
Opko said the worldwide market for the current version of this drug is $1.7 billion, but its version has shown the potential in clinical trials for substantial improvement in quality of life for patients, partly because it?s delivered by a single injection instead of multiple injections.
?We are pleased with the new orphan drug designation for Factor VIIa-CTP in the U.S., as it would allow Opko seven years of marketing exclusivity upon commercialization of the drug,? Opko Chairman and CEO Dr. Phillip Frost said in a news release. ?Expecting to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, we believe that we are in a unique position to be first to market with a longer acting Factor VIIa product.?  

04.03.14 18:43

4301 Postings, 3572 Tage SpaetschichtOpko

Opko Health (OPK) Announces Quarterly Earnings, Beats Estimates By $0.01 EPS

http://www.wkrb13.com/markets/272581/...-beats-estimates-by-0-01-eps/

Opko Health (NYSE:OPK) released its earnings data on Monday. The company reported ($0.04) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.05) by $0.01, Stock Ratings Network.com reports. The company had revenue of $20.70 million for the quarter, compared to the consensus estimate of $23.64 million. The company?s quarterly revenue was up 27.8% on a year-over-year basis.
A number of research firms have recently commented on OPK. Analysts at Barrington Research raised their price target on shares of Opko Health to $11.00 in a research note on Friday, December 20th. Analysts at Jefferies Group reiterated a ?buy? rating on shares of Opko Health in a research note on Wednesday, December 18th.
Shares of Opko Health (NYSE:OPK) traded down 1.26% on Monday, hitting $9.40. 2,801,036 shares of the company?s stock traded hands. Opko Health has a 1-year low of $6.14 and a 1-year high of $12.95. The stock has a 50-day moving average of $8.44 and a 200-day moving average of $9.23. The company?s market cap is $3.835 billion.  

06.03.14 18:22
1

287 Postings, 2518 Tage OXOXfrostie kauft wieder ein

10.03.14 18:15

4301 Postings, 3572 Tage SpaetschichtSony DADC

OPKO Diagnostics a division of OPKO Health Inc. (NYSE:OPK) and Sony DADC today announced the signing of a supply agreement for high volume production of a key component of the OPKO Sangia? microfluidic cassette. The Sangia cassettes are designed to perform quantitative immunoassays from a finger-stick blood sample on the Claros®1 in-office analyzer. The test results are reported in the physician?s office in 10 minutes. The first two OPKO Sangia tests are for total prostate specific antigen (Total PSA) and Total Testosterone.

http://www.pharmiweb.com/pressreleases/...p?ROW_ID=84235#.Ux3yIPl5Neo

Sony DADC BioSciences the leading OEM supplier of smart polymer-based consumables is using their ISO 13485 facility in Salzburg Austria to manufacture to OPKO Diagnostics? specifications.

?We are pleased to be partnered with Sony DADC a world leader in high precision consumable manufacturing for production of Sangia technology components? said David Okrongly president of OPKO Diagnostics. ?It is critical to us that Sony DADC also meets the regulatory demands of our in vitro diagnostic products and is manufacturing to the ISO 13485 quality standard.?

?We are delighted to have gained the trust of the team at OPKO Diagnostics. Based on our extensive experience in translating polymer science into robust manufacturing processes we look forward to supplying the Sangia microfluidic components to OPKO Diagnostics as they grow their global business footprint? said Dr. Chris Mauracher Senior Vice President of the BioSciences division of Sony DADC.

About Sony DADC

Building on Sony DADC?s experience in high-precision optical disk manufacturing Sony DADC?s BioSciences division partners with Life Sciences and Diagnostics companies enabling the industrial manufacturing of smart polymer parts. Sony DADC?s global set-up comprises production sites distribution hubs digital & service facilities in 19 countries worldwide including Japan the US and Europe. For more information please visit: http://biosciences.sonydadc.com/home/.

About OPKO Health

OPKO Health Inc. is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large rapidly growing markets by leveraging its discovery development and commercialization expertise and novel and proprietary technologies. For more information visit http://www.opko.com.

This press release contains "forward-looking statements" as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA) including statements regarding our product development efforts including whether our Sangia cassettes and Claros®1 in-office analyzer will perform as designed whether test results utilizing the cassettes and analyzer will be available in the physician?s office in 10 minutes and whether we will be able to successfully develop tests for Total PSA or Total Testosterone 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 Report on Form 10-K filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission as well as the risks inherent in funding developing and obtaining regulatory approvals of new commercially-viable and competitive products and treatments and risks that our diagnostic products under development including our Claros®1 diagnostic tests may fail may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications. In addition forward-looking statements may also be adversely affected by general market factors competitive product development product availability federal and state regulations and legislation the regulatory process for new products and indications manufacturing issues that may arise patent positions and litigation among other factors. 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.

Business Wire
http://www.businesswire.com/

More: http://www.pharmiweb.com/pressreleases/...#.Ux3yIPl5Neo#ixzz2va4ZRC26  

12.03.14 16:31

4301 Postings, 3572 Tage Spaetschicht1,987,500 Shares

hat MD Frost jetzt mittlerweile eingesammelt

Opko Health CEO Acquires $555,408 in Stock (OPK)

http://zolmax.com/investing/...o-acquires-555408-in-stock-opk/227505/

Opko Health (NYSE:OPK) CEO Phillip Md Et Al Frost acquired 60,900 shares of the stock on the open market in a transaction that occurred on Tuesday, March 11th. The stock was purchased at an average cost of $9.12 per share, for a total transaction of $555,408.00. Following the completion of the purchase, the chief executive officer now directly owns 1,987,500 shares of the company?s stock, valued at approximately $18,126,000. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at this link.
Shares of Opko Health (NYSE:OPK) traded down 0.10% on Wednesday, hitting $9.131.

141,824 shares of the company?s stock traded hands. Opko Health has a one year low of $6.14 and a one year high of $12.95. The stock?s 50-day moving average is $8.55 and its 200-day moving average is $9.29. The company?s market cap is $3.770 billion.
Opko Health (NYSE:OPK) last released its earnings data on Monday, March 3rd. The companyreported ($0.04) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.05) by $0.01. The company had revenue of $20.70 million for the quarter, compared to the consensus estimate of $23.64 million. The company?s revenue for the quarter was up 27.8% on a year-over-year basis. On average, analysts predict that Opko Health will post $-0.33 earnings per share for the current fiscal year.

A number of analysts have recently weighed in on OPK shares. Analysts at Barrington Research raised their price target on shares of Opko Health to $11.00 in a research note on Friday, December 20th. Analysts at Jefferies Group reiterated a ?buy? rating on shares of Opko Health in a research note on Wednesday, December 18th.
OPKO Health, Inc (NYSE:OPK), incorporated in October 1991, is a multi-national pharmaceutical and diagnostics company.
Get Analysts' Upgrades and Downgrades via Email - Stay on top of analysts' coverage with Analyst Ratings Network's FREE daily email newsletter that provides a concise list of analysts' upgrades and downgrades  

12.03.14 21:17

4301 Postings, 3572 Tage SpaetschichtOpko

sehr schön zu sehen , das der Widerstand bei 9 Dollar gehalten hat. Wurde auch schon von oben angetestet  
Angehängte Grafik:
chart_year_opkohealth.png (verkleinert auf 70%) vergrößern
chart_year_opkohealth.png

13.03.14 20:14

4301 Postings, 3572 Tage SpaetschichtOPKO Sangia


Orginal

http://www.pharmabiz.com/NewsDetails.aspx?aid=80881&sid=2

Google Übersetzung :

OPKO Diagnostics, ein Geschäftsbereich von OPKO Health, Inc. und Sony DADC haben eine Liefervereinbarung für die Massenproduktion einer Schlüsselkomponente des OPKO Sangia mikrofluidische Kassette unterzeichnet. Sangia Die Kassetten sind für quantitative Immunoassays von einem Finger-Stick Blut durchführen Probe auf dem Claros in-office-Analysator. Die Testergebnisse sind in der Praxis des Arztes in 10 Minuten berichtet. Die ersten beiden OPKO Sangia Tests sind für die gesamte Prostata-spezifischen Antigens (PSA gesamt) und Total Testosteron. Sony DADC BioSciences, der führende OEM-Lieferant von intelligenten Verbrauchsmaterialien auf Polymerbasis, ist mit ihren ISO 13485-Anlage in Salzburg, Österreich, zu fertigen OPKO Spezifikationen Diagnostics. "Wir freuen uns, mit Sony DADC, einem Weltmarktführer in der hohen Präzision Verbrauchs technologisch für die Produktion von Sangia Technologiekomponenten zusammen werden", sagte David Okrongly, Präsident der OPKO Diagnostics. "Es ist wichtig für uns, dass Sony DADC auch erfüllt die aufsichtsrechtlichen Anforderungen unserer in-vitro-diagnostische Produkte, und ist die Herstellung der ISO-13485-Qualitätsstandard." "Wir freuen uns, das Vertrauen des Teams bei OPKO Diagnostics gewonnen zu haben. Basierend auf unseren umfangreiche Erfahrung in der Übersetzung in die Polymerwissenschaft robuste Fertigungsprozesse, freuen wir uns auf die Versorgung der Sangia mikrofluidischen Komponenten OPKO Diagnose, wie sie ihre globale Business-Fußabdruck wachsen ", sagte Dr. Chris Mauracher, Senior Vice President der Biowissenschaften Abteilung von Sony DADC. Aufbauend auf Sony DADC Erfahrung in der hochpräzisen Herstellung optischer Disks. Sony DADC BioSciences Division Partner Life Sciences und Diagnostik-Unternehmen ermöglicht die industrielle Fertigung von Smart-Kunststoffteilen OPKO Health, Inc. ist ein multinationales biopharmazeutisches und Diagnostik-Unternehmen, die zu etablieren sucht branchenführende Positionen in großen, schnell wachsenden Märkten durch den Einsatz ihrer Entdeckung, Entwicklung und Vermarktung Know-how und neue und proprietäre Technologien  

13.03.14 20:15

4301 Postings, 3572 Tage SpaetschichtDer tägliche Kauf ;-)

13.03.14 23:00

4301 Postings, 3572 Tage SpaetschichtWenn

ich das alles so richtig verstanden habe geht hier mit Hilfe der Sony DADC die
OPKO Sangia Tests in Massenproduktion  

14.03.14 17:22

4301 Postings, 3572 Tage SpaetschichtOutperform

von Oppenheimer
http://www.wkrb13.com/markets/279179/...-coverage-on-opko-health-opk/
Oppenheimer began coverage on shares of Opko Health (NYSE:OPK) in a research note issued to investors on Thursday, TheFlyOnTheWall.com reports. The firm issued an outperform rating and a $13.00 price target on the stock.
Several other analysts have also recently commented on the stock. Analysts at Barrington Research raised their price target on shares of Opko Health to $11.00 in a research note on Friday, December 20th. Analysts at Jefferies Group reiterated a buy rating on shares of Opko Health in a research note on Wednesday, December 18th. One investment analyst has rated the stock with a hold rating and three have assigned a buy rating to the company. Opko Health presently has an average rating of Buy and a consensus price target of $12.83.
Shares of Opko Health (NYSE:OPK) traded up 4.40% during mid-day trading on Thursday, hitting $9.73. The stock had a trading volume of 1,899,055 shares. Opko Health has a 52-week low of $6.14 and a 52-week high of $12.95. The stock has a 50-day moving average of $8.57 and a 200-day moving average of $9.30. The company?s market cap is $4.018 billion.

Opko Health (NYSE:OPK) last released its earnings data on Monday, March 3rd. The company reported ($0.04) EPS for the quarter, beating the Thomson Reuters consensus estimate of ($0.05) by $0.01. The company had revenue of $20.70 million for the quarter, compared to the consensus estimate of $23.64 million. The company?s quarterly revenue was up 27.8% on a year-over-year basis. On average, analysts predict that Opko Health will post $-0.33 earnings per share for the current fiscal year.
In other Opko Health news, CEO Phillip Md Et Al Frost purchased 6,000 shares of the company?s stock on the open market in a transaction dated Wednesday, March 12th. The stock was purchased at an average cost of $9.25 per share, for a total transaction of $55,500.00. Following the purchase, the chief executive officer now directly owns 1,987,500 shares in the company, valued at approximately $18,384,375. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available at this link.
OPKO Health, Inc (NYSE:OPK), incorporated in October 1991, is a multi-national pharmaceutical and diagnostics company.
To view Oppenheimer?s full report, visit Oppenheimer?s official website.  

27.03.14 12:38

4301 Postings, 3572 Tage SpaetschichtAmerican Urological Association (AUA)

akzeptiert den  4Kscore Test



Accepts 4Kscore Test Clinical Study for Plenary Presentation at 2014 Annual Meeting

Read more here: http://www.heraldonline.com/2014/03/25/5804282/.../385/#storylink=cpy


Google übersetzer:

http://translate.google.de/...Fsp%3D%2F100%2F773%2F385%2F&act=url

MIAMI ? OPKO Health, Inc. (NYSE:OPK) today announced that the American Urological Association (AUA) has accepted ?The 4KscoreTM Test as a Predictor of High-Grade Prostate Cancer on Biopsy? as a Late-Breaking Abstract for presentation in Plenary I on Sunday May 18, 2014 at the AUA Annual meeting in Orlando, FL.

The data accepted are from a prospective, blinded study conducted at 26 urology clinics across the United States from October 2013 to January 2014. The data confirm the accuracy of the 4KscoreTMalgorithm in a United States population of men referred for prostate biopsy. The 4KscoreTM algorithm, which is based on the values of four different kallikrein blood tests (total PSA, free PSA, intact PSA and hK2) plus age, DRE and prior biopsy status, was originally studied in multiple European cohorts involving over 10,000 patients.

?These are challenging times in urology as we are seeing a decline in men screened for prostate cancer with PSA, yet we know that mortality from prostate cancer has steadily declined since the introduction of PSA screening,? said Dr. Stephen M. Zappala, MD FACS of Andover Urology. ?The 4KscoreTM test offers new information on the probability of having a Gleason Score ≥ 7 cancer prior to undergoing a prostate biopsy. This is important, because we know that besides the potential side effects of biopsy such as bleeding and infection, up to 80% of prostate biopsies will either be negative for prostate cancer or will indicate a low grade disease that may be better monitored than treated. The 4KscoreTM test will offer both the Urologist and patient new information for the shared decision-making discussion about whether or not to have a prostate biopsy.?

?Acceptance as a late-breaking abstract highlights both the quality of the clinical data for the 4KscoreTM test and the urgent need to have a solution for more effective biomarker-based tests for managing prostate cancer risk and the disease itself,? said David Okrongly, President of OPKO Diagnostics. ?We are looking forward to presenting the full US clinical trial data at the AUA meeting in May.?

?The results of the US clinical study are now complete and we are pleased to also announce that we are on track for launch of the 4Kscore Test on March 31, 2014,? said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.

About the 4Kscore? Test

The 4Kscore? is a convenient blood test that measures the serum levels of four different prostate-derived kallikrein proteins: total PSA, free PSA, intact PSA and hK2. Levels of these biomarkers are combined with a patient's age and digital rectal exam (DRE) status using a proprietary algorithm to calculate the probability of a finding of aggressive prostate cancer. The 4Kscore? test is based on over a decade of research of the four kallikrein panel of biomarkers conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients. The information provided by the 4Kscore? test can help facilitate the shared decision-making process between urologist and patient in determining the advisability of a prostate biopsy.

About Prostate Cancer

In 2013, over 238,000 new cases of prostate cancer will be identified and 29,720 men will die from the disease, according to estimates released by the National Cancer Institute, making it the second most deadly cancer in U.S. men. Prostate cancer is usually first detected by elevations in serum PSA. However, PSA level is often high for reasons unrelated to prostate cancer and, since an elevated PSA level often leads to biopsy, 75% of all prostate biopsies performed are either negative or indicate a low likelihood of aggressive cancer.

ABOUT OPKO HEALTH, INC.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.

SAFE HARBOR STATEMENT

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 benefits of the 4Kscore?, whether OPKO's multi-center validation study will support CLIA validation and reimbursement, whether the 4Kscore? will be an important tool in the fight against prostate cancer and the prevention of unnecessary biopsies, expectations regarding the success of the product, whether it will provide the probability of having a Gleason Score ≥7 prostate cancer prior to undergoing a prostate biopsy, whether it will offer new information for better shared decision-making between a Urologist and patient about whether or not to have a prostate biopsy, whether we will able to present the full clinical data at the AUA meeting, whether OPKO will be able to successfully launch and commercialize the 4Kscore? and the expected launch date for the 4Kscore?, the market for and expected sales of 4Kscore?, whether the test will address a significant unmet medical need for more effective biomarker-based tests for managing prostate cancer risk and the disease itself, 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 filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. 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.

Read more here: http://www.heraldonline.com/2014/03/25/5804282/.../385/#storylink=cpy  

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