Friday, February 01, 2019 8:57:52 AM
MIAMI, Feb. 01, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer. The product is indicated to quantitatively measure total PSA in whole blood from a fingerstick of blood collected by a healthcare professional and is used in conjunction with a digital rectal exam as an aid in the detection of prostate cancer in men aged 50 years and older.
There are 25 million PSA tests performed in the United States annually. The Company plans to expand the number of assays on the Claros 1 technology platform through future submissions to the FDA, including a planned submission for a testosterone test later this year.
“We are pleased that the FDA has approved our point-of care Sangia PSA Test with the Claros 1 Analyzer. This approval contributes to our growing urology franchise and affords us the momentum to expand the test menu on the Claros 1 technology platform in the future,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO Health. “We believe that a PSA test that provides results in the physician’s office will significantly benefit the diagnostic paradigm for prostate cancer,” added Dr. Frost.
The Claros 1 Analyzer is a novel diagnostic instrument system that can provide rapid, quantitative test results in 10 minutes – right in the physician’s office. The Claros 1 incorporates cutting edge microfluidic technology in a credit card sized disposable test cassette. No external reagents or blood sample preparations are required. The microfluidic assay cassette is inserted into a desktop size Claros 1 Analyzer. Data supporting the approval of Sangia PSA test include field use studies at multiple clinics to demonstrate accuracy and sensitivity comparable to that obtained with FDA approved large analyzers used by central reference laboratories using large blood samples drawn from veins.
Recent OPK News
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/20/2024 06:56:10 PM
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 09/18/2024 08:13:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 09:00:42 PM
- Labcorp Completes Acquisition of Select Assets of BioReference Health's Diagnostics Business from OPKO Health • PR Newswire (US) • 09/16/2024 11:30:00 AM
- Form DEFR14A - Revised definitive proxy soliciting materials • Edgar (US Regulatory) • 08/30/2024 09:01:33 PM
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 08/23/2024 09:33:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:23:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 08:50:25 PM
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 08/12/2024 10:27:05 PM
- Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates • GlobeNewswire Inc. • 08/09/2024 08:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 09:39:52 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/07/2024 08:12:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 08:07:42 PM
- OPKO Health Reports Second Quarter 2024 Business Highlights and Financial Results • GlobeNewswire Inc. • 08/07/2024 08:06:35 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 08:21:51 PM
- OPKO Health to Report Second Quarter 2024 Financial Results on August 7, 2024 • GlobeNewswire Inc. • 08/01/2024 08:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/31/2024 09:03:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:49:22 PM
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 07/26/2024 11:43:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:18:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:15:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:11:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:08:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 11:05:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/23/2024 09:16:09 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM