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.
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.
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