April 22, 2020: TearLab Corporation announced that the U.S.FDA has accepted the resubmission of its 510(k) application for the potential clearance of its TearLab Discovery™ MMP-9 Test, the Company’s next-generation in-vitro diagnostic testing system.
The submission covers the TearLab Discovery™ Platform and its single-use, disposable Test Card measuring the inflammatory biomarker, matrix metalloproteinase 9 (MMP-9). TearLab Discovery™ will also be capable of performing the Company’s current FDA cleared tear osmolarity test.
Seph Jensen, TearLab’s Chief Executive Officer commented, “We are excited to complete the resubmission of our 510(k) application for the TearLab Discovery™ platform. We believe this next generation platform, which utilizes comprehensive in vitro diagnostic testing, will offer eye care professionals greater precision and efficiency to aid in the diagnosis of ophthalmic conditions.
We look forward to continued communication and partnering with the agency through the remainder of the review process.”
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively testing for disease bio-markers in tears at the point-of-care.
The TearLab Osmolarity Test, to aid in the diagnosis Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. TearLab Corporation’s common shares trade on the OTCQB Market under the symbol ‘TEAR’.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include, among others, the expected functionality and benefits of the TearLab Discovery™ platform. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements.
Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2019. We do not undertake to update any forward-looking statements except as required by law.”
https://www.tearlab.com/investors/press-releases.htm
