Item 5.07 Submission of Matters to a Vote of Security Holders.
On
As of
Proposal 1: Election of Directors
The Company's stockholders elected the persons listed below to serve until the Company's 2024 Annual Meeting of Stockholders. The final voting results are as follows:
Name Votes For Votes Withheld Broker Non-Votes Marsha A. Chandler 3,455,399 520,626 2,783,615 Ivor Royston, M.D. 3,451,384 524,641 2,783,615
Proposal 2: Ratification of the Selection of Independent Registered Public Accounting Firm
The Company's stockholders ratified the selection by the
Votes For 6,218,043 Votes Against 292,764 Abstentions 248,833 Broker Non-Votes 0
Proposal 3: Approval of Amendment to Amended and Restated 2013 Equity Incentive Plan, as Amended
The Company's stockholders approved an amendment to the Company's Amended and Restated 2013 Equity Incentive Plan, as amended, to, among other things, increase the number of shares authorized for issuance under such plan by 1,300,000 shares. The final voting results are as follows:
Votes For 2,607,362 Votes Against 1,182,502 Abstentions 186,160 Broker Non-Votes 2,783,615
Proposal 4: Approval, on an Advisory Basis, of the Compensation of the Company's Named Executive Officers
The Company's stockholders approved, on an advisory basis, the compensation of the Company's named executive officers, as disclosed in the Company's definitive proxy statement for the Annual Meeting. The final voting results are as follows:
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Votes For 2,732,629 Votes Against 1,072,271 Abstentions 171,124 Broker Non-Votes 2,783,615
Proposal 5: Authorization to adjourn the Annual Meeting
The Company's stockholders approved the authorization to adjourn the Annual Meeting, if necessary, to solicit additional proxies if there were not sufficient votes in favor of Proposal 3. The final voting results are as follows:
Votes For 2,860,584 Votes Against 858,293 Abstentions 257,147 Broker Non-Votes 2,783,615 Item 8.01 Other Events.
On
About 20% of breast cancers are HER2-positive, with metastatic cancers more likely to be HER2-positive and approximately 20% of HER2-positive patients experiencing recurrence each year. Given the efficacy of various anti-HER2 therapies, testing for HER2 is one of the most important sources of information used by oncologists in making treatment decisions for patients with breast cancer. As a result, guidelines for breast cancer recommend that all patients with new primary or newly metastatic breast cancer be tested for HER2. Traditionally, testing has been performed using tissue. However, adequate tissue from the original biopsy may not be available, and additional invasive biopsy procedures are often impractical and associated with complications.
The MolDx program was developed by CMS to identify and establish coverage and reimbursement for molecular diagnostic tests. To receive a favorable MolDx coverage determination, assays must demonstrate clinical utility, fulfill the CMS reasonable and necessary criteria, and meet analytical and clinical validity standards. The LCD, which includes other cancer biomarkers in addition to HER2, is posted on the CMS website.
The Company's combined cell-based and cell-free liquid biopsy tests assess
actionable cancer biomarkers from a patient's blood and, uniquely, from
cerebrospinal fluid ("CSF") as well. Following the full commercial launch of its
CSF assay, CNSide, the Company submitted an initial application for Breakthrough
Device Designation to the
Forward-Looking Statements
This report contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to be correct. To the extent that statements in this report are not strictly historical, including, without limitation, statements regarding the benefits that can be provided by the Company's Target Selector assay and its ability to receive FDA breakthrough device designation for CNSide, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation
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Reform Act of 1995. The reader is cautioned not to put undue reliance on these
forward-looking statements, as these statements are subject to numerous risks
and uncertainties, including the risk that the prevalence of HER2 in breast
cancer patients will decline in the future to a point where guidelines for
breast cancer may no longer recommend that all patients with new primary or
newly metastatic breast cancer be tested for HER2, which in turn would impact
demand for the Company's Target Selector assay and could also impact its LCD,
the risk that the Company may not receive breakthrough device designation by the
FDA for CNSide, and even if it does, such designation may not lead to a faster
development, regulatory review or clearance process, and it may not increase the
likelihood that the assay will receive marketing authorization from the FDA, and
the risk that our products and services may not perform as expected. These and
other risks are described in greater detail under the "Risk Factors" heading of
the Company's Quarterly Report on Form 10-Q for the quarter ended
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