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(Address of principal executive offices) +1 (646)650–1351 Trading Symbol(s)Name of Each Exchange on WhichRegistered Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.Large accelerated filer☐Accelerated filer☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ TABLE OF CONTENTSPART IFINANCIAL INFORMATION CONTROLS AND PROCEDURES LEGAL PROCEEDINGS Item 1A.RISK FACTORS UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the PrivateSecurities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this Report or incorporated statements contained in this Report, and the information and documents incorporated by reference within this Report, relate to, amongother things, our predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy, including regulatory approvals, commercialization and market acceptance; statementsconcerning industry trends and industry size; statements regarding anticipated demand for our products and market opportunity, orthe products of our competitors; statements relating to manufacturing forecasts, and the potential impact of our relationships withcontract manufacturers, original equipment manufacturers and distributors on our business; assumptions regarding the future costand potential benefits of our research and development efforts; the effect of critical accounting policies; forecasts of our liquidity and documents incorporated by reference within this Report.We have based our forward-looking statements on our current assumptions, expectations and projections about trends affecting ourbusiness and industry and other future events. Although we do not make forward-looking statements unless we believe we have areasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial known andunknown risks and uncertainties that could cause our future business, financial condition, results of operations or performance, todiffer materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report. Some significant factors that may impact our estimates and forward-looking statements include, but are not limited to: Our inability to generate any significant revenues or achieve profitability;Our need to raise additional capital in the future; Our expansion of our product development and sales and marketing capabilities could give rise to difficulties in managingour growth;Our dependence on third-party distributors;Our limited experience with sales and marketing;The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from ourauditors; The highly competitive and rapidly changing nature of the diagnostics market;Protection of our patents, intellectual property and trade secrets;Our reliance on third parties to manufacture and supply our intended products, and such manufacturers’ dependence onthird-party suppliers;The material weaknesses in our internal control over financial reporting that we have identified;Pressures related to macroeconomic and geopolitical conditions; andOther risks identified elsewhere in this Report, as wellas in our other filings with the Securities and Exchange Commission (the “SEC”). do not currently view as material to our business. For these reasons, readers are cautioned not to place undue reliance on anyforward-looking statements.You should read this Report in its entirety, including the documents that we file as exhibits to this Report and the documents weincorporate by reference into this Report, with the understanding that our future results may be materially different from what we Condensed Consolidated Balance Sheets Condensed Consolidated Statements of Stockholders’ DeficitCondensed Consolidated Statements of Cash FlowsNotes to the Condensed Consolidated Financial Statements4 Note 1 - Basis of Presentation andSummary of Significant Accounting Policies (continued)Fair Value MeasurementsPursuant to ASC 820, “Fair Value Measurements and Disclosures,”an entity is required to maximize the use of observable inputs andminimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.