UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

FORM SD

Specialized Disclosure Report

ACCELERATE DIAGNOSTICS, INC.

(Exact name of registrant as specified in its charter)

Accelerate Diagnostics, Inc.

3950 South Country Club Road, Suite 470

Tucson, Arizona 85714

(Address of principal executive offices) (Zip Code)

Steve Reichling

(520) 365-3113

(Name and telephone number, including area code, of the person to contact in connection with this report)

Check the appropriate box to indicate the rule pursuant to which this form is being filed, and provide the period to which the information in this form applies:

SECTION 1. CONFLICT MINERALS DISCLOSURE

Item 1.01. Conflict Minerals Disclosure and Report

Pursuant to Rule 13p-1 and Section 13(p) of the Securities Exchange Act of 1934, as amended, which implements Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Conflict Regulations”), Accelerate Diagnostics, Inc. (the “Company”) is required to make certain inquiries and perform certain due diligence with respect to any “conflict minerals” (as defined by paragraph (d)(3) of Item 1.01 of Form SD) that are necessary to the functionality or production of a product manufactured (or contracted to be manufactured) by the Company or any of its subsidiaries.

Conflict minerals are necessary to the functionality of certain of the Company’s products. As required in the Conflict Regulations, the Company has conducted a reasonable country of origin inquiry (“RCOI”) designed to determine whether any of the conflict minerals originated in the Democratic Republic of the Congo or an adjoining country or are from recycled or scrap sources. Based on its RCOI, the Company was unable to reasonably conclude that all of the conflict minerals contained in its products did not originate in the Democratic Republic of the Congo or an adjoining country or come from recycled or scrap sources. Therefore, the Company is required to exercise due diligence on the source and chain of custody of its conflict minerals in accordance with the Conflict Regulations and Form SD.

Conflict Minerals Disclosure

The Company has filed a Conflict Minerals Report, which is attached hereto as Exhibit 1.01 and is incorporated herein by reference. Such report is also publicly available on the Company’s website at the following web address: http://ir.axdx.com/governance-documents.

Item 1.02. Exhibit

Information concerning conflict minerals required by the Conflict Regulations is included in Exhibit 1.01 to this Specialized Disclosure Report on Form SD.

SECTION 2. EXHIBITS

Item 2.01. Exhibits

SIGNATURES 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the duly authorized undersigned.

 EXHIBIT INDEX

Exhibit 1.01

Accelerate Diagnostics, Inc.

Conflict Minerals Report

For The Year Ended December 31, 2019

This Conflict Minerals Report for the year ended December 31, 2019 is submitted by Accelerate Diagnostics, Inc. (“Accelerate” or the “Company”) as required by Section 13(p) of, and Rule 13p-1 under, the Securities Exchange Act of 1934, as amended (the “Conflict Regulations”). Pursuant to the April 29, 2014 “Statement on the Effect of the Recent Court of Appeals Decision on the Conflict Minerals Rule” issued by Keith F. Higgins, Director, SEC Division of Corporation Finance, the Company is not required to describe its products as “DRC Conflict Undeterminable” or “not found to be DRC Conflict Free.” In addition, the Company is not required to obtain, and has not obtained, an independent private sector audit of this Conflict Minerals Report.

This report has been prepared by management and supply chain personnel of the Company. The information includes the activities of all subsidiaries that are included in the Company’s consolidated financial statements.

Accelerate is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistance and hospital acquired infections. Accelerate’s first diagnostic instrument, the Accelerate Pheno® system, is designed to support the delivery of identification and susceptibility testing across several relevant sample types. Accelerate maintains its principal executive office at 3950 South Country Club, Tucson, Arizona, 85714.

During 2019, the Company manufactured and sold two categories of products: (1) its Accelerate Pheno system instrument and (2) Accelerate PhenoTest® BC Kit consumables. The Accelerate Pheno system is the Company’s rapid diagnostic platform. It features walk-away automation and consists of a fixed instrument and proprietary single-use test kit. The instrument consists of module(s) connected to a single analysis computer, which allows hospitals to acquire various numbers of modules to address their particular test volume. To run a patient sample on the Accelerate Pheno system, a laboratory technician would pipette the patient sample into the Company’s system, insert the Accelerate PhenoTest BC Kit, and initiate the run. Following these simple steps, rapid diagnostic results are delivered for clinical action.

The Company conducted an analysis of its products and determined that tin, tungsten, tantalum and gold can be found in its Accelerate Pheno system instrument and that gold and tin can be found in its Accelerate PhenoTest BC Kit consumables.

Based on the Company’s reasonable country of origin inquiry (“RCOI”), the Company was unable to reasonably conclude that all of its conflict minerals did not originate in the Democratic Republic of the Congo or adjoining countries (“Covered Countries”) or come from recycled or scrap sources. Conflict minerals are obtained from sources worldwide, and the Company does not desire to eliminate those originating in the Covered Countries. Although, the Company is committed to conflict free sourcing of minerals from its supply chain, the Company also recognizes the importance of supporting responsible mineral sourcing from the Covered Countries so as not to negatively impact the economies of those countries.

The Company first began to commercialize products containing conflict minerals in 2017, and, in accordance with the Conflict Regulations, the Company is continuing its diligence on the source and chain of custody of its conflict minerals using the Organisation for Economic Co-operation and Development (“OECD”) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (Third Edition, OECD 2016) and the related Supplements on tantalum, tin, tungsten, and gold (collectively, the “OECD Guidance”).

In order for Accelerate to understand the sources of conflict minerals used in its complex and multi-tiered supply chain, Accelerate has implemented a survey program capitalizing on industry standards set by the RMI. Accelerate requires all suppliers of products containing conflict minerals to conduct due diligence of their supply chains down to the smelters and refiners and report the results to Accelerate on a CMRT. In this regard, Accelerate surveyed all suppliers that contributed to Accelerate’s products manufactured in 2019 and that contained conflict minerals. Accelerate received responses from 100% of the suppliers surveyed.

Accelerate’s instrument electronics suppliers and its supplier of pins for its consumables have identified the smelters used by such suppliers and other sub-suppliers in connection with their supply of these components, and such smelters are identified in the Table 1. The Company’s suppliers have provided it with information at the “company” level. Declarations at the “company” level do not limit the information provided on smelters to those specific to the products that the supplier provides to the Company. Accordingly, the list of smelters that the Company includes is likely to contain more facilities than those that process or refine the conflict minerals contained in its products.

The Company is continuing to evaluate the information provided by its suppliers, and its efforts to diligence its supply chain and obtain origin information regarding the conflicts minerals used in its products are ongoing.

Certain statements in this report may be “forward-looking” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “targets,” “anticipates,” and similar expressions are used to identify these forward-looking statements. Examples of forward-looking statements include statements relating to our future plans, and any other statement that does not directly relate to any historical or current fact. Forward-looking statements are based on the Company’s current expectations and assumptions, which may not prove to be accurate. These statements are not guarantees and are subject to risks, uncertainties and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from these forward-looking statements. As a result, these statements speak only as of the date they are made and the Company undertakes no obligation to update or revise any forward-looking statement, except as required by federal securities laws.

Table 1

Table 1 below lists the facilities, which, to the extent known, processed conflict minerals for the Accelerate Pheno Instrument and Accelerate PhenoTest BC Kit: