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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) |
November 27, 2023 |
Accelerate
Diagnostics, Inc.
(Exact name of registrant
as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation)
001-31822 |
|
84-1072256 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
3950
South Country Club Road, Suite 470,
Tucson, Arizona |
|
85714 |
(Address of principal executive offices) |
|
(Zip Code) |
(520)
365-3100
(Registrant’s
telephone number, including area code)
Not Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title
of each class |
Trading
Symbol |
Name
of each exchange on which
registered |
Common
Stock, $0.001 par value per share |
AXDX |
The
Nasdaq Stock Market LLC
(The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On
November 27, 2023, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing the signing of
a collaboration and quality agreement with Bruker Corporation relating to Accelerate Diagnostics’ Arc™ system. A copy
of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference in its entirety.
Item 9.01. | Financial Statements and Exhibits. |
(d) 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 undersigned hereunto duly authorized.
|
ACCELERATE DIAGNOSTICS, INC.
(Registrant) |
|
|
Date: November 27, 2023 |
|
|
|
|
/s/ David Patience |
|
David Patience |
|
Chief Financial Officer |
Exhibit 99.1
Accelerate Diagnostics
Announces Collaboration for the Use of the Arc™ System in Combination With Bruker´s MALDI Biotyper®
Working together
to bring rapid, automated microbial identification directly from positive blood culture samples
Tucson,
Ariz. (November 27, 2023) – Accelerate Diagnostics, Inc. (NASDAQ: AXDX) an innovator of rapid in vitro diagnostics
in microbiology, announced the signing of a collaboration and quality agreement with Bruker Corporation (NASDAQ: BRKR), the provider
of the market-leading MALDI Biotyper system for microbial identification. This agreement enables both companies to validate the use of
Accelerate Diagnostics’ Arc™ system, an innovative, automated positive blood culture sample preparation platform, with Bruker’s
MALDI Biotyper® sirius instruments and Sepsityper® software for subsequent registration in both the US and EMEA markets.
Designed
for clinical laboratories, the Arc™ system has a simple load-and-go workflow that automates direct from positive blood culture
sample preparation for downstream microbial identification using Bruker’s MALDI Biotyper system. The Arc™ system enables
on-demand processing of samples without the need for an overnight culture incubation, reducing the wait time for identification results.
Labs will be able to leverage the breadth of their Bruker MALDI-Biotyper identification library in combination with rapid phenotypic
antibiotic susceptibility results using the Accelerate Pheno® system, as well as with the Accelerate WAVE™ system
which is currently under development and planned for future release.
The
Arc™ system is designed to compete with molecular positive blood culture identification solutions. Namely, utilization of
Bruker’s Biotyper system, in conjunction with the Arc™ system, offers the potential to reduce the likelihood of cross reactivity
and false positive results that come with rapid molecular tests. In addition, the platform economics are more favorable with the Arc™
system as compared to on-market molecular platforms, especially when laboratories consider that approximately 30% of results are blood
culture contaminants resulting in wasted expense. Finally, clinical laboratories are under pressure to run FDA cleared devices with increased
legislation and enforcement of laboratory developed tests. As such, Accelerate has already initiated a clinical trial with intent to submit
to the FDA over the coming months with the goal of seamless laboratory adoption.
“The
total cost to rapidly identify organisms from positive blood cultures is significantly lower than what labs are paying today for a rapid
molecular ID solution,” said Jack Phillips, President and CEO of Accelerate Diagnostics. “When you think of the extreme demand
that labs are under today, the Arc™ system is a fast and inexpensive diagnostic tool which frees up technician hands and
lab budgets to deliver actionable results in the race against sepsis. We look forward to working with Bruker, the recognized leader in
mass spectrometry-based microbial identification, to bring this much needed solution to laboratories.”
“The
combination of Bruker’s MALDI Biotyper with Accelerate Diagnostics’ Arc™ system to automate positive blood culture
sample preparation and rapid microbial identification will be a valuable addition to many laboratories. Bruker welcomes this collaboration
with Accelerate Diagnostics as both companies are committed to help laboratories in the important fight against sepsis with their leading
products,” said Wolfgang Pusch, President, Bruker Microbiology & Infection Diagnostics.
About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)
Accelerate
Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic
resistance and sepsis. In addition to its Arc™ system, the Accelerate Pheno® system and Accelerate PhenoTest® BC
kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for
deadly infections. The FDA cleared Pheno® system and kit fully automate the sample preparation steps to report phenotypic
antibiotic susceptibility results in approximately 7 hours direct from positive blood cultures. Recent external studies indicate the
solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage
specific to the individual patient days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO"
and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.
For more information about the company, its products and technology,
or recent publications, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward looking
or may have forward-looking implications, such as, among others: intentions and expectations relating to the collaboration and quality
agreement with Bruker, including that the agreement will enable both companies to validate the use of Accelerate Diagnostics’ Arc™
system with Bruker’s MALDI Biotyper® sirius instruments and Sepsityper® software for subsequent registration
in both the US and EMEA markets, as well as the anticipated benefit for laboratories using the platforms in conjunction; expectations
regarding the potential or benefits of Accelerate Diagnostics’ products and technologies; expectations regarding new or planned
products and technologies, including the anticipated timing of any releases, such as with respect to the Accelerate WAVE™ system
currently under development; and intentions and plans relating to regulatory approvals or submission, including with respect to the U.S.
Food and Drug Administration (FDA). Actual results or developments may differ materially from those projected or implied in these forward-looking
statements due to significant risks and uncertainties, including, but not limited to general industry and market conditions, such as
volatility throughout the global economy and the related impacts to the businesses of suppliers and customers, whether due to customer
demand fluctuations, supply chain constraints and inflationary pressures or otherwise, as well as Accelerate Diagnostics’ ability
to obtain any regulatory approvals. Other important factors that could cause Accelerate Diagnostics’ actual results to differ materially
from those in its forward-looking statements include those discussed in the company’s filings with the Securities and Exchange
Commission (the “SEC”), including in the “Risk Factors” sections of the company’s most recently filed periodic
reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. Except as required by federal securities laws, Accelerate
Diagnostics undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other
contingencies.
SOURCE Accelerate Diagnostics, Inc.
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