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EX-99.1 - EX-99.1 - Diadexus, Inc.d760220dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): July 17, 2014

 

 

diaDexus, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   0-26483   94-3236309

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

349 Oyster Point Boulevard, South San Francisco, California 94080

(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (650) 246-6400

N/A

(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))

 

 

 


Item 8.01. Other Events.

On July 17, 2014, diaDexus, Inc. (the “Company”) issued a press release announcing that it has received notice from the U.S. Food and Drug Administration that an administrative acceptance review was conducted on the traditional 510(k) submission of the PLAC Test for Lp-PLA2 Activity, and it was found to contain all of the necessary information needed to proceed with the substantive review. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press release entitled “diaDexus Announces FDA Acceptance for Review of 510(k) Submission for PLAC Test for Lp-PLA2 Activity” issued by diaDexus, Inc. on July 17, 2014.


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.

 

        diaDexus, Inc.
    (Registrant)
Date: July 18, 2014      
    By:  

/s/ Jean-Frédéric Viret

      Jean-Frédéric Viret
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press release entitled “diaDexus Announces FDA Acceptance for Review of 510(k) Submission for PLAC Test for Lp-PLA2 Activity” issued by diaDexus, Inc. on July 17, 2014.