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Withdrawal of 510(k) Submission - Chlamydia Assay

29 May 2018 07:00

RNS Number : 4405P
Akers Biosciences, Inc.
29 May 2018
 

May 29, 2018

 

Akers Biosciences, Inc.

 

Withdrawal of FDA 510(k) Submission for PIFA Chlamydia Rapid Assay

 

Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers Bio" or the "Company"), a developer of rapid health information technologies, announces that, upon a recommendation from the US Food and Drug Administration (FDA), the Company has decided to withdraw its initial 510(k) application for PIFA Chlamydia in order to re-evaluate its options with regards to this product development opportunity.

John J. Gormally, Chief Executive Officer of Akers Bio, commented: "The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the Company, and the board believes this course of action will allow the board and management to better evaluate all options.

At the same time, we remain focused on driving sales growth of our currently commercialized products and, in particular, PIFA Heparin/PF4 Rapid Assay, through expanded distribution and a strategic focus on clinical end-users and integrated delivery network customers."

About Akers Biosciences, Inc.

Akers Bio develops, manufactures, and supplies rapid screening and testing products designed to deliver quicker and more cost-effective healthcare information to healthcare providers and consumers. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company's state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. The Company has aligned with major healthcare companies and high volume medical product distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics.

Additional information on the Company and its products can be found at www.akersbio.com. Follow us on Twitter @AkersBio.

 

Cautionary Statement Regarding Forward Looking Statements

 

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company's expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. The forward-looking statements include statements or expectations regarding research and development efforts, the effect of regulation by the United States Food and Drug Administration (the "FDA") and other agencies, regulatory clearance and the timing of FDA filings or approvals, current and planned future business plans, clinical studies, other matters related to the Company's pipeline of product candidates, future financial performance, the impact of competitive products, product development commercialisation and technological difficulties, other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission and other future events. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Akers Biosciences, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company's actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

 

For more information:

 

Akers Biosciences, Inc.

John J. Gormally, Chief Executive Officer

Tel. +1 856 848 8698

 

finnCap (UK Nominated Adviser and Broker)

Adrian Hargrave / Scott Mathieson (Corporate Finance)

Steve Norcross (Broking)

Tel. +44 (0)20 7220 0500

 

Vigo Communications (Global Public Relations)

Ben Simons / Fiona Henson

Tel. +44 (0)20 7830 9704

Email: akers@vigocomms.com

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
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MSCDXGDURSDBGII
Date   Source Headline
22nd Nov 200512:00 pmRNSHolding(s) in Company
15th Nov 20055:22 pmRNSHolding(s) in Company
14th Nov 20057:01 amRNSChange of Adviser
3rd Nov 20054:50 pmRNSIssue of Equity
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27th Sep 20056:00 amPRNInterim Results
19th Sep 20056:00 amPRNNotice of Results
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27th Jun 20056:00 amPRNUK Distribution Update
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22nd Jun 20054:19 pmRNSIssue of Equity
27th May 20057:00 amRNSIssue of Shares
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12th Apr 20055:49 pmRNSIssue of Equity
12th Apr 20056:00 amPRNFinal Results
14th Mar 20057:00 amPRNFinancing Agreement
1st Mar 20057:00 amPRNFDA Review On Akers Product
22nd Feb 20057:00 amPRNRe. Distribution Agreement
16th Feb 20055:22 pmRNSIssue of Equity
14th Feb 20057:00 amPRNRe Agreement
26th Jan 20054:28 pmRNSIssue of Equity
14th Jan 20057:00 amPRNTrading Update

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