Ad blocking detected

Thank you for visiting We have detected you cannot see ads being served on our site due to blocking. Unfortunately, due to the high cost of data, we cannot serve the requested page without the accompanied ads.

If you have installed ad-blocking software, please disable it (sometimes a complete uninstall is necessary). Private browsing Firefox users should be able to disable tracking protection while visiting our website. Visit Mozilla support for more information. If you do not believe you have any ad-blocking software on your browser, you may want to try another browser, computer or internet service provider. Alternatively, you may consider the following if you want an ad-free experience.

Canadian Insider Club
$299/ year*
Daily Morning INK newsletter
+3 months archive
Canadian Market INK weekly newsletter
+3 months archive
30 publication downloads per month from the PDF store
Top 20 Gold, Top 30 Energy, Top 40 Stock downloads from the PDF store
All benefits of basic registration
No 3rd party display ads

* Price is subject to applicable taxes.

Paid subscriptions and memberships are auto-renewing unless cancelled (easily done via the Account Settings Membership Status page after logging in). Once cancelled, a subscription or membership will terminate at the end of the current term.

Diazyme Announces Continued Availability of COVID-19 Laboratory Run Antibody Tests

SAN DIEGO, Calif., May 22, 2020 (GLOBE NEWSWIRE) -- Diazyme is making a statement to clear any confusion due to FDA’s May 21 press release regarding delisted tests from the FDA FAQ website.

Diazyme had two types of tests under Section IV.D notification of FDA’s policy on the public health emergency for COVID-19.  The Diazyme high-throughput laboratory run CLIA antibody test is NOT subject of delisting. 

Diazyme decided not to commercialize the RAPID test and hence did not pursue it further.

Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA serological tests were FDA notified pursuant to Section IV.D of FDA’s policy on the public health emergency for COVID-19 (May 4, 2020 update compliant).  Diazyme CLIA serological tests have been validated per Section V.C of the FDA policy on PHE for COVID-19.  FDA has acknowledged the notification by posting the Diazyme serological method under FAQ section on serological tests. 

Please see “Q.  What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D…..”

Diazyme has already submitted EUA for the laboratory run SARS-CoV-2 IgG/IgM CLIA kit, which are currently under FDA interactive review.

About Diazyme
Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at

For Further Information Contact Diazyme Support:

Emile Dergham

Comment On!

Upload limit is up to 1mb only
To post messages to your Socail Media account, you must first give authorization from the websites. Select the platform you wish to connect your account to (via Easy Blurb).