News & Media

  • Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test

    Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The Diazyme IgG test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.

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

    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 testis NOT subject of delisting.Diazyme decided not to commercialize the RAPID testand hence did not pursue it further.Dia...

  • Diazyme Thanks GA-EMS for Donating Face Shields to Installation Field Team

    SAN DIEGO, CA – (April 14, 2020) – Diazyme would like to thank our GA-EMS family for donating 200 face shields. We are arming our field team with them who are going out and installing our DZ-Lite 3000 Plus analyzers for COVID-19 Antibody tests throughout the United States. Acting quickly to adapt to these uncertain times have made it possible to distribute testing to communities that need it most.

  • Diazyme Laboratories, Inc. Announces Availability of COVID-19 Antibody Tests

    Diazyme announces the availability of two serological tests for the novel coronavirus (SARS-CoV-2), namely the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits.

  • Highlighted Study: Verification of FDA-Cleared Kappa and Lambda Free Light Chain Assays on the Beckman Coulter DxC 800

    SAN DIEGO, CA – (November 14, 2019) In a newly published study, Diazyme’s Kappa and Lambda Free Light Chain Assay performance was verified on the Beckman Coulter DxC 800.“We conclude the Diazyme κ and λ FLC assays when run on the Beckman-Coulter DxC analyzer exhibit excellent precision and accuracy, and are comparable to the Freelite assays on the Roche Cobas Integra analyzer”.Click below to read the full article Verification of Newly FDA-Approved Kappa and L...

  • FDA Grants Diazyme 510(k) Clearance to Market Its 1,5 AG Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA - 5 November 2018 - Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its 1,5 AG assay.

  • Highlighted Study: Circulating Vitamin D and Colorectal Cancer Risk: An International Pooling Project of 17 Cohorts

    SAN DIEGO, CA – (June 19, 2018) In a recent study, It was found that circulating Vitamin D Could Lower Risk Of Colorectal Cancer.“Higher circulating 25(OH)D was related to a statistically significant, substantially lower colorectal cancer risk in women and non–statistically significant lower risk in men. Optimal 25(OH)D concentrations for colorectal cancer risk reduction, 75-100 nmol/L, appear higher than current IOM recommendations.” according to a study published i...

  • FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA – 22 January 2018 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers.

  • FDA Grants Diazyme 510(k) Clearance to Market Its Procalcitonin Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA – 25 April 2017 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Procalcitonin (PCT) assay.

  • FDA Grants Diazyme 510(k) Clearance to Market Its Direct HbA1c (Enzymatic, On-Board Lysis) Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA – 28 November 2016 – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Direct HbA1c assay (Enzymatic, On-Board Lysis).  HbA1c refers to glycated hemoglobin which occurs when hemoglobin, a protein within red blood cells that transports oxygen through the body, joins with glucose in the blood, thereby becoming glycated. Measuring HbA1c allows clinicians to get an overall picture of wh...

  • FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin B Assays for Clinical Chemistry Analyzers

    SAN DIEGO, CA – (Nov 21, 2016) – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearances to market its two B vitamin assays, Vitamin B12 and Folate assays. Vitamin B12 and Folate perform several important functions in the body.

  • Diazyme Prevails in Maintaining Its Right to Distribute Its Procalcitonin (PCT) Test in Germany

    SAN DIEGO, CALIFORNIA, U.S.A., 6 SEPTEMBER 2016 - Diazyme Laboratories announces that it will continue to distribute its procalcitonin (PCT) test in Germany through its German subsidiary Diazyme Europe. This follows the lifting by the district court of Munich on August 31, 2016 of a preliminary injunction obtained by B.R.A.H.M.S. GmbH (BRAHMS) on July 13, 2016 based on alleged infringement of BRAHMS's European PCT patent EP 2 028 493 B1.PCT is a marker for diagnosis of sepsis, and the Diazyme PC...

  • New Study Shows That Four Biomarkers, Including Homocysteine, May Help to Predict the Risk of Stroke

    SAN DIEGO, CA – (August 25, 2016)  In a recent study, multiple biomarkers were examined to see the relationship between them and stroke."People with high levels of four biomarkers in the blood may be more likely to develop a stroke than people with low levels of the biomarkers, according to a study published in the August 24, 2016, online issue of Neurology, the medical journal of the American Academy of Neurology.""Of the 15 biomarkers, four were associated with an inc...

  • Diazyme is Excited to Now Offer the Diadexus PLAC® Assays

    SAN DIEGO, CA - (August 1, 2016) - Diazyme Laboratories today announced that it has purchased substantially all of the assets of Diadexus, Inc. (Diadexus), including all intellectual property. Diazyme is excited to now offer the Diadexus PLAC® assays."Adding the PLAC assays to Diazyme's already comprehensive diagnostic testing for heart disease demonstrates Diazyme's commitment to providing complete clinical diagnostic solutions to doctors and patients” said Dr.

  • FDA Grants Diazyme 510(k) Clearance to Market Its Fibrinogen Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA - (Feb 24, 2016) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Fibrinogen Assay. Fibrinogen is a protein involved in the blood clotting (coagulation) process.

  • Diazyme Assays Featured in Recent Publications

    Diazyme wants to highlight some recent publications that touch on Diazyme's PCT and Vitamin D Assays.  The first from the journal  “Expert Review of Molecular Diagnostics” is titled “First 25-hydroxyvitamin D assay for general chemistry analyzers”  which touches on Diazyme's Vitamin D assay.  The second journal article from the journal “Clin Chem Lab Med 2014”  is titled “Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Bec...

  • Diazyme's Jonathan Dedes Receives AACC Award

    On 9/18/2014, at AACC's (American Association of Clinical Chemistry) 25th International Symposium for Critical and Point of Care testing (CPOCT), Diazyme Scientist Jonathan Dedes received the prestigious award for "outstanding research in critical and point of care testing." The award was presented to Jonathan by Dr. William Clarke, the Chair, CPOCT International Symposium Planning Committee. Mr.

  • FDA Grants Diazyme 510(k) Clearance to Market Its Ferritin Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA - (Marketwired - Jul 7, 2014) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Ferritin Assay. In line with current clinical needs, Diazyme's Ferritin Latex-Enhanced Immunoturbidimetric Assay can be utilized to measure levels of ferritin in serum and plasma samples as part of a work up of patients with iron deficiency issues.

  • FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA-(Marketwire - Mar 24, 2014) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme's new Vitamin D assay, utilizing its femtoquantTM  technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for us...

  • FDA Grants Diazyme 510(k) Clearance to Market Its Myoglobin Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA--(Marketwired - Jul 24, 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Myoglobin assay. In line with current clinical needs, Diazyme's Myoglobin latex-enhanced immunoturbidimetric assay can be utilized to measure Myoglobin in serum and plasma samples as an aid in the diagnosis of acute myocardial infarction.

  • FDA Grants Diazyme 510(k) Clearance to Market Its D-Dimer Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA--(Marketwire - Feb 12, 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its D-Dimer assay. In line with current clinical needs, Diazyme's D-Dimer latex-enhanced immunoturbidimetric assay can be utilized to measure total levels of D-Dimer in plasma samples as part of a work up of patients with blood clotting issues.

  • FDA Grants Diazyme 510(k) Clearance to Market its New 25-Hydroxy Vitamin D Enzyme Immunoassay

    SAN DIEGO, CA--(Marketwire--January 7th 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its new 25-Hydroxy Vitamin D assay.  In line with current clinical needs, Diazyme's new 25-Hydroxy Vitamin D Assay measures total true 25-Hydroxy Vitamin D levels (D2 + D3 levels) in both serum and plasma samples. Furthermore, the assay fully automates the removal of non-specific protein binding and cross reactivity that...

  • FDA Grants Diazyme Clearance to Market a New Biomarker for Early Detection of Kidney Disease, on the SMART Point of Care System

    SAN DIEGO, CA - Nov 8, 2012 -  Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C POC Test Kit on the SMART Point of Care System. The SMART Point of Care chemistry system offers a wide range of rapid testing capabilities for cardiovascular and stroke risk, diabetes monitoring and now early detection of acute and chronic kidney disease.  The Cystatin C POC Test Kit is the first to employ thi...

  • Diazyme Receives 510(k) FDA Clearance for Enzymatic Glycated Serum Protein (Glycated Albumin) Assay Kit

    FOR IMMEDIATE RELEASEMay 25, 2011SAN DIEGO, CA--(Marketwire - May 24, 2011) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Glycated Serum Protein (GSP, Glycated Albumin) Assay Kit.Recent studies have shown that blood HbA1c levels alone may not accurately reflect serum glucose concentrations in all diabetic patients. The difference between the actual measured HbA1c concentration and the predicted...

  • Diazyme Receives FDA 510(k) Clearance for Vitamin D Assay

    FOR IMMEDIATE RELEASE Jan 24, 2011 SAN DIEGO, CA--(Marketwire - January 24, 2011) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its 25-Hydroxy Vitamin D assay. Diazyme's 25-Hydroxy Vitamin D test is an innovative homogenous assay which measures the true total 25-Hydroxy Vitamin D (sum of both D3 + D2).

  • Diazyme Receives FDA 510(k) Clearance to Market SMART HbA1c Assay on Its SMART Point of Care System for Diabetes Monitoring

    FOR IMMEDIATE RELEASE May 07, 2010 SAN DIEGO, CA--(Marketwire - May 7, 2010) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its SMART HbA1c Assay on its new SMART Point of Care System for diabetes monitoring. The SMART HbA1c Assay offers rapid testing capabilities and is based on Diazyme's proprietary Direct Enzymatic HbA1c assay technology.

  • Diazyme Homocysteine Test Receives AACC Award

    FOR IMMEDIATE RELEASEJul 20, 2009July 20, 2009 San Diego: Dr. Chong Yuan, Managing Director of Diazyme Laboratories Division, General Atomics, received the 2009 Pacific Biometrics Research Foundation Award at the annual meeting of American Association for Clinical Chemistry (AACC) held in Chicago on July 20th, 2009.The Award was presented to Dr. Yuan by Dr.

  • Diazyme Introduces Liquid Stable Enzymatic Lithium Test

    FOR IMMEDIATE RELEASE Dec 15, 2008 its Liquid Stable Enzymatic Lithium Test Kit for the quantitative determination of lithium levels in blood samples. Compared to existing methods, the new Diazyme lithium assay provides improved reagent stability and a reduced cost per test. The assay features excellent accuracy and precision and offers an extended reportable range of 0.1-3.0 mmole/L lithium which will reduce the need for re-testing elevated patient samples.

  • Federal Circuit Affirms Ruling That Diazyme's Homocysteine Assay Does Not Infringe Axis-Shield's Patents

    SAN DIEGO, CA--(Marketwire - May 12, 2008) - The United States Court of Appeals for the Federal Circuit issued a ruling today unanimously holding that Diazyme Laboratories' enzymatic homocysteine assay does not infringe two U.S. patents held by Axis-Shield, ASA, a Norwegian company. The three-judge panel affirmed two previous rulings by the U.S.

  • Diazyme Receives FDA 510(k) Clearance for LDL-Cholesterol Assay

    FOR IMMEDIATE RELEASE Mar 06, 2008 POWAY, CA - March 6, 2008 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its LDL-Cholesterol Assay Kit for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. Diazyme uses a modified PVS and PEGME coupled classic precipitation method.

  • Diazyme Receives FDA 510(k) Clearance for HDL-Cholesterol Assay

    FOR IMMEDIATE RELEASE Mar 06, 2008 POWAY, CA - March 6, 2008 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its HDL-Cholesterol Assay Kit for the quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. Diazyme uses a modified PVS and PEGME coupled classic precipitation method.

  • Diazyme Introduces New Test for the Early Detection of Kidney Disease

    FOR IMMEDIATE RELEASE Feb 26, 2008 POWAY, CA - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C Assay Kit for the quantitative determination of Cystatin C in serum and plasma samples. Cystatin C is emerging as a biomarker superior to standard tests of kidney function in the early detection of chronic kidney disease.

  • Diazyme Receives FDA 510(k) Clearance for Low Cost Enzymatic Creatinine Assay

    FOR IMMEDIATE RELEASE May 03, 2007 SAN DIEGO, CA -- (MARKET WIRE) -- May 03, 2007 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Creatinine Assay Kit for the quantitative determination of creatinine in serum and urine samples. The Diazyme method is a liquid stable, two reagent system which uses coupled enzyme reactions which are more specific and sensitive than conventional non-enzymatic method...

  • Diazyme Receives FDA 510(k) Clearance and NGSP Certification for Its Direct Enzymatic HbA1c Assay Product

    SAN DIEGO, CA--(MARKET WIRE)--Apr 19, 2007 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit for the quantitative determination of HbA1c in human whole blood samples.The company also announced today that it has successfully completed the National Glycohemoglobin Standardization Program (NGSP; www.ngsp.org) manufacturer certification for this assay. The Diazy...

  • Diazyme Laboratories Is Granted Second Summary Judgment of Noninfringement Regarding Homocysteine Assay Patents

  • European Patent Office Decision Favors Diazyme Laboratories

  • Diazyme Laboratories Is Granted Summary Judgment of Noninfringement Regarding Homocysteine Assay Patents

  • Diazyme Receives NGSP Certification of Traceability for the Enzymatic HbA1c Assay Product

  • Diazyme Receives FDA 510(k) Clearance for Enzymatic Total Bile Acids Assay Kit

    FOR IMMEDIATE RELEASEDec 22, 2005SAN DIEGO, CA - Dec 22, 2005 - Diazyme Laboratories, a company that applies its proprietary enzyme technologies to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Total Bile Acids (TBA) Assay Kit for the quantitative determination of total bile acids in human blood samples.Total bile acids is a well kn...

  • Diazyme Receives 510(K) FDA Clearance for Enzymatic Hemoglobin A1c Assay Kit

    FOR IMMEDIATE RELEASEJul 18, 2005SAN DIEGO, CA - July 12, 2005 - Diazyme Laboratories, a company that applies its proprietary protein engineering and SubstrateTrapping-Enzyme Technology® (STE) platforms to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Hemoglobin A1c (HbA1C) Assay Kit for the quantitative determination of HbA1c in ...

  • Diazyme Receives CE Mark for the Homocysteine, Lithium, Sodium, and Potassium Assays

  • Diazyme Receives 510(K) FDA Clearance for Potassium Enzymatic Assay Kit

    SAN DIEGO, CA - October 29, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Potassium Enzymatic Assay Kit for the quantitative in vitro determination of potassium in serum samples.Potassium is determined spectrophotometri...

  • Diazyme Receives 510(K) FDA Clearance for Glycated Serum Protein Assay Kit

    SAN DIEGO, CA - October 29, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Glycated Serum Protein (GSP) Assay Kit for the quantitative in vitro determination of glycated serum proteins in human serum.The Diazym...

  • Diazyme Receives 510(K) FDA Clearance for Enzymatic Homocysteine Assay Kit

    SAN DIEGO, CA - Oct. 29, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) to develop low cost and high quality diagnostic products for clinical and research uses, announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market the Enzymatic Homocysteine Assay Kit.Diazyme has developed an assay kit to determine plasma homocysteine levels based onits proprietary co-substrate conversion product b...

  • Diazyme Receives 510(K) FDA Clearance for Sodium Enzymatic Assay Kit

    SAN DIEGO, CA - October 4, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Sodium Enzymatic Assay Kit for the quantitative in vitro determination of sodium in serum samples.Sodium is determined enzymatically via sodium de...

  • Diazyme Receives ISO 13485:2003 Certification

  • Diazyme Receives 510(K) FDA Clearance for Enzymatic Lithium Assay Kit

    SAN DIEGO, CA - December 23, 2003 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Lithium Assay Kit for the quantitative in vitro determination of lithium in human serum.With Diazyme's Enzymatic Lithium Assay, serum...

  • Diazyme Receives 510(K) FDA Clearance for Homocysteine Assay Kit

    SAN DIEGO, CA - Sept. 3, 2003 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) to develop low cost and high quality diagnostic products for clinical and research uses, announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market the Homocysteine Microtiter Plate Assay Kit.Diazyme has developed a Microtiter Plate Assay Kit to determine plasma homocysteine levels based on the STE Technology®.