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MedTest Announces Acquisition of Clinitox Diagnostix

Oct 28, 2014 - press releases

(Canton, Michigan)  MedTest Holdings (“MedTest”), the parent company of MedTest DX and Pointe Scientific, has signed a definitive agreement to acquire Clinitox Diagnostix located in Mississauga, Ontario, Canada.  MedTest is an in-vitro diagnostics company providing automated, fast and cost-effective blood and urine testing solutions for diabetes, cardiovascular disease, urine drugs of abuse screening and wellness testing.

Clinitox Diagnostix was founded in 2010 by Howard Lee.  Clinitox Diagnostix provides drugs of abuse confirmatory testing capabilities via liquid chromatography/mass spectrophotometry (LC/MS) instrumentation and associated reagents and consumables as pre-packaged kits.  Implementation consulting provides the customer with on-site assistance in setting up their LC/MS testing and developing the standard operating procedures enabling the laboratory to initiate testing sooner and reduce costly start-up costs.

Hanjoon Ryu, CEO of MedTest, stated:  “The addition of Clinitox Diagnostix to our portfolio enables us to become a highly differentiated provider of extensive solutions in the drugs of abuse testing market.  Now we can provide the laboratory with confirmatory drugs of abuse testing capability in addition to the urine drugs of abuse screening testing that can be performed on the Mindray™ BS-200 and BS-480 Chemistry Analyzers.  Our clinical expertise in the drugs of abuse testing market meets both individual laboratory testing needs as well as the needs of the growing hub-and-spoke regional toxicology networks.”

In addition to manufacturing and distribution of reagents, calibrators and quality control products for the general chemistry and drugs of abuse testing markets, MedTest is the exclusive US distributor of the Mindray™ floor model BS-480 Chemistry Analyzer and the bench-top BS-200 Chemistry Analyzer.  The acquisition of Clinitox enables MedTest to provide a more integrated service offering of innovative instruments with proven quality reagents, superior customer support and recognized economic advantages. 

For additional information, please contact:

Debbie Whitehair, MT(ASCP)SC

Vice President, Marketing

484-748-1603

dwhitehair@medtest.com

PR-M3111-01   10/14

Mindray and MedTest announce FDA 510(k) Clearance for the BS-480 Chemistry Analyzer

Sep 4, 2014 - press releases

For Immediate Release:

(Mahwah, New Jersey & Canton, Michigan)  Mindray™ and MedTest jointly announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray™ BS-480 Chemistry Analyzer.  The Mindray™ BS-480 Analyzer meets the testing needs of mid-volume laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BS-480 Analyzer produces 400 photometric test results per hour, 240 ISE tests per hour with an overall throughput of 560 tests per hour.  Advanced features of the BS-480 analyzer include numerous automatic processes such as Auto-Start-Up, QC, Rerun, Pre-dilution, Post-dilution, ISE Calibration, Probe Cleaning, Reagent Blank Checks and Probe Collision Recovery which provides the laboratory with smooth operational and enhanced workflow efficiencies. 

Finn Li, Ph.D., General Manager, Mindray™ IVD North America, stated:  “We are excited to launch the BS-480 analyzer into the United States laboratory market.  Mindray™ enjoys satisfied customer experiences with this analyzer outside of the US and looks forward to adding US customers to our installed base.  As Mindray™ has grown rapidly in global markets; the commercialization of the BS-480 further enhances our presence in the US in-vitro diagnostic market, enabling us to continue to introduce new and innovative products for the clinical laboratory in the future.”

MedTest is the exclusive US distributor of the BS-480 Chemistry Analyzer including manufacturing and distribution of reagents, calibrators and quality control products for the general chemistry and drugs of abuse testing markets.  Hanjoon Ryu, MedTest’s CEO, stated: “Mid- and mid-high volume laboratories deserve a more integrated service provider who offers innovative instruments with proven quality reagents, superior customer support and recognized economic advantages.  Partnered with the bench-top BS-200 Chemistry Analyzer, the BS-480 Analyzer enables MedTest to offer a unique testing solution for the Integrated Delivery Networks (IDNs) and Group Purchasing Organizations (GPOs) in the United States.  Our solution will provide commutable testing results between the core laboratory and satellite laboratory.  We are delighted to share this announcement with our strategic partner, Mindray™.”

About Mindray™:  Mindray™ is a leading developer, manufacturer and marketer of medical devices worldwide. Mindray™ maintains the global headquarters in Shenzhen, China, the U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From the main manufacturing and engineering base in China, Mindray™ supplies through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.

For additional information, please contact:

                                                                                              

Mindray™   MedTest
Finn Li, Ph.D. Debbie Whitehair, MT(ASCP)SC
General Manager, Mindray™ IVD North America    Vice President, Marketing
905-886-0589 Ext. 2158      484-748-1603
Finn.Li@mindray.com     dwhitehair@medtest.com
www.mindraynorthamerica.com       www.medtest.com

                                                                                             

PR-M1112-01   09/14

Optimized Application Released For autoHDL™ and the Beckman AU 400 Analyzer

Aug 11, 2014 - news

The purpose of this advisory is to alert users of the Pointe Scientific autoHDL™ reagent (catalog #: OH945-480) and the Beckman AU 400, that optimized instrument parameters have been released.

The new application will provide optimized performance. The optimization was a revision in the primary and secondary wavelengths utilized. Please review the attached revised package insert and Instrument application reviewing Instrument Parameter settings closely.

When implementing a change in an application, users may notice a slight shift in their quality control data. Please incorporate this Bulletin into your Quality Control files.

For more information, follow this link.

MedTest introduces the Pointe Scientific Cystatin C Reagent

May 27, 2014 - press releases

For Immediate Release:  MedTest Introduces the Pointe Scientific Cystatin C1 Reagent

(Canton, Michigan) – MedTest introduces the Pointe Scientific Cystatin C1 Reagent.  The reagent is a latex-enhanced immunoturbidimetric assay for the quantitative determination of Cystatin C in human serum, heparinized-plasma, or EDTA-plasma. The reagent can be used on many automated clinical chemistry analyzers. The reagent kit with an assay range of 0.2 to 8.0 mg/L shows excellent correlation with other commercially available assays.

Cystatin C is mainly used as a biomarker of kidney function. Unlike creatinine results for estimating glomerular filtration rates (eGFR), Cystatin C is not dependent on age, sex, race, weight or other parameters.  It is widely published to be a better indicator of early kidney damage and can determine more accurately and more quickly any changes in renal function.  Recently, it has been reported that the use of Cystatin C alone or in combination with creatinine strengthens the association between eGFR and the risks of death and end-stage renal disease across diverse populations2.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.

For additional information, please visit www.pointescientific.com or contact:

Debbie Whitehair

Vice President, Marketing

484-748-1603

dwhitehair@medtest.com 

1   For Research Use Only in the USA. Not available for clinical human blood testing in the USA

2   Shlipak MG, et al, Cystatin C versus Creatinine in Determining Risk Based in Kidney Function, N Engl J Medicine 2013; 369: 932-43.

PR-C7584-01   05/14 

Martin Charles named Technical Service Manager at MedTest

Mar 28, 2014 - news

Ron Jamison, Vice President - Director of Technical Operations, has announced the elevation of Martin Charles to Technical Service Manager. Mr. Charles has worked as a Clinical Laboratory Technologist for over 20 years and has honorably served his country as a Medical Laboratory Specialist in the United States Army during the Persian Gulf War. Martin is currently a New York State Licensed Clinical Laboratory Technologist and is a University of West Florida graduate. 

Martin will lead MedTest's Technical Service team in achieving and maintaining the highest degree of customer satisfaction and technical service related to product installations and performance.

Everyone at MedTest congratulates Martin and wishes him much success.   

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