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MedTest Announces Commercial Availability of Four New “Forensic Use Only” Urine Drug Screening Reagents to Its Broad Test Menu

Nov 10, 2017 - press releases

(Canton, Michigan) MedTest announced the commercial availability of four new “Forensic Use Only” urine drug tests for use on its BS-200, BS-480 and BA-800M Chemistry Analyzers. The addition of these products broadens MedTest’s menu of urine drug screening reagents currently available.

The four new assays are: DRI Fentanyl, CEDIA AB-PINACA (Spice K2), CEDIA UR-144/XLR-11 (Spice K2) and DRI Ethyl Glucuronide.

In the United States, Forensic Use Only products may only be sold to laboratories associated with the criminal justice system as these products have not been cleared by the US Food and Drug Administration (FDA) via the Section 510(k) pre-market notification process. These products are not intended to be used for In Vitro Diagnostic Use and may not be used for medical or diagnostic purposes to identify ailments, dependency or illness. To insure compliance with the FDA regulations for Forensic Use Only products, MedTest will require customers to sign an acknowledgement letter that will be kept on file before these products will be shipped.

Wayne Brinster, CEO of MedTest, stated: “With the emerging focus on the Opioid Crisis in the United States, MedTest is pleased to be able to offer these tests on our scalable chemistry instruments used in criminal justice laboratories. Whether test volume is low or high, MedTest can provide a “right-sized” testing solution that will optimize laboratory operations and provide cost-effective instrument and reagents.”

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. In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS). In the spring of 2017, MedTest acquired Medical Laboratory Solutions, providing instrument replacement parts, new and re-certified clinical laboratory equipment, in addition to a wide range of cost-effective service programs for commercially available instruments.

For additional information, please contact:

MedTest
Debbie Whitehair, MT(ASCP)SC
Vice President, Marketing
484-748-1603
dwhitehair@medtest.com
www.medtest.com

PR-D2111-02   10/17

MedTest Announces the Worldwide Commercial Launch of a Comprehensive Chemistry Menu specifically Manufactured, Packaged, and Barcoded for the BioLis 24i Instrument

Jul 13, 2017 - press releases

(Canton, Michigan)  Utilizing its high-quality Pointe Scientific product brand, MedTest has developed a full line of chemistry reagents that are manufactured and packaged in barcoded reagent containers specifically for use on the BioLis 24i Chemistry Analyzer (also known as the CLC480 or MGC 240 Chemistry Analyzer). The menu consists of 31 general chemistry assays, including specialty tests like direct Hemoglobin A1c, autoHDLTM and autoLDLTM Cholesterol, Microalbumin, and Microprotein, to name a few.

Hanjoon Ryu, CEO of MedTest, stated: “MedTest is privileged to introduce this full chemistry menu for the BioLis 24i analyzer to the worldwide market. Pointe Scientific has been developing, manufacturing, and distributing clinical chemistry reagents worldwide since 1981. Since its acquisition by MedTest, Pointe Scientific’s robust R&D program continues to focus on the continual improvement of its existing products, while introducing new products and technologies to the marketplace. The newest introduction of a fully packaged and barcoded chemistry menu specifically created for the BioLis 24i analyzer is one more example of our dedication to bringing new and economical products to the market that provide our customers with clinical, operational, and financial value.”

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 that include clinical chemistry reagents and instruments in the United States and internationally since 1981. In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS). In February 2017, MedTest acquired Medical Laboratory Solutions, a provider of economical reagents and controls, consumable supplies, instrument replacement parts, new and re-certified clinical laboratory equipment, as well as a wide range of cost-effective instrument service programs.

For additional information, click here or please contact:

MedTest
Debbie Whitehair, MT(ASCP)SC
Vice President, Marketing
484-748-1603
dwhitehair@medtest.com
www.medtest.com

                                                              

PR-P2111-01   06/17

MedTest announces Commercial Launch of Drugs of Abuse Screening on the BA-800M Chemistry Analyzer

Feb 21, 2017 - press releases

(Canton, Michigan)  MedTest announces the commercial launch of urine drugs of abuse screening reagents on the Mindray BA-800M Chemistry Analyzer for use in clinical laboratories in the United States.

The broad urine drugs of abuse screening menu available on the BA-800M meets the three challenges of large volume laboratories performing such testing:  efficiency in processing a large number of samples, efficiency in reagent utilization and reduced overall operating costs.  A complete chemistry testing menu is also in development for the BA-800M analyzer. 

The BA-800M Chemistry Analyzer produces 800 photometric test results per hour with an overall throughput of 1200 tests per hour with ISE.  The Sample Delivery Module provides a sample capacity of 440 positions, providing large-volume laboratories hours of unmanned operational time.  The reagent consumption design of this analyzer minimizes reagent usage per test and reduces the reagent bottle dead volume insuring that the laboratory is efficiently utilizing the reagents and providing the lowest consumption cost per test.   Advanced features of the BA-800M Analyzer offer processing efficiencies such as continuous reagent loading, Reagent Bubble Detection, Water Quality Monitor, One-Key STAT Touch button, Probe Liquid Level and Clot Detection, and Collision Recovery which provides the laboratory with smooth operational and enhanced workflow efficiencies.  A unique capability is that the BA-800M can be twinned to double the operating and throughput capacity for those labs that need to grow their testing capability. 

Hanjoon Ryu, CEO of MedTest, stated: “MedTest is privileged to introduce this model, designed for the large-volume laboratory, to the US market.  Adding the BA-800M to our instrument portfolio of the BS-200 and the BS-480 enhances our testing solutions across the board from small volume labs to very large volume labs.  Being able to twin the BA-800M analyzer provides the laboratory with confidence that they can double their testing volume without having to adopt a new testing system and all of the corresponding validation work associated with a new system.”

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.  In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS).

For additional information:

MedTest
Debbie Whitehair, MT(ASCP)SC
Vice President, Marketing
484.748.1603
dwhitehair@medtest.com
www.medtest.com

PR-M1114-02   11/16

Medical Laboratory Solutions Has Become a Subsidiary of MedTest

Feb 9, 2017 - press releases

(Canton, Michigan)  MedTest Holdings, the parent company of MedTest, has signed a definitive agreement to acquire Medical Laboratory Solutions (MLS) located in Fletcher, North Carolina. 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 confirmation testing and wellness testing. 

Medical Laboratory Solutions was founded in 1995.  Medical Laboratory Solutions provides economical reagents and controls, consumable supplies, instrument replacement parts, new and re-certified clinical laboratory equipment in addition to a wide range of cost-effective service programs.

Hanjoon Ryu, CEO of MedTest, stated:  “The addition of Medical Laboratory Solutions to the MedTest family enables us to become a highly differentiated provider of extensive service offerings to laboratories in the United States.  Securing a nationwide service organization provides the laboratory with peace of mind and broadens the spectrum of solutions from MedTest.  Our four renowned brands - Medical Laboratory Solutions, Pointe Scientific, Clinitox Diagnostix and MedTestDX - provides extensive clinical expertise to delivering scalable chemistry and hematology instrumentation, barcoded chemistry reagent lines, open-channel chemistry reagents, drugs of abuse screening and confirmatory reagents, hematology reagents and service to the US laboratory.  MedTest is positioned to service individual laboratory testing needs as well as the needs of the growing hub-and-spoke laboratory networks.”

We at MLS and MedTest are appreciative of the support from customers and partners and we look forward to providing you with the same high level of customer service that you are accustomed to.  For additional information, please contact your local sales or service representative or the marketing representatives below. 

For additional information:

Medical Laboratory Solutions MedTest
Tom Sims Debbie Whitehair, MT(ASCP)SC
Senior Director and General Manager Vice President, Marketing
826.676.2801 484.748.1603
tom@medlabsolutions.com dwhitehair@medtest.com
www.medlabsolutions.com www.medtest.com

Mindray and MedTest announce FDA 510(k) Clearance for the BC-5390 Hematology Analyzer

Sep 14, 2016 - press releases

(Mahwah, New Jersey & Canton, Michigan)  Mindray announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray BC-5390 Auto Hematology Analyzer.  The Mindray BC-5390 Analyzer meets the testing needs of mid-volume hematology laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.  The built in autoloader with 40 sample capacity enhances operator walk-away time. Hemoglobin analysis is performed using cyanide-free reagents. The analyzer processes up to 60 samples per hour and stores up to 100,000 results with histograms. The barcode reader and optional LIS connectivity enables seamless sample data transmission.  Nearly all scheduled maintenance procedures are automated by touch buttons.  The intuitive software enhances workflow efficiency and offers the operator a pleasant user experience.” 

Caroline Li, General Manager of Mindray IVD North America, stated:  “We are excited to launch the BC-5390 Hematology 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.  The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.  This commercialization further enhances Mindray’s 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 a primary distributor of the BC-5390 Hematology Analyzer in the US and Canada. Hanjoon Ryu, CEO of MedTest, stated: “Partnered with the bench-top BS-200 Chemistry Analyzer, the BS-480 Chemistry Analyzer or the BA-800M Chemistry Analyzer, the addition of the BC-5390 Hematology Analyzer enables MedTest to offer a total testing solution that meets the requirements of both the hematology and chemistry laboratories. 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.  In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS).

For additional information:

MedTest Mindray
Debbie Whitehair, MT(ASCP)SC Caroline Li 
Vice President, Marketing General Manager of  Mindray IVD North America
484.748.1603 800.288.2121 Ext. 2152
dwhitehair@medtest.com c.li@mindray.com
www.medtest.com www.mindraynorthamerica.com

PR-M1115-01   09/16

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