EDI’s 2012 tradeshow schedule
- American Academy of Pain Medicine
2/23 - 2/26/12 - National Indian Gaming Assoc.
4/1-4/4/12 - Drug and Alcohol Testing Industry Assoc.
4/18-4/20/12 - Society of Forensic Toxicologists
7/1-7/6/12 - American Assoc. of Clinical Chemistry
7/15-7/19/12
Express Diagnostics News
EDI announces interim Quality Manager
Express Diagnostics Int’l announced today that Scott Clarke, quality assurance manager, is no longer with the company. Clarke joined the organization in 2009. “All of us at Express Diagnostics thank Scott for his service during his tenure at Express Diagnostics,” says Paul Johnson, CEO. “We wish him well as he pursues other opportunities.”
The Quality Department will be led on an interim basis by Martin Lueders, who will serve as Quality Manager until recruitment of a full-time replacement is completed. Lueders brings extensive medical device experience to the position, specifically in quality system implementation and process development. He is a certified Project Management Professional (PMP) with over 12 years of experience in medical device design and manufacturing, ranging from reagent testing kits to MRI coils and mobile X-ray systems. Lueders currently serves as quality systems project manager with NAMSA, a contract research organization specializing in providing medical device services.
Prior to joining NAMSA, Lueders was the quality manager at Phillips Plastics, Design Development Center in Hudson, WI. Previous responsibilities also include product development and quality roles with GE Healthcare and St. Jude Medical, Atrial Fibrillation Division.
“We are excited to welcome Martin to the EDI team on an interim basis,” says Johnson. “His breadth of quality assurance experience in medical device manufacturing will be a great asset as we further develop our quality system to continue to meet or exceed our customers’ expectations.”
Express Diagnostics begins final phase of current expansion
Express Diagnostics Int’l (EDI) recently started the final phase of an expansion project that began in December 2010. The first phase of expansion added approximately 9,000 sq. ft. of office, production, and warehouse area. The last phase of the current expansion project includes the addition of 700 sq. ft. of conditioned space to the existing production room, which will allow EDI to add two more production lines.
“The new space will help us streamline our process and increase our efficiency,” says Vice President and General Manager Gary Jueneman. “We’re also redesigning our current production lines to make them more efficient,” adds Jueneman. “We expect that this will give us the capacity to increase our production by well over 50% once we are ramped up.”
EDI expects the production room addition to be complete in early January. “We are very excited about this expansion,” says Jueneman. “It will give us the ability to better service our customers as we look forward to increased business in 2012 and beyond. As we get the remodel done, we’re also excited that we will be creating new jobs.”
EDI announces new personnel assignments
Express Diagnostics announces promotion of Jueneman to Vice President/General Manager
Express Diagnostics Int'l is pleased to announce the promotion of Gary Jueneman to vice president/general manager. Jueneman joined EDI in January 2011 as director of operations.
“Since Gary joined EDI in January of this year, he has demonstrated an ability to not only manage day-to-day operations, but drive improvements in processes to meet the ever changing production demands of our growing organization,” said Paul Johnson, CEO of Express Diagnostics. “His experience and skillset will be central to our ability to seize significant opportunities we foresee for 2012 and beyond.”
Jueneman’s new duties include greater involvement in long-term planning for the organization, as well as increased oversight of regulatory affairs. He will continue to oversee the activities of customer service, production, quality assurance, warehousing, and shipping.
Prior to joining EDI, Jueneman was manager of warehouse operations for Farley's & Sather's Candy with responsibility for operations of three major distribution centers, as well as three manufacturing facilities in the U.S. and Mexico. During his tenure he managed activities for shipping, receiving, inventory control and accuracy, and daily operations, as well as long-term warehousing needs planning and execution.
Huntington named Finance Manager
EDI recently announced Karen Huntington as finance manager. She had served as office manager since joining the organization in 2004 as employee number two. While she will continue to perform many of her previous duties, Huntington’s new role will involve increased oversight of budgeting and financial planning to anticipate and meet the demands of continued company growth.
“Karen has ‘worn many hats’ at EDI during her tenure, but none more important than her role of managing finances and cashflow,” said Johnson. “We will continue to rely on her knowledge and insight as we transition into the next stage of our growth plan.”
Skaden promoted to Sales Manager
Express Diagnostics recently promoted Nick Skaden to sales manager at the organization. In addition to his previous duties as business development manager, Skaden will be further involved in developing distributor relationships and international sales accounts. Skaden joined EDI in 2009.
“Nick’s promotion to sales manager is a result of consistent performance in his role as business development manager,” said Johnson. “As sales manager he will continue to work with both domestic and international distributors, as well as providing guidance to our customer service/sales staff.”
Schultze joins EDI as Document Control Specialist
EDI is pleased to announce the addition of Sara Schultze to the staff as document control specialist. Schultze comes to the company with a combination of science and marketing education with extensive professional experience working with cross-functional teams and projects. She worked previously as a research assistant in toxicology and structured genomics laboratories, including as a genetics teaching assistant.
“Sara’s background will be a great advantage as we further develop our document control procedures,” says Scott Clarke, Quality Assurance Manager. “We are excited to have her join the EDI team.”
EDI welcomes Frankamp to Customer Service/Sales
Paul Frankamp recently joined Express Diagnostics as a customer service/inside sales representative. He comes to EDI with over 30 years of sales experience in the petroleum and communications industries. Part of Frankamp’s duties will be to maintain communication with the varied industries in which Express Diagnostics markets drug screening devices and services.
“Paul has been a welcome addition to our Customer Service/Sales staff,” says Nick Skaden, Sales Manager. “We look forward to both benefiting and learning from his extensive sales and customer service experience.”
QED Saliva Alcohol Test now available through Express Diagnostics
The QED A150 Saliva Alcohol Test is now in stock in 10-count boxes. Take advantage of the popular features of the QED A150:
- DOT approved and CLIA waived
- Quantitative results in 2 to 5 minutes
- Reads like a thermometer
- Long shelf life
The QED A150 Saliva Alcohol Test can be used as an accurate screen in place of blood or breath tests. In clinical trials, saliva alcohol levels measured by the QED demonstrated high correlation to blood analyzed by gas chromatography (r = 0.98). The QED Saliva Alcohol Test has a quantitative range of 0-145 mg/dL (0.0% - 0.145% BAC).
New Rx-Check Pain Management Drug Testing program announced
Express Diagnostics has partnered with Phamatech Laboratories to create a comprehensive drug testing program to assist physicians in assessing the pharmacological status of their patients. The Rx-Check™ Pain Management Drug Testing program combines on-site testing of the DrugCheck® Waive™ RT with the SAMHSA and CLIA certified laboratory services of Phamatech Laboratories. Physicians and clinics utilizing the program will benefit from instant 12-panel drug screenings coupled with rapid turn-around of clinical laboratory results for thorough, effective medication monitoring.
The DrugCheck Waive RT on-site cup is designed with several features unique to CLIA-waived drugs of abuse devices, including a built-in results ready indicator that indicates when to read presumptive positive results. It is also the only CLIA-waived cup with 500 ng/mL cutoffs for methamphetamine and MDMA (3,4-methylenedioxymethamphetamine) and 200 ng/mL cutoffs for benzodiazepines and barbiturates, delivering greater sensitivity than standard CLIA-waived screening devices. The Waive RT is made in the U.S.
Phamatech Laboratories provides clients of the program with screening customization options and complex personalized profiles. Classification and quantification of drugs through GC/MS or LC-MS/MS confirmation is available at the lowest validated cutoff levels. Three comprehensive profiles allow physicians to customize drug urine screens to their patients’ needs, including illicit drugs of abuse and most opioids. Within their state-of-the-art facility, Phamatech toxicologists provide FAA, FHWA, FMCSA, FTA, NHTSA and PHMSA testing while adhering to a forensically strict chain of custody.
EDI hosts Quality Assurance intern
Express Diagnostics recently hosted a Quality Assurance intern. Kinnedy Durham, of Clinton, LA, “shadowed” QA personnel for four days at EDI’s facility learning about the company’s processes for quality assurance/quality control. Kinnedy is an “A” student at East Feliciana High School and is interested in pursuing a career in biochemistry, specifically in the field of diabetes research. She has been an insulin-dependent juvenile diabetic for over 10 years. Kinnedy is an avid reader and researcher, and has been interested in all forms of biology-related information since early childhood. She also is involved in Junior Reserve Officers’ Training Corps (JROTC).
“It was a pleasure to have Kinnedy in our facility last week,” says Scott Clarke, Quality Assurance Manager. “She was able to witness how our product is built, how it operates and the testing it undergoes. It was our goal that Kinnedy would gain a greater understanding of DrugCheck products and how this technology is applied to everyday life. We appreciate the opportunity to influence a young woman in a positive way and give her valuable insight into what we do at Express Diagnostics.”
Express Diagnostics announces new Business Development Manager
Express Diagnostics Int’l (EDI), manufacturer of DrugCheck brand testing devices, is excited to announce that Nick Skaden has been promoted to Business Development Manager.
“Nick will continue to sell and promote EDI and its products, but on a larger scale,” said Paul Johnson, CEO of Express Diagnostics. “He will be working directly with established distributors, both domestic and international, but with an emphasis on cultivating new distributor relationships both here and abroad. Nick’s role will include managing the Sales Department and its staff as it expands over the next 30 days and beyond.”
Skaden graduated from Blue Earth Area High School in 2004. He obtained his BA in Communication Studies from Minnesota State University, Mankato in 2009. His career at EDI began in November 2009 as Inside Sales Representative.
“I look forward to the new challenges ahead of me and to supporting EDI as we look to the future,” said Skaden. “I will be actively exploring new markets for our devices and anticipate working more closely with our customers.”
Express Diagnostics revises website
Drugcheck.com has been revised to improve access to the International Products and Resources sections of the website. Visitors to the site may now access “Frequently Asked Questions” and “Customer Support” through the “Resources” section. In addition, the main navigation menu now includes a link to information on SAMHSA and CLIA certified drugs of abuse laboratory services available through Express Diagnostics.
DrugCheck Waive™ RT: Only CLIA waived DOA cup with BZO200, MET500
The new DrugCheck Waive RT CLIA-waived cup contains benzodiazepine at 200 ng/mL and methamphetamine at 500 ng/mL. No other CLIA waived drug screening cup offers these cutoffs. The Waive RT also includes a Result Ready timer that tells the operator when to read presumptive positive results. Simply add the specimen and watch for color in the window. LEARN MORE
ABC News recognizes Express Diagnostics - DrugCheck® on its Made in America website
ABC News recently included Express Diagnostics Int’l (EDI), manufacturer of DrugCheck, on its Made in America website. The site highlights American companies that are manufacturing products for sale internationally and providing jobs in the U.S.
Visitors to the ABC News Made in America site: Click on the star in southern Minnesota (Blue Earth). LEARN MORE
Express Diagnostics completes phase one of facility expansion
Express Diagnostics Int’l (EDI), manufacturer of DrugCheck onsite drugs of abuse testing devices, recently completed phase one of a facility expansion to accommodate continued growth of the organization. The 8,500 sq. ft. addition provides offices and work areas for 15 staff members, dedicated space for conference, media, maintenance, and employee break rooms, as well as additional warehousing.
Company growth over the last year put increasing demands on available area for office staff. “The new office expansion allows us to better meet the needs of our customers by providing space for our growing customer service and sales staff,” says Karen Huntington, office manager at EDI. “It also makes more efficient use of space by locating various department staff closer to one another.”
Phase two of the construction project will include a 1,500 sq. ft. expansion of a humidity-controlled production room. The larger “dry room” will house additional production lines required for new DrugCheck® devices scheduled to launch over the next three to six months.
Express Diagnostics welcomes new director of operations
Express Diagnostics Int’l (EDI), manufacturer of DrugCheck drugs of abuse screening devices, is pleased to welcome Gary Jueneman as director of operations. Jueneman comes to EDI with over 30 years of experience in warehousing and logistics operations within the food industry.
“We’re excited to have Gary join our team,” said Paul Johnson, CEO of Express Diagnostics. “His breadth of experience in logistics and warehousing, as well as his customer-centered approach to operations, will serve us well as we continue to grow both our manufacturing process and distribution partnerships.”
In his new role as director of operations, Jueneman will oversee the day-to-day activities of EDI’s customer service, production, warehousing, and shipping departments. With extensive knowledge of inventory, logistics, and complete supply chain management, Jueneman will be tasked with further improving efficiencies throughout EDI.
Product Catalog page updated
The Product Catalog page on the DrugCheck website has been updated to reflect items listed on the current Product List (U.S.), which are considered stock items. Other custom configurations are available at minimum order quantities of 200 per item number. Products available for export can be found on the International Products page.
PregCheck™ early pregnancy test now available
The latest addition to EDI’s expanding product catalog, the PregCheck+ early pregnancy test, is now available. PregCheck™ is available in urine and serum/urine pipette cassette format and is CLIA waived. Visit the PregCheck™ page of the website or contact your customer service representative for more information.
EDI launches extensive update to website
Express Diagnostics is pleased to announce a significant revision to its website — drugcheck.com. The site now provides information on EDI’s expanded product line, including AlcoCheck™ and HealthCheck™ brands. Also available on the new site is a page dedicated to Customer Support. Questions submitted through the Customer Support page are routed directly to customer service representatives to ensure quick replies.
New CLIA-waived drugs of abuse testing devices
DrugCheck Waive™ CLIA-waived screens provide fast, accurate, easy-to-read results in minutes. Two dip test formats are available in 12-panel (two-sided) and single-panel screening devices. Our operator-activated cup detects 12 drugs of abuse (OPI 2000 cutoff) and five adulterants (OX, SG, CR, pH, NI).
- CLIA-waived cup and dips
- Waived for up to 12 drugs
- Lab accuracy
- Results in 5 minutes
- FDA 510K cleared
EDI introduces new adulterant configurations
Adulterant (specimen validity) testing
Adulteration results are obtained by direct comparison of the reacted strips with color blocks on the charts included in each box of devices. Testing in 3- or 6-panels is offered in the following adulterants:
- pH
- Specific gravity (SG)
- Oxidants (OX)
- Creatinine (CR)
- Nitrite (NI)
- Glutaraldehyde (GL)
Strips contain pH, SG, OX and CR, NI, GL. The adulterant color chart is now combined with the alcohol color chart in a convenient fold-able card that users can stand up for easy viewing. The back of the card includes alcohol and adulterant testing information.
New Single-Drug Dip Test devices screen for 14 individual drugs or alcohol
Product features and benefits:
- Detection of one of 14 individual drugs or alcohol*
- 100% made in the U.S.A.
- Window for results
- End cap covers dipped portion of test strip
- Photocopy or scan results
- OMS Ready™
- Results in 5 minutes
* Urine alcohol test for international distribution only
DrugCheck Online Management System™ implemented
Drug test administrators can now manage multiple aspects of their onsite drug testing program, including testing procedures, results management, and training with the DrugCheck Online Management System (OMS). As the most powerful tool in the DrugCheck® OMS™, the Results Management section of the web-based software allows users to upload scanned results from NxScan and Dip Test devices, record donor results, and refer back to past records on each drug test entered into the system. Administrators interested in reviewing the DrugCheck OMS can contact their DrugCheck distributor for more information.
Ready for a quick dip?
In September 2008 Express Diagnostics introduced the next generation of its Dip Drug Test, with a new flood-proof label. The DrugCheck Dip Drug Test provides simultaneous detection of up to 14 drugs, adulterants and/or alcohol and allows users to photocopy or scan results for a permanent record.
Health Canada License obtained
The government of Canada recently issued Express Diagnostics a license (#77258) authorizing distribution in the country. With licensure under the name DrugCheck® Onsite Multi-Drug Drug of Abuse Test (urine), EDI is now able to market its products throughout Canada. For more information, feel free to contact EDI or visit the Health Canada website.
Copy/scan results for permanent record with
the new NxScan OnSite Drug Test Cup
Express Diagnostics is pleased to announce the next generation of its onsite drug testing cup—the DrugCheck NxScan OnSite cup:
- Photocopy or scan results for permanent record (template included)
- Cup lies flat on copier or scanner for clear copying or scanning
- Results in 5 minutes
- Lab accuracy
- Simultaneous detection of up to 14 drugs, adulterants and/or alcohol
- One drug per color-coded strip
- Easy interpretation and better sensitivity
For more information, email us at info@drugcheck.com.
ISO 13485:2003
We are pleased to announce our certification with ISO 13485:2003, the international standard for quality in medical devices and services.
As defined by the International Organization for Standardization:
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
CE Certification
“CE” is an abbreviation for the French: “Conformité Européne.” Inclusion of CE marking indicates conformity with respect to European Union (EU) distribution standards. Certification allows manufacturers to freely distribute products throughout the 27-member EU market of nearly 500 million people.