Express Diagnostics News
Express Diagnostics welcomes new controller
Express Diagnostics Int’l, Inc. (EDI) is pleased to welcome Dave Klabunde as controller. In the position, Klabunde will direct EDI’s finance department, as well as serve an advisory role in company-wide financial and business decisions.
Klabunde previously served as financial analyst/controller for Fairmont Orthopedics & Sports Medicine and, prior to that, as program-operations manager at Youth Services International, Inc. (YSI), a residential treatment facility for juveniles. While at YSI, Klabunde was involved in all aspects of the organization’s operations, including operational planning and direction of cross-functional departments, financial planning, and leading human resources information systems and information technology initiatives.
“We are very pleased to have Dave join our team as controller,” says Paul Johnson, CEO of Express Diagnostics. “His extensive background in business and financial planning, as well as his broad operations experience, will be a great asset in clarifying decision points as we progress as a company. Dave will be instrumental in helping management direct our tremendous growth.”
Klabunde started with EDI in early October and looks forward to ‘getting up to speed’ with the various tasks and departments he will be involved with as controller. “I like the business side of controller duties, because numbers don’t lie,” he says. “My role will be to look forward and around what’s going on to allow management to make decisions on the overall direction of the organization.”
Originally from Nebraska, Klabunde has lived in the Blue Earth, Minn., area since 1997. He and his wife, Karen, have three children: Ryanne, 15; Taylor and Matthew, both 8.
Express Diagnostics named to the Inc. 5000 list of fastest-growing companies
Inc. magazine today named Express Diagnostics Int’l, Inc. (EDI) to its annual Inc. 5000 list of the fastest-growing companies in the U.S., with the position of 2,846 on the 2013 Inc. 5000. EDI manufactures and distributes DrugCheck® onsite drugs of abuse tests, as well as a growing line of rapid alcohol screening and health diagnostics devices.
“For 32 years, Inc. has welcomed the fastest-growing private companies in America into a very exclusive club,” says Eric Schurenberg, Inc. editor in chief. “The Inc. 5000 was harder to get into this year than ever in its history. The median company on the list increased sales more than 140 percent since the start of 2010, while the average honoree grew a mind-boggling 468 percent. Those are results most companies could only dream of in the economy of the past three years.”
With its inclusion as an Inc. 5000 honoree, Express Diagnostics Int’l now shares a pedigree with well-known companies such as Intuit, Zappos, Under Armour, Microsoft, Timberland, Pandora, Patagonia, Oracle, and scores of other alumni.
“Express Diagnostics is thrilled to be named to the Inc. 5000,” says Paul Johnson, CEO of EDI. “This honor is the result of sustained dedication of our personnel and loyal customers, as well as the continued commitment of our vendor partners to satisfy the requirements of our ever-increasing volumes. Our substantial growth, particularly over the last three years, truly has been a team effort and EDI management wants to recognize all of those who made this Inc. 5000 honor possible. We look forward to even greater growth in the future with the dedicated, collaborative team that we’ve assembled.”
Express Diagnostics is based in Blue Earth, Minn., and has distribution partners in more than 60 countries. Founded in 2004, EDI also has company representatives in California, Colorado, Massachusetts, Texas, and Strasbourg, France.
About the Inc. 5000
The 2013 Inc. 500 | 5000 is ranked according to percentage revenue growth when comparing 2009 to 2012. To qualify, companies must have been founded and generating revenue by March 31, 2009. They had to be U.S.-based, privately held, for profit, and independent – not subsidiaries or divisions of other companies – as of December 31, 2012. The minimum revenue required for 2009 is $100,000 and $2 million for 2012. Companies on the Inc. 5000 are featured in the magazine’s September issue, and online at the 2013 Inc. 5000 web page.
Express Diagnostics introduces new products and expanded catalog of drug tests at the 2013 AACC Clinical Lab Expo
Express Diagnostics Int’l looks forward to exhibiting at the American Association for Clinical Chemistry (AACC) Clinical Lab Expo July 30 through August 1 in Houston, Texas. In addition to the launch of a number of new products, EDI’s vice president of research and development will be presenting an abstract on the company’s new onsite test for hematocrit.
Products being introduced include an expanded catalog of 39 urine drug tests and detection levels – or cutoffs – for the international market, the DrugCheck semi-quantitative test for gamma-hydroxybutyric acid (GHB) in lateral-flow format, an innovative urine collection aid, two over-the-counter cleared disposable tests: the AlcoCheck® Breath Alcohol Screen and the Urinary Tract Infection test strip, and a new onsite test reader system in development.
The company’s expanded presence at the Clinical Lab Expo will include an abstract presentation by Steve Tyrrell, vice president of R&D at Express Diagnostics. Tyrrell will present “Preclinical development of a disposable, instrument-free device for measuring hematocrit” at 11:20 a.m., Tuesday, July 30, as part of the AACC OEM Lecture Series. The AnemiaCheck™ POC Quantitative Hematocrit Test is an entirely self-contained, disposable device designed to measure hematocrit levels with no instrumentation. The device is not currently available in the U.S. and will be available for export in the fourth quarter of 2013.
“We are very excited about the breadth and number of new products Express Diagnostics is introducing this year at AACC and we’re proud of our R&D team for the development of a revolutionary reader system for onsite testing devices that we’ll be demonstrating at our booth,” says Paul Johnson, CEO. “These product advancements, coupled with our significant growth over the past year, warranted our largest presence ever at the Clinical Lab Expo with a 10 foot by 20 foot exhibit space.”
The new urine drug tests and cutoffs offered under EDI’s DrugCheck brand bring the total number of tests available for export to 39. The new test strips will be of particular interest to international customers where several of the focus drugs have become much more prevalent in recent years. In addition to previously available tests, DrugCheck onsite cups and dip tests can now screen for clonazepam, EDDP, fentanyl, GHB, methadone (200 ng/mL), tramadol, and 16 different synthetic marijuana/cannabis (K2) compounds.
DrugCheck urine cups and dip tests are FDA 510(k) cleared for 17 drugs of abuse. The additional 22 drugs and cutoffs included in the expanded catalog of custom drug tests and cutoffs are available for export or forensic use only.
Visitors to the 2013 AACC Clinical Lab Expo can find Express Diagnostics Int’l at booth 1835/1837.
Express Diagnostics to raise funds for American Cancer Society during Blue Earth’s Giant Days parade
Express Diagnostics Int’l, manufacturer of DrugCheck® on-site drugs of abuse tests, is excited to be participating in the Giant Days parade Saturday, July 13, in Blue Earth, Minn. This is the second year the Blue Earth-based company has participated in the parade, which this year will include EDI employees requesting donations for the American Cancer Society Relay For Life.
“Express Diagnostics is proud to be part of the Blue Earth community and we welcome the opportunity to support Giant Days and, in turn, be able to raise funds for such a worthy cause as the American Cancer Society Relay For Life,” says Paul Johnson, CEO of Express Diagnostics. “EDI staff will be walking the parade route asking for donations that will go towards fundraising for the company’s 2013 Relay For Life team to help battle this disease that affects so many families.”
The 2013 Faribault County Relay For Life will be held August 9-10 at the Faribault County Fairgrounds in Blue Earth. Anyone interested in donating to the Express Diagnostics Relay For Life team can visit the EDI team page at edi-relayforlife.org.
Giant Days festivities begin Thursday evening, July 11, with the first of several performances of “Shrek the Musical” at Blue Earth Area High School, followed by “Party with the Giant” on Friday, July 12, at Giant Park with food vendors, games, music, and fireworks at dusk. In addition to the parade, Saturday events include craft, art, and bake sales, a fun run, and a street dance. The parade begins at 5 p.m. at Wilson Football Field and proceeds through downtown Blue Earth on Main Street.
For complete Giant Days details visit the Blue Earth Chamber of Commerce website at blueearthchamber.com. It’s going to be huge!
Express Diagnostics’ DrugCheck® on-site test cup receives Health Canada Class III medical device license
Express Diagnostics Int’l, manufacturer of DrugCheck® on-site drugs of abuse tests, today announced that it has received Class III medical device license approval from Health Canada to market and sell its DrugCheck® NxStep Onsite Drug Screen Cup in Canada. Class III licensure allows use of the rapid screening device in near-patient settings, such as physicians’ offices.
The DrugCheck NxStep Onsite Drug Screen Cup received a Health Canada Class III license for 24 different drugs and detection levels, or cutoffs. In addition to tests typically included in drugs of abuse urine screens, such as amphetamine, cocaine, opiates, and marijuana, the Drug Screen Cup is also licensed to screen for drugs not often cleared for Health Canada Class III, including cotinine (nicotine), EDDP, K2/spice (synthetic marijuana), ketamine, and alcohol.
“We are very pleased to receive Health Canada Class III licensure for our NxStep Onsite Drug Screen Cup,” says Paul Johnson, CEO of Express Diagnostics. “Canada Class III status will allow for wider distribution of our U.S.-made DrugCheck product, but more importantly, the expansive list of drugs and cutoffs licensed for use in our Drug Screen Cup will deliver greater testing flexibility to administrators and healthcare providers throughout Canada to help improve screening and treatment for employees and patients nationwide.”
While the DrugCheck NxStep Onsite Drug Screen Cup is now licensed by Health Canada for Class III use in Canada, the device has been FDA 510(k) cleared-to-market for 17 drugs and detection levels (cutoffs) in the U.S. for several years. FDA 510(k) clearance allows the NxStep Onsite Drug Screen Cup to be used in the U.S. for pre-employment, random, and reasonable cause screening, as well as corrections, clinical, and hospital settings. The additional seven drugs and cutoffs licensed by Health Canada for inclusion in the Drug Screen Cup are currently available in the U.S. as forensic use.
The DrugCheck NxStep Onsite Drug Screen Cup rapid test provides results in five minutes and can screen for up to 15 drugs of abuse simultaneously. It combines a collection cup and testing device for rapid results, convenience, and accuracy. The self-contained urinalysis screening cup detects the presence of drug metabolites in minutes, using Substance Abuse and Mental Health Services Administration (SAMHSA) cutoff levels. Simply collect urine into the cup, remove the privacy label, and read the results in five minutes. Presumptive positive results are confirmed at a laboratory.
As an ISO 13485:2003-certified manufacturer, Express Diagnostics met the requirement of Health Canada Medical Devices Regulations that all Class III medical devices be designed and manufactured under ISO standards for medical device manufacturing.
Australian distributor of Express Diagnostics signs sponsorship agreement with V8 Supercar team
Express Diagnostics Int’l (EDI) and Royal Medical Supplies Pty Ltd are pleased to announce a sponsorship agreement with Erebus Motorsport V8. Royal Medical is the Australian and New Zealand distributor of DrugCheck® onsite testing devices, manufactured by EDI. The Erebus Motorsport V8 Supercar Team participated in the Austin 400 May 17-19 in Austin, Texas.
Royal Medical Supplies has entered into an agreement that involves each car of the Erebus Motorsport team displaying the Royal Medical name and logo in Australian racing events. Erebus owns and races three Mercedes-Benz E63 AMG V8 Supercars in the Australian V8 Supercar series — the Australian equivalent to the American NASCAR® series. For races held in the U.S., the team’s cars will also display the DrugCheck logo.
“We’re very excited about partnering with Erebus Motorsport, which races the Mercedes-Benz AMG, a new make of race car for the V8 Supercar series,” says Gavin Holland, director of Royal Medical Supplies. “This motor racing championship appeals to a high proportion of Australians and New Zealanders and our target customers will be able to enjoy some of the on-track and off-track benefits resulting from this arrangement. The cars competing in the championship held in Austin, Texas, displayed the DrugCheck logo as well, providing additional media and on-track exposure for the brand.”
While sports team and event sponsorship is new to Express Diagnostics, the company welcomes Royal Medical’s efforts to raise the visibility of the DrugCheck brand. “We value our partnership with Royal Medical Supplies and appreciate Gavin’s commitment to promoting this U.S.-made product,” says Rich Strasser, COO of Express Diagnostics. “It was exciting to see the DrugCheck logo on the Erebus Motorsport cars during the Austin 400. We’d like to thank Royal Medical both for their sponsorship of the team and their continued support.”
Erebus Motorsport next races in the Skycity Triple Crown June 14-16 in Darwin, Australia.
IntraMed Diagnostics announces two senior-level additions
Kingston to serve as director of engineering and manufacturing
IntraMed Diagnostics, LLC, a subsidiary of Express Diagnostics Int’l (EDI), is pleased to welcome Dean Kingston as director of engineering and manufacturing and Barry Vant-Hull, Ph.D., as senior software engineer.
Kingston previously served as engineering manager and senior product development engineer for Eveia Medical, Inc. While with Eveia Medical, he led the design, research, and development of the ArcFlow™ Point-of-Care platform, designed to be implemented in a variety of quantitative tests, including devices intended for testing coagulation rates (blood thinners), C-reactive protein (CRP), HbA1c, and several other potential clinical diagnostics applications.
Eveia’s patent pending cell quantitation technology will also be incorporated into EDI’s AnemiaCheck™ POC Quantitative Hematocrit Test, which will be available for export in Q3 2013. IntraMed Diagnostics recently acquired an option for future development of Eveia Medical’s complete portfolio of point-of-care clinical diagnostic testing assets.
Kingston began his career at B-Ten Systems, Inc., designing robotic assembly machines for medical industries. The company specializes in custom automation, robotics, and machine design manufacturing. As vice president of engineering, Kingston led many high-profile projects, implemented Pro/Engineer® design software with Pro/Intralink® data storage, and established a quality assurance system, design controls, and design standards. He later joined the executive team of Bolt Industries, Inc., where he served as general manager of the company’s Minnesota facility.
“Dean will be key to bringing our innovative testing devices to market. His design and manufacturing skills will help to ensure robust test performance in the field, while maintaining designs that can be manufactured on efficient, fully-automated lines,” says Steve Tyrrell, EDI and IntraMed vice president of research and development. “Having been a part of the team since the inception of the technologies, Dean’s experience will be important as we develop and introduce additional applications to market.”
Kingston is a graduate of Colorado State University, where he earned a degree in mechanical engineering with an emphasis in product design and manufacturing.
Vant-Hull directing integration of software with onsite testing platforms
Dr. Vant-Hull is the former director of research and development at Eveia Medical. During his tenure he was responsible for developing hardware and software to support a new in vitro diagnostics platform for clinical laboratories. Additionally, he has an extensive background in software development, including laboratory automation, high-throughput screening robotic workstations, and development of a tiered Java-based framework for integrating third-party and in-house devices for automating laboratory protocols.
“Dr. Vant-Hull brings the valuable combination of strong software development skills and a sound understanding of science and mathematics. These skills will enable us to develop innovative software applications that are easy to use, while applying advanced algorithms that enhance the performance of associated testing devices,” says Tyrrell. “We look forward to benefitting from Dr. Vant-Hull’s extensive background in biochemistry, engineering, and software development as we further develop our onsite diagnostic technologies.”
During his postdoctoral research at the University of Colorado, Dr. Vant-Hull assisted in biochemical engineering and molecular biology while studying high-density hybridoma cultures in bioreactors. He holds a doctorate in biochemical engineering and a master’s of science from the University of Colorado.
Both Kingston and Vant-Hull are based out of the IntraMed Diagnostics facility in Boulder, Colo.
About IntraMed Diagnostics, LLC
IntraMed Diagnostics, LLC, a subsidiary of Express Diagnostics Int’l, Inc., was established to increase market penetration in the point-of-care testing market, a rapidly expanding multi-billion dollar industry. The company conducts engineering, research, and development for onsite in vitro diagnostic drugs of abuse screening and health diagnostics applications. Learn more at intrameddx.com.
Express Diagnostics partners with Project GHB to increase awareness of effects of GHB
New DrugCheck® onsite GHB Single Test central to partnership’s goals
Express Diagnostics Int’l today announced a partnership with Project GHB to increase awareness of the dangerous effects of the drug GHB (gamma hydroxybutyrate). Under the partnership, and as part of the organization’s educational outreach, Project GHB will include information on the new DrugCheck GHB Single Test, which detects the drug in biological samples. Express Diagnostics will provide support material and donate a portion of GHB Single Test sales to Project GHB back to the 501(c)(3) non-profit organization. The donated funds will help further the group’s mission of increasing awareness of the dangerous effects of GHB.
“Over the course of my 20-year law enforcement career, there were several instances where I encountered GHB and I was always frustrated that we (law enforcement) had no access to a simple test for the drug,” says Rich Strasser, COO of Express Diagnostics. “GHB has been referred to as the ‘invisible drug’ because of its difficulty to detect. We are very excited about our partnership with Project GHB and our ability to finally offer a reliable instant onsite test for GHB.”
While GHB has garnered news coverage as a “rape drug,” its increased use among adolescents and young adults, athletes, and even the elderly is also a concern. Nationally, more people have overdosed on GHB in the last several years than on MDMA (Ecstasy). The fact that GHB is only detectable in a person’s blood for four hours and in urine for 12 hours — and few medical and forensic staff test for its presence — makes it likely that the actual number of GHB overdoses is much higher than reported.
GHB is also becoming more prevalent in drunk/drugged driving arrests, presenting a particular problem due to lack of awareness among law enforcement and the difficulty, until recently, in obtaining appropriate testing. People on GHB may present to authorities with symptoms ranging from a profound coma to hallucinations or wild, bizarre behavior that are often not recognized and may be mistakenly attributed solely to alcohol consumption. GHB, also known as sodium oxybate, is prescribed as Xyrem® for narcolepsy and cataplexy.
The new DrugCheck GHB Single Test, the only onsite test for GHB, provides semi-quantitative results in five minutes. The simple procedure involves dipping the test strip into the specimen for five seconds and then comparing color changes in the reactive pad to a color chart provided on the product pouch. The urinalysis test strip is currently available in dip format.
“This is a leap forward for law enforcement handling impaired driving cases, and even death cases,” says Trinka Porrata, president of Project GHB. “Traditionally, GHB has been ignored in testing due to lack of knowledge and because testing required a sample to be sent out for definitive testing and required a separate expensive test. The quick, inexpensive DrugCheck GHB Single Test will enable screening for GHB onsite and should improve the odds of detecting this elusive drug.”
Adds Strasser, “Trinka has worked relentlessly to educate people about the dangers of this addictive drug and we are very pleased that we can assist her and Project GHB in furthering this important cause.”
About Project GHB
In addition to researching and cataloging the latest GHB information, Project GHB provides referrals, basic counseling, and intervention through a helpline hosted on their website (projectghb.org). The Project GHB helpline has assisted more than 3,500 addicts and their families throughout the U.S. and more than 20 countries.
Project GHB’s board consists of three survivors — parents who have lost children to GHB — plus one member from law enforcement and one substance abuse counseling professional. Porrata is a 25-year veteran of the Los Angeles Police Department (LAPD) where she worked in narcotics, as well as sex crimes and child abuse. Now retired from the LAPD, she is an internationally recognized expert on the so-called “club drugs” of abuse, including GHB. She provides instruction, legislative support and expert testimony regarding various current drug issues, drug-facilitated sexual assaults, and the rave phenomenon. Porrata has testified before a Congressional committee, the California state legislature, and the Nevada Pharmacy Board about the dangers of GHB and other debilitating drugs.
The mission of Project GHB is to educate the public about the dangers of GHB and to provide a forum for those who have been sexually assaulted after being given the drug or lost a loved one to GHB, and to assist those who are addicted to the drug. Project GHB was founded in 1998 by the parents of 27-year-old Caleb Shortridge, who died from a GHB overdose. Learn more at projectghb.org.
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