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PTS Diagnostics Announces 14 New US and International Patents

PTS Diagnostics Announces 14 New US and International Patents

Proprietary technologies drive innovation in point-of-care testing

Indianapolis – Feb. 25, 2015 – PTS Diagnostics, the U.S.-based manufacturer of both the CardioChek® brand and the A1CNow® family of point-of-care diagnostic products, has been granted 4 new U.S. patents and 10 new patents from Canada, Europe, Germany, India, Korea, and Mexico in just the last 18 months. Since mid-2013, PTS Diagnostics was awarded 5 patents related to its CardioChek test strips, 8 for its A1CNow+ system and one for a new test strip that can test multiple blood chemistries at the same time.

“We continue to develop new and alternative innovations for our CardioChek test strip technology in the US and continue to be granted patents around the globe as we expand distribution of our A1CNow+ system to additional countries,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “This technology ensures we deliver accurate and precise lipid, glucose and A1C testing and monitoring.”

In approximately the last 18 months, PTS Diagnostics was granted these new patents:

  • United States: #8,460,539; #8,465,696; #8,642,320; #8,865,089
  • Canada: #2,654,292
  • Europe: #1 474 692; #1 725 650; #2 221 621
  • Germany: #112,012,000,32
  • Korea: #10-1,324,375, #10-1,347,472
  • India: #258,142; #257,235
  • Mexico: #315,864

    • PTS Diagnostics currently holds 91 U.S. and international patents and has 86 pending patent applications.

    “As we look to the future, we are anticipating the needs of our customers and are working diligently to create next-generation technology to expand the testing and services we provide,” said Huffstodt. “These new patents, combined with our pending applications, will fuel PTS Diagnostics’ growth in the future. We continue to have a robust pipeline of new innovation and look forward to the next year and beyond.”

    PTS Diagnostics’ products are sold in more than 120 countries and its CardioChek analyzers have screened more than 120 million people worldwide. In addition, sales of its A1CNow System surpassed 1 million tests in just 8 months after the company began manufacturing the A1C monitoring device.

    PTS Diagnostics’ handheld, highly-accurate, fast, and economical diagnostic devices empower the medical community to quickly measure HbA1c and glucose, and generate a lipid (cholesterol) profile, all at the point of care.

    PTS Diagnostics’ portfolio includes the following systems:

  •  CardioChek professional analyzers address the connection between heart attack, stroke, and diabetes by providing on-site lipid panel (total cholesterol, HDL cholesterol, and triglycerides) screening results in as little as 90 seconds and can also measure glucose. CardioChek professional analyzers calculate LDL cholesterol, the TC/HDL ratio, the LDL/HDL ratio, and non-HDL cholesterol.
  •  The A1CNow+ system provides healthcare professionals with a fast, easy, and accurate method of obtaining HbA1c results while the patient is in the exam room. In just five minutes, clinicians have information to provide an immediate consultation with a patient. The A1CNow+ system is critical to diabetes management and is fully reimbursable.

    • About PTS Diagnostics – PTS Diagnostics is a global provider of point-of-care diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, and markets products for distribution in over 120 countries around the world. The company has sales offices in Europe, Latin America, and the Pacific Rim. PTS Diagnostics’ products include both the CardioChek systems and A1CNow systems.

    All trademarks used or mentioned in this release are protected by law.

    For more information, visit www.ptsdiagnostics.com or contact Tom Wiser at +1-317-870-5610.

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    PTS Diagnostics Introduces Secure Cloud-Based Solution Enhancing Corporate Wellness Programs and Improving Health Screeners' Productivity

    PTS Diagnostics Introduces Secure Cloud-Based Solution Enhancing Corporate Wellness Programs and Improving Health Screeners’ Productivity

    PTS Connect™ Wellness Solution is an online tool that digitizes data from screening events and promotes employee engagement in corporate wellness programs

    Indianapolis, March 10, 2015 – PTS Diagnostics, the U.S.-based manufacturer of both the CardioChek® brand and the A1CNow® family of point-of-care diagnostic products, announces the launch of the PTS Connect™ Wellness Solution. This secure cloud-based solution will empower health screening companies to screen more individuals faster and corporate wellness programs to improve outcomes by encouraging participants to monitor and track activity and progress online. In addition, it enables population health management by targeting wellness communication and aggregating data for at-risk individuals.

    In short, the PTS Connect Wellness Solution provides an opportunity to improve productivity, participant engagement and data analysis among organizations that manage wellness screenings and wellness programs.

    “The PTS Connect Wellness Solution is the complete Population Health Management tool. As a software solution for screening and wellness programs, the new online tool meets the needs of customers with a variety of goals,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “Some customers may simply want to automate the acquisition of biometric results, provide immediate screening reports to participants
    and aggregate data. Others may want to grant online access to participants after the screening event, providing online education and enabling targeted wellness messaging. This flexible solution allows customers to grow their wellness platform over time to meet changing needs.”

    For health screeners, the software is capable of automated upload of biometric information from a CardioChek lipid and glucose analyzer, and from a weight scale, blood pressure monitor and pedometer. The biometric data is stored securely and can be synced instantaneously with a participant’s online wellness account.

    For corporate wellness programs, PTS Connect Wellness Solution offers a turnkey range of online tools and resources supporting healthy lifestyle change. PTS Connect offers a personal health assessment that produces wellness education based on individual needs. In addition, users can track and monitor physical activity over time. Educational offerings include quizzes, calculators, self-assessments and decision guides.

    “Our new platform was designed for screeners and corporate wellness programs,” said Huffstodt. “We have taken the entire health management continuum and created an online software solution to make screening and running a corporate wellness program easy. We are excited to begin offering these solutions via our global distribution network.”

    In addition to PTS Connect Wellness Solution, PTS Diagnostics’ portfolio includes the following systems:

  • CardioChek professional analyzers address the connection between heart attack, stroke, and diabetes by providing on-site lipid panel (total cholesterol, HDL cholesterol, and triglycerides) screening results in as little as 90 seconds and can also measure glucose. CardioChek professional analyzers calculate LDL cholesterol, the TC/HDL ratio, the LDL/HDL ratio, and non-HDL cholesterol.
  • The A1CNow+ system provides healthcare professionals with a fast, easy, and accurate method of obtaining HbA1c results while the patient is in the exam room. In just five minutes, clinicians have information to provide an immediate consultation with a patient. The A1CNow+ system is critical to diabetes management and is fully reimbursable.

    • About PTS Diagnostics – PTS Diagnostics is a global provider of point-of-care diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, and markets products for distribution in over 120 countries around the world. The company has sales offices in Europe, Latin America, and the Pacific Rim. PTS Diagnostics’ products include both the CardioChek systems
    and A1CNow systems.

    All trademarks used or mentioned in this release are protected by law.

    For more information, visit www.ptsdiagnostics.com or contact Tom Wiser at +1-317-870-5610.

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    PTS Diagnostics Named to Inc. Magazine's 2015 List of the 5,000 Fastest Growing Private Companies

    PTS Diagnostics Named to Inc. Magazine’s 2015 List of the 5,000 Fastest Growing Private Companies

    Global medical device manufacturer selected for fifth time to prestigious list based on three-year sales growth of 137%

    Indianapolis, IN – August 17, 2015 – PTS Diagnostics, the U.S.-based manufacturer of both the CardioChek® brand and the A1CNow® family of point-of-care diagnostic products, was ranked as one of the nation’s fastest-growing private companies by Inc. magazine. The magazine’s 34th annual “Inc. 5000 list” ranked PTS Diagnostics as the 2,684th fastest growing company in the United States.

    Last year, PTS Diagnostics earned its place on the list with 80 percent growth over the previous three years. PTS Diagnostics continued to increase sales by earning 137 percent growth over the past three years in the 2015 list.

    “Our fast, easy, portable and accurate point-of-care diagnostic devices test people around the world for multiple key disease states, including high cholesterol and diabetes, with just a simple fingerstick,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “We have also just expanded our portfolio of products to include the PTS Detect tobacco-detection system, the only point-of-care device that offers quantitative results from a fingerstick.”

    In addition, the company recently launched the PTS Pod collection system further innovating its line of point-of-care testing options. To complement its line of diagnostic devices, in early 2015 the company introduced PTS Diagnostics™ capillary tubes, and the PTS Connect™ wellness solution, an online information management and patient communication software tool.

    Founded in 1992, PTS Diagnostics was specially recognized by Inc. Magazine as a Five-Time Inc. 5000 Honoree. The company earned its spot on the list with rankings in 2007, 2008, 2013, 2014 and now 2015.

    “As we continue to grow our business in the US and around the globe, we are pleased that our devices will test upwards of 25 million people this year,” said Huffstodt. “Our nearly 180 employees work hard to continue our ongoing commitment to provide a full suite of world-class point-of-care diagnostic solutions to healthcare professionals of all kinds, all around the world.”

    The Inc. 5000 profiles are available on http://www.inc.com.

    “The story of this year’s Inc. 5000 is the story of great leadership. In an incredibly competitive business landscape, it takes something extraordinary to take your company to the top,” said Inc. President and Editor-In-Chief Eric Schurenberg.

    Huffstodt concluded, “It’s gratifying for all of us to see our growth strategies validated in the marketplace and recognized by the media. Our goal is for a repeat performance in 2016.”

    About PTS Diagnostics
    PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.

    PTS Diagnostics’ signature products include the CardioChek® lipid analyzer and the A1CNow® family of products. The CardioChek® family of products have screened more than 120 million patients worldwide while the A1CNow® product line works to enable people to lead healthier lives through ongoing management of diabetes. Together these products help identify individuals with cardiometabolic syndrome, a cluster of conditions that increase risks of developing cardiovascular disease or diabetes.

    Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, distributes and markets products for distribution in more than 135 countries around the world. More information is available at www.ptsdiagnostics.com .

    For more information, visit www.ptsdiagnostics.com or contact Tom Wiser at 317-870-5610.

    SOURCE: PTS Diagnostics

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    PTS Diagnostics will Present at the American Diabetes Association's (ADA) 76th Scientific Sessions

    PTS Diagnostics will Present at the American Diabetes Association’s (ADA) 76th Scientific Sessions

    Manufacturer of A1CNow+® will exhibit and present a poster at the world’s largest meeting on diabetes June 10-14 in New Orleans

    Indianapolis – June 9, 2016 – PTS Diagnostics, the U.S.-based manufacturer of point-of-care blood testing devices, including the CardioChek® and A1CNow® systems, will exhibit and participate in the poster sessions at the American Diabetes Association’s (ADA) 76th Scientific Sessions held in New Orleans.

    PTS Diagnostics and eTrueNorth’s poster titled “Failure of Fasting Blood Glucose Screening to Detect All Persons with Diabetes or Prediabetes” will be on display in the “Clinical Therapeutics/New Technology–Glucose Monitoring and Sensing” area in the Poster Hall on June 11 to June 13. James Anderson, MD, lead author of the presentation and PTS Diagnostics’ medical director, will be available to discuss his research on Sunday, June 12, from noon to 2:00 p.m. at the poster’s location, 864-P.

    Further, Dr. Anderson will participate in a moderated poster discussion in the session titled “The Role of Glucose Testing and Variability” on Monday, June 13 from 1 to 2:00 p.m.

    Attendees to the ADA Scientific Sessions can visit PTS Diagnostics in Booth #117 during the show.

    “PTS Diagnostics is pleased to be contributing to the body of knowledge that strives to screen, diagnose, treat and manage diabetes,” said Dr. Anderson. “At PTS Diagnostics, our focus is to provide healthcare professionals an easy, fast and accurate way to measure A1C. Our presentation focuses on the importance of A1C screening and testing for at-risk individuals.”

    At the conclusion of the ADA event (June 14), this poster presentation will be available at www.a1cnow.com.

    PTS Diagnostics manufactures A1CNow+® system, a fast and easy way of obtaining accurate A1C results with just a fingerstick in just 5 minutes at the point of care. The portable, small medical device can easily be used in multiple exam rooms, is CLIAwaived, FDA-cleared and is NGSP certified. This innovative technology enables healthcare professional to communicate face-to-face with patients about their diabetes control in minutes, not days.

    About PTS Diagnostics
    PTS Diagnostics is an innovative global point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service. Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, distributes and markets products for distribution in more than 135 countries around the world. For more information, visit www.ptsdiagnostics.com or contact Tom Wiser at 317- 870-5610 or twiser@ptsdiagnostics.com.

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    PTS Diagnostics Announces New FDA 510(k) Clearance for Extended HDL Range Lipid Panel Test Strips

    PTS Diagnostics Announces New FDA 510(k) Clearance for Extended HDL Range Lipid Panel Test Strips

    Expanded range of HDL cholesterol measurement allows CardioChek® analyzers to serve a larger population

    Indianapolis, IN – DATE – PTS Diagnostics, the US-based manufacturer of point-of-care biometric testing devices, announced today that the US Food and Drug Administration (FDA) has cleared1 an expanded top range for measurement of HDL cholesterol (HDL) to 120 mg/dL (3.1 mmol/L) for the company’s PTS Panels® lipid panel test strips. The PTS Panels lipid panel test strip now has a measurement range of 20 to 120 mg/dL (0.52 to 3.1 mmol/L) for HDL. Additionally, the lipid panel shelf life has increased due to the use of new test strip vials.
    This change means the CardioChek® lipid analyzers can now serve about 98 percent of the adult population2, expanding the device’s ability to provide results for those individuals who tend to have higher HDL (good) cholesterol.

    “While very much desired in the United States, there is significant global customer demand for our CardioChek system to measure higher HDL cholesterol levels,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “Especially in countries like China, guidelines require an LDL measurement for all patients who get a lipid panel test, which can sometimes be difficult if HDL ranges are too high. For individuals with very healthy HDL cholesterol above 100 mg/dL, our customers have relied on retesting with venous blood to obtain LDL results. This expansion to our upper range for HDL will result in more LDL results being available and should eliminate a lot of retesting and the associated cost and inconvenience. This will create even greater efficiencies.”

    The change provides a further competitive edge over other point-of-care lipid analyzers on the market today.

    “Our nearest competition’s technologies cannot read HDL as high as the CardioChek system,” said Huffstodt. “While CardioChek analyzers can now provide measurements for an estimated 98 percent of the population, other competitive lipid analyzers can only provide results to an estimated 93 to 95 percent2,3. This means as many as one in 20 individuals may not be able to get a result from other lipid analyzers.”

    CardioChek analyzers and PTS Panels® test strips have a proven success record of providing lab-quality results in as little as 90 seconds, all from a fingerstick.

    Recognizing the strong connection between heart attack, stroke, and diabetes, CardioChek analyzers provide rapid on-site blood chemistry values and measurements to help identify at-risk individuals. As one of the fastest, most cost-efficient, and user-friendly analyzers on the market today, the CardioChek Plus system accurately tests lipid profile and glucose simultaneously with one fingerstick. In as little as 90 seconds, it provides on-site results using the same technology as clinical laboratories.

    PTS Panels lipid panel test strips measure total cholesterol, HDL cholesterol, and triglycerides, and allow calculation of LDL cholesterol and TC/HDL ratio. No refrigeration of reagents is needed, which now have a shelf life of 20 months from the date of manufacture. The CardioChek Plus system and PTS Panels test strips are stored at room temperature. This handheld, battery-operated analyzer is compact and lightweight, making it easy to transport and store. CardioChek systems are CLIA-waived and meet NCEP guidelines for accuracy and precision. The CardioChek Plus analyzer, which offers simultaneous testing of lipid profile and glucose, has wireless communication capabilities which simplify data transfer. In addition, the CardioChek Plus analyzer is CRMLN-certified for cholesterol and HDL cholesterol testing.

    About PTS Diagnostics
    PTS Diagnostics is an innovative, global, point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service. Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, distributes and markets products for distribution in more than 135 countries around the world. PTS Diagnostics, along with Trividia Health, have become members of Sinocare, a biosensor technology company that enables both medical professionals and individuals across the globe to identify, monitor and diagnose chronic diseases at the point of care. For more information, visit www.ptsdiagnostics.com or contact Kelly McClain at 317-870-5610 or kmcclain@ptsdiagnostics.com.

    1. The FDA clearance letter can be found at www.fda.gov and searching K151545.
    2. THE CANHEART Study, Vol. 68, No. 19, 2016, The Journal of The American College of Cardiology
    3. AlereTM Cholestech LDX Lipids CLSI Packet
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