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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 [email protected].

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
LIT 001810 Rev. 0 03/17
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PTS Diagnostics Opening New Global Headquarters, Poised to Continue Record Growth

PTS Diagnostics Opening New Global Headquarters, Poised to Continue Record Growth

Private groundbreaking ceremony was held on Tuesday, May 15 in Whitestown

INDIANAPOLIS (May 24, 2018) – PTS Diagnostics, a U.S.–based manufacturer of point-of-care biometric testing devices, today announced that they are expanding operations in Indianapolis and building a new global headquarters.

In order to support continued rapid growth, the in vitro diagnostics company is investing in additional manufacturing and office space, and moving their global headquarters to Whitestown. The new 135,000 square foot building is slated to open in June of 2019 on the southwest corner of Anson Blvd and C.R. 450 South.

A private groundbreaking ceremony with executives, architects, builders and representatives from PTS Diagnostics’ parent company, Sinocare, was held on the morning of Tuesday, May 15. A company-wide celebration is planned for summer 2018.

“PTS Diagnostics is still in high-growth mode, and our organization has evolved considerably in the past decade,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “As an organization, we pride ourselves on the ability to adhere to our core Hoosier values while scaling the business globally in accordance with growing demand and the expansion of our product lines. In addition to acquiring a manufacturing facility in California, we recently opened a sales office in Bangalore, India. In December, we announced the launch of a new retail point-of-care software for health screeners that is poised to create a niche in the expanding field of population health management.”

PTS Diagnostics currently has more than 150 employees in its flagship Indianapolis location and 86 employees in its Sunnyvale, California facility, which was acquired in late 2013. The company continues to grow much faster than the rate of industry growth, and this expansion will bring jobs to Indianapolis in the finance, marketing, chemistry, engineering, and manufacturing sectors, amongst others. Interested applicants are encouraged to monitor the PTS Diagnostics career center at ptsdiagnostics.com/career-center.html.

According to Indiana University’s Kelley School of Business, the economic impact of Indiana’s life sciences industry has climbed to more than $63 billion and is comprised of roughly 60,000 employees – making it one of the top states for in vitro diagnostics.

“The Browning/Duke Realty joint venture is proud to partner with PTS Diagnostics and assist them with the development of a building that is capable of meeting their growth and manufacturing needs, said Mark Hosfeld, Vice President of Leasing and Development at Duke Realty. “Indiana has a booming life sciences sector and this new global headquarters represents a continued commitment to the point-of-care technology that will further solidify their place in this rapidly growing industry.”

About PTS Diagnostics:
Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek® products to assess cardiovascular disease risks for more than 140 million patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. From our headquarters in the United States of America, we design, manufacture, and market our productsto more than 140 countries around the globe. For more information, visit ptsdiagnostics.com.

About Browning
Founded in 1977, Browning remains one of the premier development companies in Indianapolis and is engaged in the acquisition, development, construction, leasing, management, ownership and disposition of investment real estate properties, primarily in the Indianapolis metropolitan area. In total, Browning has developed and constructed more than 25 million square feet of space of bulk industrial space. To learn more, visit: www.browninginvestments.com.

About Duke Realty Corporation
Duke Realty Corporation owns and operates approximately 149 million rentable square feet of industrial assets in 20 key U.S. logistics markets. Duke Realty is publicly traded on the NYSE under the symbol DRE and is listed on the S&P 500. The company maintains a Baa1 rating from Moody’s Investor Service and a BBB+ rating from Standard & Poor’s Financial Services. More information about Duke Realty Corporation is available at www.dukerealty.com. Duke Realty also can be followed on Twitter, LinkedIn, Facebook and YouTube.

Press Contact:
Ryan Simpson, Marketing Associate
317-870-5610
[email protected]

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Kroger Health and PTS Diagnostics Announce CardioChek Plus Partnership

News Provided by Kroger Health 

Kroger Health and PTS Diagnostics Partner to Help Americans Better Prevent, Diagnose and Treat Diabetes and Heart Disease

CardioChek® Plus analyzer to be rolled out in more than 2,000 Kroger Health clinics and pharmacies across the country

INDIANAPOLIS (Jan. 29, 2019) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care testing devices and Kroger Health, The Kroger Co.’s nationwide arm of health and wellness facilities, services and programs, announced today the full rollout of CardioChek Plus analyzers for point-of-care blood testing to help identify individuals at-risk of heart attack, stroke, and diabetes.

CardioChek Plus analyzers provide accurate, on-site results in as little as 90 seconds using the same technology as clinical laboratories. Its speed and portability combined with the reach and influence of Kroger Health pharmacies and clinics will increase the number of potential patients who are able to receive preventative health screenings and begin clinical protocols.

“With nearly one-third of Americans suffering from diabetes, prediabetes, or high-cholesterol, the time for more innovative and turnkey solutions is now,” said Colleen Lindholz, President, Kroger Health. “One of the best ways to combat these issues is to ‘know your numbers’. And that’s why easy, economical and efficient testing methods are so important. When you know if you’re at-risk, you can take the actions necessary – whether that is with your diet, exercise or medication – to begin living a healthier life.” 

The CardioChek Plus system accurately tests lipid profile and glucose simultaneously with one fingerstick, eliminating the need for additional testing or machinery, and enabling a more seamless process for the customer. It is one of the fastest, most cost-efficient, and user-friendly analyzers in the world. The system measures total cholesterol, HDL cholesterol, triglycerides and glucose, and provides real-time readings and ratios that are immediately documented by trained associates onsite. Because of its handheld, portable design, the CardioCheck Plus analyzers are easy to transport, store and operate. 

Implementing the switch to The CardioChek Plus in all Kroger Health locations is another meaningful move towards eliminating preventable disease through early identification, targeting disease progression. Additionally, the speed and portability of The CardioChek Plus combined with the reach and influence of Kroger Health pharmacies and clinics increases the number of patients able to receive preventive screenings and begin clinical protocols.

“Our partnership with Kroger Health is an important step towards improving the overall state of population health,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “Nearly 90 percent of Americans live within five miles of a Kroger Health pharmacy or clinic and theseindividuals can now be quickly monitored for cardiometabolic conditions.”

Kroger Health includes more than 22,000 healthcare associates across over 2,100 pharmacies and clinics. Their trained professionals provide services, treatment and coaching in multiple areas, from nutrition counseling and weight loss programs, to diabetes prevention and immunization services. The CardioChek Plus rollout coincides with Kroger Health’s broader health and wellness initiatives, including the “Wellness Your Way” campaign, designed to provide personalized solutions for healthcare to the more than 60 million Americans who visit the Kroger family of companies – including Kroger, Ralph’s, Fry’s, and Fred Meyer – each year.

The CardioChek Plus is FDA – cleared, CLIA – waived and meets National Cholesterol Education Program (NCEP) guidelines for accuracy and precision. The final rollout of analyzers will be complete by February 2019.

About PTS Diagnostics:
Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek® products to assess cardiovascular disease risks for more than 140 million patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. From our headquarters in the United States of America, we design, manufacture, and market our products to more than 140 countries around the globe. For more information, visit ptsdiagnostics.com.

About Whitmire Medical:
Established in 1986, Whitmire Medical specializes in point of care diagnostic solutions for pharmacy and IDN applications. Utilizing a consultative approach, we partner with users to deliver best-in-class products and services tailored to their needs with a focus on optimizing clinical, operational and financial outcomes. Beyond exceptional pricing and traditional distribution functions, Whitmire offers personalized logistic and implementation support, training, and troubleshooting assistance by AACC educated POC specialists. For more information, visit www.whitmiremedical.com.

About The Kroger Co.
At The Kroger Co. (NYSE: KR), we are dedicated to our Purpose: to Feed the Human Spirit™. We are nearly half a million associates who serve over nine million customers daily through a seamless digital shopping experience and 2,800 retail food stores under a variety of banner names, serving America through food inspiration and uplift, and creating #ZeroHungerZeroWaste communities by 2025. To learn more about us, visit our newsroom and investor relations site.

Press Contacts:
The Kroger Co.
Customer Relations
513-762-4000, [email protected]

PTS Diagnostics
Ryan Simpson, Senior Marketing Associate
317-870-5610 – [email protected]

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Q&A: Point-of-Care Solutions and the Changing Healthcare Environment

At PTS Diagnostics, people are essential to our organizational success. We caught up with Bridget Melland, Director of Corporate Accounts, to learn more about the impact that our solutions make on those with chronic conditions.

Here’s what she had to say:

Q: Describe your role and the impact that you hope to leave on population health.

A: I work with large corporate and retail accounts that utilize our point-of-care product lines. Together we introduce these chronic disease management solutions to end users with the goal of improving lives.

In order to develop chronic disease management programs at the corporate level, I first must ensure that I fully understand each client’s goals, objectives, and barriers. Active listening enables me to align the resources and tools that will help them reach their goals.

Successful programs have the potential to reach and improve the lives of individuals who may have been unreachable under the standard physician-centric healthcare model.

Q: What trends in the healthcare industry have you noticed over the past several years and how is PTS Diagnostics suited to take advantage of these trends?

A: Healthcare consumers are looking for care that is convenient and meets them where they are, e.g. pharmacies, dental offices, grocery stores, etc. More and more, wearables and apps are driving healthcare consumer engagement. I anticipate that this trend of digital reliance will only increase as younger generations become more comfortable with emergent technology.

Another prominent change that has occurred is in regard to healthcare reimbursement laws. Healthcare systems are now being rewarded, or penalized, based upon their ability to keep patients healthy – a reversal from the standard fee-for-service model. 

PTS Diagnostics is addressing both of these trends head-on with our new PreVantageTM suite of solutions which are intended to assist with optimizing reimbursement. PreVantage enables me to be a single point of contact that can offer a full portfolio of solutions, helping my clients to “bring it all together.”

Q: What does success look like to you and how do you achieve it?

A: To me, success comes through enabling consumers to access actionable results and engaged healthcare professionals in nontraditional settings.

Healthcare consumer testimonials that highlight how point-of-care technology and chronic disease management tools can improve the lives of those impacted by diabetes and associated comorbidities are incredibly exciting.

The ultimate reward is knowing that my day-to-day role can positively impact others.

Q: Why do you believe that partnerships are essential to generating positive outcomes?

A: With partnerships, it’s essential to go above and beyond the traditional approach in order to ensure that both sides will support each other’s business growth and needs.

For example, we recently partnered with Whitmire Medical, one of our valued distributors, to help onboard a client’s numerous clinics to our CardioChek® Plus for point-of-care cholesterol testing.

Whitmire was able to provide personalized logistic and implementation support, training, and troubleshooting assistance by educated point-of-care specialists. This extra layer of support ensured a successful experience.

Q: What do you like most about working with our corporate accounts?

A: Their goals and objectives always require an extremely high level of strategy and collaboration that will stretch the limits of all team members. Can-do attitudes, risk taking, teamwork, and innovation are a just a few of the traits that describe the companies and individuals that I work alongside. Their energy and passion for improving health outcomes is contagious.

Q: What else would you like to emphasize in regard to the healthcare industry and the accounts that you manage?

A: PTS Diagnostics understands the complexities of developing and implementing a chronic disease management program. Our experience with point-of-care technology and chronic disease management enables us to take key learnings from multiple clients and build a plan that is achievable.

Overall, all manufacturers and distributors are not created equal, so developing customized implementation plans are a must. Moreover, partnerships and business development must be continuous; as the industry changes, we must strategically adapt in order to achieve success.

We thank Bridget for lending us her time in order to highlight the importance of working with our retail partners in order to shed light on the positive changes being made as a result of our point-of-care solutions.

Readers with questions about any aspect of this blog are encouraged to connect with PTS Diagnostics.

Bridget Melland | Director of Corporate Accounts