International Trade Commission Rules ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

International Trade Commission Rules ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

Final determination finds PTS Diagnostics’ patent numbers 7,087,397 and 7,625,721 were infringed upon

WHITESTOWN, Ind. (April 17, 2020) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care medical testing devices announced today that the U.S. International Trade Commission (ITC) issued a final determination finding that ACON Laboratories, Inc. and ACON Biotech (Hangzhou) Co.’s importation of (ACON) 3-1 Lipid Panels has violated Section 337 of the Tariff Act because their devices infringe PTS Diagnostic’s U.S. patent numbers 7,087,397 and 7,625,721.

The ITC, a federal agency responsible for investigating unfair trade practices, issued a limited exclusion order prohibiting ACON from importing their 3-1 Lipid Panels into the U.S. (International Trade Commission Investigation No. 337-TA-1116).

The ruling explained that ACON’s 3-1 Lipid Panels infringe claim 19 of the ‘397 patent and claims 1, 4, 6, 8, and 15 of the ‘721 patent. Further, the ITC found that the two patents are valid, rejecting all ACON’s arguments to the contrary. The ITC concluded that ACON’s importation into the U.S., sale for importation, or sale in the U.S of the ACON 3-1 Lipid Panel’s violated section 337 of the Tariff Act.

“We applaud the International Trade Commission’s determination; the ruling demonstrates that we are committed to protecting ourselves against anyone who infringes our broad patent portfolio,” said Jonathan Chapman, President and CEO of PTS Diagnostics. “Moreover, we are proud that the healthcare industry has widely embraced our CardioChek® lipid measurement system, which has screened millions of patients worldwide. I would personally like to thank the PTS Diagnostics’ employees who create our innovative products which positively impact so many patients and their diligence around protecting these inventions, as well as our legal counsel for their strong representation.”

Recognizing the link between cardiovascular disease and diabetes, CardioChek analyzers accurately test lipid profile and glucose simultaneously in as little as 90 seconds via fingerstick in order to help identify at-risk individuals. PTS Panels® lipid test strips measure total cholesterol, HDL cholesterol, and triglycerides, calculate LDL cholesterol and TC/HDL ratio, and do not require refrigeration. CardioChek® systems are CLIA- waived and meet NCEP guidelines for accuracy and precision.

The patents declared in the investigation cover the CardioChek family of products, including lipid analyzers and PTS Panels® test strips, which are manufactured in the U.S. PTS Diagnostics was represented in the proceeding by Haynes and Boone, LLP and intends to fully defend the final determination against any efforts for review or appeals.

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 millions of 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. For more information, visit ptsdiagnostics.com.

Press Contact

Ryan Simpson, Marketing Communications
317-870-5610 –  rsimpson@ptsdiagnostics.com

PTS Diagnostics and MedPro Healthcare Sales Solutions Enter Into Partnership

PTS Diagnostics and MedPro Healthcare Sales Solutions Enter Into Partnership

Effective immediately, augments existing accomplished sales force

WHITESTOWN, Ind. (April 1, 2020) – PTS Diagnostics, a U.S.-based manufacturer of point-of- care medical testing devices announced today that they are partnering with MedPro Healthcare Sales Solutions, a leading healthcare contract sales organization.

The partnership adds positions to the existing PTS Diagnostics sales force. These new representatives will be strategically staggered throughout the country and managed by PTS Diagnostics directors and senior sales managers. Together they’ll be responsible for expanding the footprint of the CardioChek® and A1CNow® product lines.

“MedPro’s support is crucial to achieving our core mission of closing gaps in care and potentially improving the outcomes of individuals with chronic conditions such as diabetes and cardiovascular disease,” said Cliffe Allen, VP of U.S. Sales of PTS Diagnostics. “Their knowledge regarding point-of-care testing combined with exceptional distribution relationships positions us for ongoing success in numerous vertical markets.”

MedPro was founded in 2006 and has grown into a leading sales force that’s trusted by manufacturers and distributors of all sizes. Their team’s connections span across a wide spectrum of healthcare delivery models, allowing for a streamlined sales cycle.

PTS Diagnostics’ solutions represent the first and only point-of-care lipid, glucose, and HbA1c tests sold by MedPro representatives.

“We’re thrilled to partner with PTS Diagnostics and believe that the certified accuracy, precision, and speed of their solutions will be a value add for physician offices, pharmacies, walk-in clinics, and more,” said Manny Losada, President of MedPro Healthcare Sales Solutions. Together we hope to positively impact at-risk populations at the point of care.

This announcement comes on the heels of PTS Diagnostics’ recent A1CNow+ Controls™ product launch and it precedes future 2020 product announcements.

To learn more about PTS Diagnostics or to connect with a sales representative, email: customerservice@ptsdiagnostics.com, or call 877-870-5610.

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 millions of 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. For more information, visit ptsdiagnostics.com.

About MedPro Healthcare Sales Solutions

Med-Pro Associates is a nationwide independent rep group specializing in representing leading manufacturers across the country who sell their products both through distribution and direct to the hospital, long term care, physician, dental and veterinary markets.

Press Contact

Ryan Simpson, Marketing Communications
317-870-5610 –  rsimpson@ptsdiagnostics.com

PTS Diagnostics Announces New Rapid-Detection COVID-19 Test

PTS Diagnostics Announces New Rapid-Detection COVID-19 Test

Developed by parent company, Sinocare Inc., available in the EU, U.K. and South Africa  

WHITESTOWN, Ind. (March 24, 2020) – PTS Diagnostics, a U.S. based manufacturer of point-of-care medical testing devices announced today the availability to select non-US markets a rapid, cost-effective COVID-19 antibody test, through their parent company.

The CE-marked SARS-CoV-2 Antibody Test developed by PTS Diagnostics’ parent company Sinocare Inc., is a rapid, accurate, easy to use point-of-care antibody test kit which can qualitatively detect IgM and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15-20 minutes.

The test kit comes with SARS-CoV-2 antibody test strips, a capillary tube, buffer solution and a package insert. To administer the test, a medical professional collects 10 µL of whole blood, serum, or plasma via venous draw collected in an EDTA or heparin tube. The collected  sample is then transferred with the provided capillary tube and applied to the test strip’s sampling area. They then add 2-3 drops of buffer solution to the same area and wait 15-20 minutes. The test is qualitative, meaning that results will either read as positive, negative, or invalid. Unlike other COVID-19 tests, results are available onsite within minutes and neither a laboratory nor an instrument is needed.

The SARS-CoV-2 Antibody Test Strip is currently available to our distributors and strategic partners in the U.K., EU and South Africa. It will be rolled out to Australia and Russia in the very near future and is being sold in both five (5) and 25 count test boxes.

“Stopping or slowing the spread of COVID-19 is a global effort that begins and ends with testing and the ability to receive fast and accurate results,” said Jonathan Chapman, CEO and President, of PTS Diagnostics. “We’re excited that this breakthrough at the point of care can help deliver accurate results in minutes as opposed to the hours or days required from most COVID-19 tests. This can potentially increase the number of patients tested per day and eliminate long and unnerving waiting periods for those being tested. A global pandemic requires a global response, and we’re proud to be working with our parent company towards the betterment of public health.”

The test strips are stable for 6 months when stored at 4-30°C and kept away from direct sunlight, moisture, and heat. A clinical evaluation performed by Sinocare revealed 96.3% sensitivity and 98.3% specificity in serum / plasma. In whole blood, the test had 95.0% sensitivity and 98.3% specificity.

For more information, please call customer service in the US at 317-870-5610 (direct) or 877-870-5610 (toll-free US only). Connect with your EU, U.K. or South Africa distribution partner if you are interested in purchasing the SARS-CoV-2 Antibody Test. Find them via PTS Diagnostics Distributors.

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 millions of 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. For more information, visit ptsdiagnostics.com.

Press Contact

Ryan Simpson, Marketing Communications
317-870-5610 –  rsimpson@ptsdiagnostics.com

PTS Diagnostics Announces Jonathan Chapman as President and Chief Executive Officer

PTS Diagnostics Announces Jonathan Chapman as President and Chief Executive Officer

Effective immediately, adds proven record of global leadership and demonstrated success

WHITESTOWN, Ind. (March 24, 2020) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care medical testing devices announced today that Jonathan Chapman has been appointed as President and Chief Executive Officer.

Mr. Chapman brings 20 years of leadership experience in the medical device industry, most recently serving as President of ARKRAY USA, Inc. He joins PTS Diagnostics with an accomplished track record regarding mergers and acquisitions, post-acquisition integration, global product launches, market identification, and strategic positioning.

I’m honored to join the PTS Diagnostics team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes and assessment of cardiovascular disease risk,” said Jonathan Chapman, President and CEO of PTS Diagnostics. “We will continue our legacy of bringing leading innovation to patients across the globe. PTS Diagnostics’ broad capabilities, world-class leadership team, and committed people give me great confidence about our future.”

Mr. Chapman received a Bachelor of Arts from Sheffield University UK, LLM Commercial and Corporate Law from University of London (SOAS) and LLM Health Law from Hamline Law School, St. Paul, MN. PTS Diagnostics is confident that his international experience will be immensely valuable when leading the organization across global markets.

Mr. Chapman will be based out of the Whitestown, Ind. global headquarters.

As a comprehensive point-of-care diagnostics company, PTS Diagnostics manufactures solutions that close gaps in care for patients with chronic conditions such as diabetes, cardiovascular disease, and other related comorbidities.

For more information about PTS Diagnostics and the executive leadership team, please visit ptsdiagnostics.com,
call 877-870-5610, or reference the press contact information below.

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 millions of 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. For more information, visit ptsdiagnostics.com.

Press Contact

Ryan Simpson, Marketing Communications
317-870-5610 –  rsimpson@ptsdiagnostics.com

PTS Diagnostics Announces A1CNow+ Controls™

PTS Diagnostics Announces A1CNow+ Controls™ 

Refrigerated storage up to 8 months, initially available in U.S., Europe

WHITESTOWN, Ind. (March 23, 2020) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care medical testing devices announced today that they are launching A1CNow+ Controls for the A1CNow®+ Test System.

Initially available in the United States, European Union, and the United Kingdom, A1CNow+ Controls can be stored frozen for up to three years, refrigerated for eight months, or at room temperature for seven days. Intended to ensure accurate A1C results, the solution comes with two levels, each in a dropper style vial and can be successfully run in minutes.

“PTS Diagnostics-branded controls ensure that our customers have access to a high-quality solution that meets our stringent regulatory guidelines,” said Mark Duncan, Director, Global Product Management. “We are excited to provide benefits such as easy-to-use dropper style vials and extended shelf life.”

For additional information about the product, reference the A1CNow+ Controls webpage. Please call customer service at 317-870-5610 (direct) or 877-870-5610 (toll-free US only) with any questions. Connect with your local distribution partner if you are interested in purchasing A1CNow+ Controls or any other product. Find them via PTS Diagnostics Distributors.

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 millions of 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. For more information, visit ptsdiagnostics.com.

Press Contact

Ryan Simpson, Distribution Marketing
317-870-5610 –  rsimpson@ptsdiagnostics.com