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European Commission Launches New Plan to Address Antimicrobial Resistance

The British In Vitro Diagnostics Association (BIVDA) recently highlighted attention in Europe on the subject of antimicrobial resistance (AMR). [NOTE: the BIVDA Weekly Update is behind a members-only firewall.]

In their newsletter, BIVDA shared a link to an article from the Financial Times [also behind a paywall] which coincided with the G20 meeting. The FT article noted that AMR was expected to come up as an issue during discussions on health.

AMR is not a new issue for Sekisui Diagnostics. We’ve discussed AMR and the role Sekisui and its distributors have played in supporting initiatives to reduce antibiotic consumption.

Antimicrobial Resistance: A Global Challenge
The European Commission‘s (E.C.) recent publication – “A European One Health Action Plan Against Antimicrobial Resistance (AMR)” – calls for encouraging the use of “diagnostics in medical and veterinary practice.” Their press release states:

“Today the Commission adopted a new Action Plan to tackle Antimicrobial Resistance (AMR) – a growing threat that is responsible for 25,000 deaths and a loss of €1.5 billion in the EU every year.”

How critical an issue is AMR?
|Worldwide, nearly 700,000 people die annually due to an antibiotic resistant infection. AMR is responsible for an estimated 25,000 deaths in the EU alone. Europe – like many other global regions – is taking it very seriously.

According to Vytenis Andriukaitis, Commissioner for Health and Food Safety, by 2050 AMR could lead cancer as a cause of death if government fails to take action.

The increasing prevalence of AMR can be attributed to a number of factors, from the overuse of antibiotics in livestock to the over prescription and misuse of antibiotics in humans.

From the E.C.’s Q&A: “Lack of awareness also remains a key factor: 57% of Europeans are unaware that antibiotics are ineffective against viruses, 44% are unaware that they’re ineffective against cold and flu.”

The new Action Plan focuses on everyone in the medical or healthcare communities involved in the use of antimicrobials – including nurses & doctors, pharmacies, hospital administration and others. The guidelines are intended to work in conjunction with existing national infection prevention & infection control guidelines in European member countries.

One key aspect of the Action Plan involves surveillance efforts – including use of diagnostics – to improve public health while reducing the misuse of antibiotics. This also includes the research into – and development of – novel diagnostics:

“Novel, rapid and reliable diagnostics are crucial for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner. By tailoring the treatment to the nature of the infectious pathogen and its resistance pattern, diagnostics help reduce the unnecessary use of antimicrobials in humans and animals. Such novel diagnostics are in the process of entering the market but more tests are needed to guide a more efficient use of existing antimicrobials in the human and animal health sectors. Novel diagnostics will also make it possible to recruit the right patients in clinical trials for new treatments, making the trials more efficient.” [European One Health Action Plan against Antimicrobial Resistance – page 15]

Want to learn more? You can read the EC Action Plan here (pdf file), or learn more about antimicrobial resistance at the European Commission Health and Food Safety website.

Clinical Chemistry: Why Pour Over?

In the field of clinical chemistry, most  manufacture instruments are intended for use with the manufacturer’s specific packaged and barcoded reagents. This is often referred to as a ‘closed’ system.

What some labs are not aware of is that their chemistry analyzer may not be a fully ‘closed’ system.

Why does it matter if your system is closed or open?

If your system is not a closed analyzer, it opens up the option for your lab to use ‘pour over’ reagents. This means you have the option to utilize open channels on the instrument to expand the menu for tests that the manufacturer doesn’t offer.

Pour Over: Commonly Known as Open-Channel,  User-Defined Tests (UDT), or Third-Party,
The process of ‘pouring over’ reagents refers to filling the empty manufacturers’ cartridge (which vary in shape and size, depending on the specific instrument) with a reagent sold in generic packaging.

Advantages of an Open Channel Assay
Although most instrument manufacturers provide extensive test menus for their analyzers, there is an occasional assay that is missing from the test menu. This is where an open-channel assay can help fill in gaps. What may currently be an expensive test for a laboratory to send out to a reference lab, can now be added to the laboratory’s instrumentation bringing in revenue and increasing patient care by decreasing turn-around times.

Another advantage of using an open channel assay is minimizing the amount of waste. Laboratories are able to adapt user-defined assays to fit their testing volume in order to maximize the amount of tests that can be utilized in a reagent kit. Pour over assays give a laboratory the flexibility to place enough reagent on-board the analyzer to last the duration of the reagents on-board stability.

Choosing open channel assays for reagent needs can benefit labs greatly – especially when it comes to convenience. This method gives your lab control over how much reagent is used over a span of time, based on the number of requests for the specific test.

Open Channel Assays Can Increase Productivity & Capabilities
Labs are under pressure to produce more test results with fewer resources, forcing them to identify ways to reduce their total cost of ownership. Operating analyzers that use minimal reagents & consumables can increase the number of tests available in a reagent kit – thus boosting efficiency and saving money.

For many labs, the use of open channel testing is another way to reduce costs – with the added benefit of enabling the lab to perform novel assays – which are often otherwise not available.

If you want to learn more about pour-overs, give us a call at 1-800-999-6578.

What Happened at AACC in San Diego?

This year’s 69th AACC Annual Scientific Meeting & Clinical Lab Expo brought the laboratory medicine industry to San Diego – with a record-breaking 21,300 laboratory scientists and related careers in attendance from July 30 through August 3. Sekisui Diagnostics exhibited at the show, among the more than 2,300 booths.

The range of content covered in the AACC sessions was broad, and some of the topics were relevant to either our clinical lab customers or to Sekisui itself.

One particular topic of interest:

  • One of the plenary sessions – Antibiotic Resistance: A Public Health Crisis – spoke to a globally critical issue we have covered – and will continue to cover here: antimicrobial resistance (AMR). The session noted the evolving diagnostic tools and strategies that can be implemented to help aid in the prevention & control of antimicrobial resistance in medical facilities. AMR has become a serious issue, and is starting to take on the feel of a crisis.Consider:
  • According to the CDC, every year more than 2 million Americans become infected with antibiotic resistant bacteria – resulting in at least 23,000 deaths.
  • Europe isn’t faring any better. the UK government estimates that more than 25,000 deaths occur in the E.U. every year due to drug resistant infections.

As the clinical laboratory industry, we all play a role in helping to solve the problem. Whether it’s the development and deployment of new in vitro diagnostics, or medical practitioners & hospitals implementing better prescribing procedures, governments are starting to pay attention and act. We witnessed this recently with the European Commission’s Health Action Plan Against Antimicrobial Resistance (AMR) report.

Among our extensive diagnostic product lines, the Fastpack® and OSOM® stations were especially busy. There was very strong interest in point-of-care diagnostics this year – a growing trend. We especially noted an uptick in distributors (especially in Asia) wanting to sell Sekisui Diagnostics’ FastPack® IP system. 

On the Whiteboard: How Are You Mastering the Art of Diagnostics?
This year we brought back something we’d done at a previous AACC show but with a new approach which ties into our corporate campaign- an interactive whiteboard where we asked laboratory professionals to share their thoughts on how they are “mastering the art of diagnostics.”

It was a great way to hear from people across the industry. Some writings were filled with best wishes, others with invaluable customer input and feedback. And while some of it may find its way into our promotional programs throughout the year, other whiteboard thoughts will help us understand the needs of our clinical chemistry customers better.

Thanks to everyone who attended this year – and an especially big thanks to the staff (and their weary feet!) managing the Sekisui Diagnostics booth.

We look forward to seeing everyone next year at the 2018 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago – July 29 through August 2, 2018!

Helping Save Patient’s Lives: Diagnosing Sepsis

Sepsis was identified as the most expensive in-patient cost in U.S. hospitals in 2014, costing nearly $24 billion annually. Each year, over 26 million people develop sepsis, and it is responsible for the deaths of more than 5 million children. According to the Sepsis Alliance, severe sepsis takes the lives of 40% of those who contract it.

The Health Impacts of Sepsis
The Sepsis Alliance reports that – of those patients who survive – up to 50% are subsequently faced with post-sepsis syndrome. Sepsis survivors have a shorter life expectancy, can have a lower quality of life, and are 42% more likely to take their own life. Early detection of sepsis is key for ensuring survival and minimizing disability as much as possible.

Caused by any type of infection – from something as simple as a urinary tract infection to the flu or pneumonia – sepsis is fatal for one-third of patients who develop it. Furthermore, sepsis survivors are left irrevocably changed—facing chronic pain and fatigue, post-traumatic stress disorder, organ dysfunction and amputations.

How is Sepsis Detected?
Sepsis diagnosis is made by the patient’s doctor after a thorough review of the patient’s symptoms, history, and other relevant tests. Sepsis can be confirmed via a test that measures the levels of a protein in the blood known as procalcitonin.

PCT Biomarker for Early Diagnosis of Sepsis
A meta-analysis which included 30 studies and 3,244 patients found procalcitonin (PCT) to be a reliable biomarker for early diagnosis of sepsis. PCT values between ≥0.5 and 2.0 ng/mL suggest moderate risk, 2.0–10 ng/mL indicate high risk and values ≥10 ng/mL point to a high probability of developing severe sepsis and septic shock.

According to Diazyme Laboratories’ 510(k) Clearance announcement on April 25,2017:

“Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory tests in the diagnosis of sepsis. PCT is ubiquitously and uniformly expressed in multiple tissues throughout the body. In healthy conditions, PCT levels in circulation are very low. Rising PCT concentrations can be detected within 2 – 6 hours after infectious challenges and peak within 6 – 24 hours. Once an infection is under control, PCT levels decrease. This rapid response is highly specific to bacterial infections and has made PCT one of the most pertinent biomarker’s used in detecting bacterial infection or sepsis.”

The frequency of in-patient cases of sepsis, its high mortality rate and its potentially lasting effects demonstrate the need for better diagnostic tools in order for intervention and treatment to begin as early as possible. An easy-to-administer lab analyzer-compatible assay that can deliver results into the hands of clinicians quickly could have a significant positive clinical impact on halting the progression of sepsis in patients. This PCT assay may be the answer for your lab with a quick turn-around time, low sample volume and wide range of instrument parameters available.

What is the PCT?
The PCT is a latex-enhanced immunoturbidimetric assay. It was designed to be used on a wide variety of lab analyzers capable of reading absorbance at 600 nm. With this method, the PCT in the patient sample binds to specific anti-PCT antibodies on latex particles, causing them to agglutinate.

The relative turbidity created by the agglutination is then optically measured at 600 nm, and is proportional to the PCT concentration in the test sample. To calculate the PCT value, the optical signal is interpolated against a 6-point calibration curve. A suitable sample size is 20 µL, with initial test results available in just 10 minutes.

Is the PCT Assay Effective?
An analysis – Analytical evaluation of the procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800 – involved assessing limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, carryover, and method comparison between Diazyme PCT and BRAHMS Kryptor PCT using 129 serum inpatient samples.

Linearity was very good in the range and highly significant agreement was seen between this PCT assay and BRAHMS in a range of concentrations.

As the first homogenous PCT assay meant to be used on clinical chemistry analyzers, it saves both time and money, and can help you save lives.

Want to learn more? We’d be happy to help! Feel free to contact us here.

 

 

 

 

FDA Reclassifies Rapid Antigen Influenza Testing

On February 13, 2017, the FDA’s reclassification of rapid antigen influenza testing became effective. The reclassification impacts manufacturers of certain diagnostic devices used to test for influenza (flu).

Currently, there are a number of diagnostic tests that can help in the diagnosis of flu. They break down into two broad categories: Point-of-Care-based and Laboratory-based.

In the Point-of-Care Testing (POCT) space, two common techniques are:

  • Rapid Immunochromatographic Detection Tests (RIDTs), including both digital reader systems & traditional, manual read assays.
  • Rapid Molecular Tests

In larger laboratories and reference labs, you may find:

  • Immunofluorescence Direct or Indirect Antibody Staining
  • RT-PCR (nucleic acid methods are the new gold standard, replacing the cell culture)
  • Rapid Cell Culture
  • Viral Tissue Cell Culture

RIDT Tests in the Point-of-Care Setting
Rapid Influenza Diagnostic Tests (RIDTs) are immunoassays that can identify the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens, with results displayed qualitatively. There are a number of commercially-available RIDTs in use in the U.S.

RIDT tests are frequently used in point-of-care settings due to their cost-effectiveness, ease-of-use, and rapid results (often available in 15 minutes or less). These tests give doctors the ability to begin antiviral therapy (while reducing antibiotic use) during a single patient visit – ultimately leading to a decrease in hospitalizations and fewer unnecessary tests.

FDA Tightens Standards, Reclassifies RIDTs
However, there have historically been some challenges with RIDTs and their variability in performance. While they tend to show good specificity, they can deliver less-than-optimal sensitivity in respiratory specimens compared to RT-PCR or viral culture.

In some cases (for example, the H1N1 flu strain in 2009) RIDTs may be unable to detect the virus at all. For this reason, negative RIDT test results should be interpreted with caution given the potential for false negative results – especially during peak flu season in a community.

Based on these concerns, the FDA began work to reclassify antigen-based RIDTs as Class II devices in order to improve the overall quality of testing for influenza. The FDA has provided certain performance criteria that manufacturers will have to meet in order to market their influenza assays.

The new standards went into effect in February 2017. According to the FDA:

“The new minimum performance requirements for these tests detecting influenza virus antigens are expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus.”

What Does the FDA Reclassification Mean for RIDT Manufacturers?

For manufacturers who currently have a marketed device that does not meet the minimum performance criteria, a new 510(k) must be submitted demonstrating compliance with the special controls included in the new clinical performance standards before marketing the device.

There are several key takeaways from the FDA’s move:

  1. Rapid Antigen Influenza tests have been reclassified from Class I to Class II medical devices.
  2. Minimum performance requirements are mandated as compared to viral culture or molecular methods.
VIRAL CULTURE MOLECULAR
VIRUS Sensitivity Specificity Sensitivity Specificity
INFLUENZA A 90% (80% CI*) 95% (90% CI) 80% (70% CI) 95% (90% CI)
INFLUENZA B 80% (70% CI) 95% (90% CI) 80% (70% CI) 95% (90% CI)

*CI-Lower Confidence Interval

  1. Annual and Emergency Analytical special controls testing (test panel) will be undertaken by manufacturers to ensure continued performance monitoring. The FDA will collaborate with the Centers for Disease Control and Prevention (CDC) to ensure that an influenza virus analytical reactivity test panel is available to all test manufacturers.
  2. By January 12, 2018, manufacturers are required to be in compliance with the requirements imposed by the FDA to meet the Class II standards for rapid influenza diagnostic testing.

What Does the FDA Reclass Mean for Physicians and Labs?
Facilities testing for flu can continue to purchase their current product up until January 12, 2018 and utilize them until the kit’s expiration date. This provides facilities enough time to assess the performance data against the FDA criteria and engage clinicians and management on the next course of action for flu testing.

OSOM® Ultra Flu A&B Meets New FDA Criteria
We know you’re concerned about diagnosing patients correctly – especially during flu season, when so many symptoms can mimic other diseases.

Sekisui Diagnostics is committed to ensure that our products comply with the requirements imposed by the FDA to meet the Class II standards for rapid influenza diagnostic testing.

The OSOM® Ultra Flu A&B (Catalog #1006, view package insert) meets the performance criteria defined in the final rule (21 CFR 866.3328).

Questions about a Sekisui Diagnostics’ Rapid Influenza Diagnostic Test? Give us a call!

Notes from EuroMedLab Athens 2017

Sekisui Diagnostics recently exhibited at the 22nd IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine – perhaps best (and more easily) known as “EuroMedLab 2017.” It’s a large show – attended by about 5,000 biochemists, biologists, doctors, clinical chemists and pharmacists from all over the world.

Ancient History…and Cutting Edge Clinical Innovation
The congress was held at Athens’ Megaron Convention Centre. Within walking distance of the IFCC EuroMedLab 2017 congress venue were an incredible array of places of interest, all within a relatively small area surrounding the city center (Syntagma Square).

The multi-level exhibition area – which at first seemed confusing – actually led to people exploring the halls and discovering new companies. This resulted in a steady stream of visitors to the booth throughout the show.

What Was Hot at IFCC EuroMedLab?
There was a great deal of interest focused on our SEKURE® TPLA/RPR assays, used as an aid in the diagnosis of syphilis, which has been on the increase again since 2000.

Much of the interest in our TPLA/RPR assays can be attributed to the changing nature of lab & clinical testing in general. TPLA and RPR have begun shifting from the microbiology laboratory to the clinical chemistry laboratory.

Our Hb1Ac assay was also the focus of attendee interest (more on that below).

More generally, show attendees were introduced to the latest innovations from the fields of clinical chemistry, molecular diagnostics, cell counting and immunochemistry.

Innovations in Lab Medicine
The EuroMedLab 2017 scientific program offered a wide range of presentations, symposia, discussions, open sessions and workshops – all geared towards sharing recent state of the art innovations in 21st century Laboratory Medicine.

The Future of Point-of-Care Testing
Among the highlights of the congress, were some engaging sessions on Point of Care Testing (POCT). A number of point-of-care topics – assessing reliability, functionality, connectivity, clinical significance, and early clinical decision-making – were analyzed & discussed.

Other sessions reviewed existing and emerging technologies in the POCT field, and assessed the shifting of laboratory tests from central laboratory facilities to the clinic, family practitioners, and – in some cases – the patient’s home.

EuroMedLab Satellite Meeting: A Focus on Diabetes
We were also a sponsor and exhibitor at a related, two-day satellite meeting held June 15-16, immediately after EuroMedLab.

The meeting – held in Sounio, southeast of Athens – addressed diabetes innovations in both the laboratory and the clinic.

About 120 international delegates and key opinion leaders with a specific interest in diabetes participated in the meeting. Sessions provided a review of the state of the art in glucose monitoring, HbA1c, and future developments in diabetes and test methods.

The meeting presented an excellent opportunity to not only meet experts in the field of diabetes and HbA1c, but also to keep updated with the latest clinical & scientific thinking, and gain insight about other current market developments.

Sekisui participated in the HbA1c component of the meeting, which complemented the imminent launch in Europe of Sekisui Diagnostics’ new SEKURE® HbA1c enzymatic clinical chemistry assay. We were able to discuss this new assay with delegates at our table-top display.

There has been much deliberation on the topic of HbA1c. The session on the subject at the satellite meeting proved no exception: lively debate and discussion occurred with a number of topics, including:

  • HbA1c’s role in diagnosis.
  • controversies in interpretation.
  • HbA1c in the POCT setting.

Vitamin D Point-of-Care Testing: Faster, Simpler & More Cost-Effective

Vitamin D Point-of-Care Testing: Faster, Simpler & More Cost-EffectiveWhile Vitamin D is typically recognized for boosting tooth and bone health and warding off osteoporosis, studies are now finding that it can also protect us from malignancy, cardiovascular disease, diabetes, and bone disorders. Genome-wide analysis has also shown that Vitamin D plays a role in the expression of more than 200 human genes.

Uncovering Vitamin D Deficiency
Vitamin D deficiency has been found to be more widespread than previously thought. This deficiency has sparked creation of new guidelines for defining Vitamin D insufficiency and deficiency, along with recommended daily intake.

While this awareness has made testing more prevalent, its standardization is the result of advances in technology, immunoassay methods and automation. Today’s rapid, quantitative analytical techniques are faster, more cost-effective and more adaptable to a Point-of-Care setting—a win for both physicians and patients.

Recent studies have shown that a substantial percentage of the U.S. population has blood levels of 25-OH Vitamin D that approach the cut-off for Vitamin D insufficiency. This risk is multiplied when you use certain therapeutic drugs, including long-term steroids, antiepileptic drugs, L-thyroxine, gonadotropin-releasing hormone agonists, chronic lithium therapy, thiazolidinediones for diabetes, as well as antifungals, AIDS medications, and antacids.

Recommended Vitamin D Intake and Blood Levels
Daily Vitamin D3 intake recommended by the Institute of Medicine of the National Academies:

  • 600 IU/day for everyone up to age 70
  • 800 IU/day for everyone 71 years and older

These amounts correspond to a serum 25-OH Vitamin D level of at least 20 ng/mL.3. In addition, the Endocrine Society Task Force defines sufficient 25-OH Vitamin D as 25-50 ng/mL.

Advantages of Today’s Advances in Testing
In the past, Vitamin D has been quantified through competitive binding, using either high performance liquid chromatography (HPLC) or radioimmunoassay (RIA). For large reference laboratories, LC-MS/MS has become the gold standard. The high cost of the equipment and the staff training required make it unsuitable for point-of-care testing.

Wide availability of HPLC test kits has made HPLC-based Vitamin D analysis much more streamlined and affordable.

Advantages of immunoassay-based testing include:

  • Results which correlate more closely with LC-MS/MS than the results of HPLC-based assays
  • Easy-to-use, cost-effective kits are available that quickly and accurately measure 25-OH Vitamin D in plasma or serum.
  • Reimbursements are available for each test conducted in-house by physician practices in the U.S., providing a faster return on the practice’s investment.
  • Immediate results of monitored 25-OH Vitamin D levels make for better patient care and significantly enhance efficiencies for the physician’s practice

The precision and accuracy of today’s automated immunoassays have been shown to equal that of a centralized lab. Requiring no specialized expertise, they offer rapid results in 15 minutes or less – rather than hours later if the sample was sent out for testing. With the push of a button on the FastPack® IP System, for example, complex immunoassay results can be obtained in 12 minutes.

Thanks to on-demand testing, physicians only need one face-to-face visit to test for deficiency and treat it, or monitor Vitamin D levels and adjust supplementation as needed – saving time for both the patient and the physician. This point-of-care testing allows the patient to receive proper supplementation more promptly, guards against the consequences of deficiency, and leads to greater patient satisfaction.

 

 

 

Sekisui Diagnostics Exhibits at American Urological Association Annual Meeting

The 2017 Annual Meeting of the American Urological Association, held at the Boston Convention and Exhibition Center in May, saw excellent turnout. Some of the educational sessions were highly relevant to Sekisui Diagnostics.

This was the 112th annual meeting of the AUA – a leading industry organization for urologists and global urologic health care professionals and the “largest gathering of urologists in the world.” It is an excellent venue for learning the current developments in research, as well getting a first-hand look at some of the latest technology used in urologic medicine.

This year’s event was truly global in nature, with a large international presence representing (among other places) Liberia, the UK, New Zealand, Uruguay, Egypt, South Africa, Spain and elsewhere. Without fail, Point-of-Care testing was top-of-mind – especially among doctors and medical practitioners.

Hot Topics at AUA
In addition to cost, EMR interfacing was one of the most common questions our team fielded at the show. In fact, we’ve been fielding this question more and more frequently in the past few years as Electronic Medical Records have become standard industry practice. (Sekisui Diagnostics Fastpack IP system has the ability to download test data and interface with practice EMRs through a data port).

Of particular interest to attendees was Sekisui’s PSA test (read our earlier post on the Prostate-Specific Antigen, or PSA, Test). As mentioned above, there were a number of sessions relevant to the topic of prostate cancer.

Among them was Dr. Isaac Yi Kim (Research does not support changes to active surveillance criteria based on race, lecturer says), who referenced the disparities between African American men and Caucasians in the incidence of prostate cancer. At Monday’s Plenary session, Dr. Kim – Acting Chief of the Division of Urology at the Rutgers Robert Wood Johnson Medical School and Chief of the Section of Urologic Oncology at Rutgers Cancer Institute of New Jersey – stated “there are not enough data at this time to support modifying active surveillance criteria based on race.”

In another roundtable session moderated by Dr. Ian Thompson, Jr., experts discussed some of the challenges presented by prostate cancer, including “prostate specific antigen (PSA) recurrence in patients who have undergone radical prostatectomy.”

A number of other sessions – including poster sessions – also focused on the topic of prostate cancer – from screening & detection through to treatment & follow-up.

Other products of interest at the AUA show included our bacterial vaginosis (BV) tests, as well as other rapid tests & diagnostics from our extensive women’s health product line.

All in all, it was wonderful to catch up with our customers. Especially nice: receiving the feedback that some Sekisui Diagnostics products & systems with nearly a decade-and-a-half of hard clinical use are still going strong and delivering value for our customers!

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