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Published: June 13, 2012
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2012 MDEA Finalists in the IVD Category

This year’s finalists in the Medical Design Excellence Awards competition in the IVD category share what made their products stand out.

By: Beth W. Orenstein

Every year, UBM Canon, publisher of IVD Technology magazine, scours the globe for the most promising and innovative products in the IVD field deserving of its Medical Design Excellence Awards. A panel of judges, all of whom are experts in IVDs, evaluated the design and engineering, manufacturing effectiveness, and innovation of the products submitted, and chose the best for honors. The judges looked for those innovative products that are not only the most user friendly and cost effective but also promise to deliver accurate results quickly and improve healthcare for all. The winner of the awards will be announced May 23 during the MD&M East show in Philadelphia. Here’s a look at this year’s finalists and what makes them stand out.
Myla Microbiology Middleware System
Thanks to consolidations and ever-tightening healthcare budgets as well as an increasing demand for IVD tests, laboratory managers are under a great deal of stress these days. They must not only deliver accurate, high-quality results rapidly but

Myla Microbiology Middleware System by bioMerieux
Myla Microbiology Middleware System by bioMerieux

also often do so with smaller and less skilled workforces. These realities require labs to be as efficient and accountable as possible from the time the test culture arrives at their door until the results are made available via their information systems, whether a laboratory information system, a hospital information system, or both.
Enter bioMérieux (Marcy l’Etoile, France) and its informatics solution for microbiology laboratories: the Myla Microbiology Middleware System. Myla brings three key benefits to the microbiology laboratory, said Luis Pintado, IT solutions leader for bioMérieux North America. “One, it simplifies the network architecture and connectivity issues in the lab, thus saving space. Two, it improves the overall operational efficiency of the microbiology lab. And three, it makes the most relevant information readily available to clinicians so they can take action quickly.”
Myla is a software solution, so it is not physically capable of moving the specimens from one instrument to the next for testing. Not yet anyway. But Pintado said that day may not be all that far away. “It will get to the point where we will see a fully automated lab that does everything with little human intervention,” he said. Meanwhile, the Myla software solution allows technicians to avoid repetitive activities such as reentering patient and sample data for each step in the process. “Automation and instrument integration typically doesn’t exist in today’s microbiology lab,” Pintado said. “That’s where we as a company come in and what our new software solution is doing for microbiology lab instruments. It automates the process of moving results through the lab thus improving the overall workflow.” The automation means less need for human intervention and therefore fewer opportunities for errors, he said.
Admittedly, very small laboratories do not need a solution like Myla because they do not have the level of repetitive large-scale business that could fully benefit from it. But, Pintado said, Myla is the perfect solution for middle to large reference laboratories because “that’s where the volume and the real need for efficiency are.”
In designing the software solution during the past few years, bioMérieux understood that laboratories often have limited space. Consequently, Myla is a browser-based application, and users only need a single monitor or keyboard to run it from anywhere they have access to their local area network connections (be it on a laptop or an iPad). The server itself will fit on a standard-size tabletop or data center.
The new software solution not only frees physical space but also “space in the heads of the laboratory manager, enabling them to think about higher level issues,” Pintado said. It gives lab managers time to concentrate on how to enhance services for physicians and what’s happening at the lab or in the industry, Pintado said. Myla also has an intuitive dashboard design that allows technologists and managers to focus on the specific tasks needing attention immediately, such as driving down turnaround times to positively impact patient care.
Customers who have been using the earliest version say Myla has enabled them to improve their workflow and processes. “Where they used to run fewer tests a day due to queuing in front of a PC or an instrument to review a result, now they can run many more, and that means more revenue for them since the lab becomes more efficient in its workflow,” Pintado said. Because, thanks to Myla, doctors and patients are able to learn the results of their tests sooner, patients may be able to be treated and released from the hospital sooner. Providing appropriate treatments sooner and shortening hospital stays can result in overall savings to the healthcare system, Pintado said.
The system requires some training, but it is very basic, Pintado noted. The user interface is easy to use and interpret.
BioMérieux is slated to introduce upgrades and new versions of its Myla software frequently. “With every version, we’re enhancing connectivity, improving workflow monitoring, and reporting functionality,” Pintado said.
BioMérieux designed the software for microbiology based on input from microbiologists. “The microbiologists kept saying, ‘If I were able to do this, running my lab would be so much easier,’ and now they can,” Pintado said.
While Myla adds value to the lab and the healthcare system, its most important contribution is to the patient, Pintado said. By automating the microbiology lab and allowing its instruments to talk with one another, results are reported more quickly and with more accuracy, meaning a higher quality of patient care. “And that’s what it’s all about,” Pintado said. “We care about the patient, and when you do, everyone wins.”
Simplexa Direct and Simplexa Universal Direct Assay Kits
Focus Diagnostics’ (Cypress, CA) finalist products, the Simplexa Direct and Simplexa Universal Direct Assays, make it easier and faster for laboratories to perform molecular tests. The products should enable a wider range of healthcare professionals to access quality molecular testing.
The idea for the Simplexa Direct and Simplexa Universal Direct was born during the 2009 H1N1 pandemic. “We were testing

Simplexa Direct by Focus Diagnostics
Simplexa Direct by Focus Diagnostics

thousands of specimens per day in our lab, and we just could not keep up because conventional molecular testing requires technicians to have specialized training and a purification process that’s rather time consuming,” said Maurice Exner, PhD, vice president of research and development for Focus Diagnostics, a wholly owned business of Quest Diagnostics (Madison, NJ).
During the pandemic, molecular testing, such as real-time polymerase chain reaction (PCR), was preferred over rapid immunology-based tests because of its higher sensitivity. But until Simplexa, molecular testing required extracting nucleic acid from the test samples, which added 60–90 minutes per test.
One of the biggest challenges for the researchers was overcoming the longstanding molecular dogma that the only way to test accurately for viruses was to extract the nucleic acid from the specimen, Exner said. “Applying an alternative approach, the R&D team at Focus Diagnostics was able to find a way to take the specimens, whether whole blood, stool samples, or throat swabs, and detect flu and other organisms directly without going through the purification step,” he explained.
The Focus Diagnostics team developed its Simplexa Direct Assays for use with the 3M (St. Paul, MN) Integrated Cycler, a compact, portable testing platform. The Simplexa assay kits use a proprietary chemical mix to neutralize inhibitors. Once the team members proved their process of releasing nucleic acids from universal transport media worked, they continued to apply the approach to other sample types, allowing them to adapt multiple existing assays into the Simplexa Direct format. These include their Influenza A, Influenza B, and respiratory syncytial virus assay. The 3M Integrated Cycler is capable of handling anywhere from eight to 96 samples per run, depending on which kit is used.
Other researchers and developers have taken the approach to “shrink the lab” into their instrument to overcome the restrictions associated with molecular diagnostic testing, embedding the extraction and not eliminating it, Exner said. “Alternatively, people have tried to prevent inhibition of PCR reactions but generally could not make it work without making a significant dilution of the specimen,” he said. “The problem with diluting the sample is that it limits the sensitivity of your test. We avoid this issue by using our modified master mix. We’ve managed to do what others have not been able to.”
Eliminating the purification process means results are available much faster, and with the Simplexa Direct Assays, it is done without sacrificing sensitivity. Positive test results can be made available in about 30 minutes; negative test results take about an hour to confirm.
Another advantage to using Simplexa Direct is that it does not require significant bench space, complicated contamination control, or expensive laboratory equipment. The 3M Integrated Cycler is a cost effective solution that requires no lab modifications to use. “Because it’s so simple, essentially anyone can do it without special training,” says Kyle Armantrout, senior director of global marketing for Focus Diagnostics. The relatively low entry costs mean the testing could become available at community hospitals and walk-in clinics, not just reference laboratories. “Plus there is a demand for this type of testing at almost any medical facility in the U.S.,” Armantrout said.
For patient care settings, rapid accurate results make a difference. If patients test positive, they can be admitted to the hospital and/or given the most effective therapy right away, said Armantrout. With a test menu featuring hospital acquired infection and respiratory infection kits, Simplexa Direct allows laboratories to run the tests in their own facilities and provide results to physicians in a timely manner so that they may be able to institute controls and treatments, and prevent further outbreaks.
According to Exner, “Normally, this type of innovation takes several years to create and design. We got lucky in that our first concept worked so well it could become a product right away.”
Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus in May 2010. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr, and BK viruses are CE marked and distributed in Europe.
Exner believes the Simplexa Direct assays are the future, and it is here. “In essence, we have universalized the chemistry enough to allow us to rapidly develop and launch multiple assays in this format,” Exner said. “I do not think we will launch another assay that requires extraction.”
SnapPath 1000 Biomarker Testing System
The SnapPath 1000 Biomarker Testing System by BioMarker Strategies (Baltimore, MD), designed by HS Design Inc. (Gladstone, NJ) and Sparton Medical Systems (Strongsville, OH), not only makes personalized medicine a reality but also takes it to the next level.
SnapPath is an automated live tumor cell–processing platform that enables next-generation predictive tests (known as Functional Signaling Profiles [FSP]) to guide drug treatment selection. FSPs reveal important information about pathway activation that enables oncologists to determine which drug therapy will work best for individual cancer patients.
Until now, said Adam Schayowitz, PhD, senior director of operations and business development for BioMarker Strategies,

SnapPath 1000 Biomrker Testing System by BioMarker Strategies
SnapPath 1000 Biomarker Testing System by BioMarker Strategies

molecular testing of solid tumors has primarily used dead, formalin-fixed cell samples. FSPs are not possible with traditional tumor processing methods. The SnapPath platform keeps the tumor cells alive so that oncologists are able to determine how they may respond to pathway stimulants (e.g., growth factors) and inhibitors (therapeutic drugs). “It’s a paradigm shift in the treatment of cancer,” Schayowitz said. “Instead of taking a picture of the tumor, we’re keeping it alive.”
SnapPath is for research use only and not used for diagnostic procedures. Cell samples are taken from patients who have already been diagnosed with solid malignant tumors, Schayowitz said.
Once the patient’s biopsy sample is obtained, it is loaded onto the SnapPath cartridge and placed in the platform for processing, which takes about 30 minutes. Processing involves dispersing the solid tissue into smaller groups of living solid tumor cells and removing the non-tumor cells from each group to facilitate analysis.
The live sample is distributed via automated fluids into multiple test chambers. The number of chambers or test wells varies depending on how many stimulants or inhibitors are available for the cancer type and need to be tested. After the live cells and the stimulants or inhibitors are incubated, they are compared against samples that were not changed in any way. With the SnapPath system, standard laboratory testing procedures can be performed for RNA, DNA, and protein analysis, Schayowitz said. The SnapPath system enables personalized medicine for patients with breast, lung, pancreatic, melanoma, colon, and other solid tumors. “It’s universally applicable to all solid tumors,” Schayowitz said.
One of the biggest design challenges, said Tor Alden, principal of HS Design, was determining the best way to harvest the cells and transfer them to the platform. “We had to work with both radiology and pathology to observe a lot of ultrasound-guided and fine needle aspiration biopsies to see how the physicians and technicians work together to transfer specimens,” Alden said.
Initially, the developers thought radiology would be the likely department to house the platform next to its ultrasound instrumentation. “But we found that the radiologists did not have the initiative nor infrastructure to maintain the instrument and reagents,” Alden explained. “We quickly found that pathology was the likely owner and established protocols for the safe transfer of the sample from radiology to pathology.” Because of this location change, the removable sample tube and transport kit were also designed to be compatible with multiple biopsy procurement techniques. The kit is preloaded with pipettes and sample tubes.
Since space is minimal in pathology labs, the system had to be designed to be as compact as possible, Alden said. “That’s why we included modules. There are four modules per station on our fully self-contained benchtop instrument. So for higher volume locations, where it might be common to have more than one patient sample in a 30-minute period, you could purchase additional modules to run the tests simultaneously,” he said. A lot of work went into the graphic LCD touchscreen interface to make sure that the technician processing the sample is easily able to match the sample with the assays and keep appropriate log files, Alden noted.
One of the most novel features of the system is that it is designed with no onboard analytics, Alden said. “Traditional IVD instrumentation has a lot of buffers, and all the assays are on board in bulk. What Biomarkers Strategies chose to do was to bring the assays to the cartridge itself, so once it is loaded onto the instrument, all the tips that make contact with the biohazards can be thrown away. There’s really no maintenance on the instrument, and it offers a great deal of flexibility.”
The system not only enables therapeutic treatment decisions to be made on the individual level but also does so in a much faster timeframe: the tissue processing occurs within minutes, and a report is generated within a few days. “Patients no longer need to wait weeks for conventional pathology reports to help guide clinical decision-making,” Schayowitz said. As a result, the healthcare system benefits as well because only those drugs that are most likely to be effective will be administered to patients, thereby saving time and money.
Development of the SnapPath system was supported by a $2.3 million Small Business Innovation Research grant from the National Cancer Institute.

Information about entering IVD products in the Medical Design Excellence Awards competition is available at the Website.
 

Beth Orenstein is a freelance writer based in Northampton, PA.


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