Microarray Rapid Test Speeds up Detection During a Legionella pneumophila Outbreak

In an outbreak of Legionnaires' disease, finding the exact source as quickly as possible is essential to preventing further infections. To date, a standard analysis takes days. Researchers at the Technical University of Munich have now developed a rapid test that achieves the same result in about 35 minutes.

Legionella are rod-shaped bacteria that can cause life-threatening pneumonia in humans. They multiply in warm water and can be dispersed into the air via cooling towers, evaporative recooling systems and hot water systems.

The most dangerous among the almost 50 species of Legionella is Legionella pneumophila. It is responsible for 80 percent of all infections. When an outbreak occurs, the source of the germs must be identified as soon as possible to prevent further infections.

Similar to a paternity test, the origin of the outbreak is confirmed when the germs in the process water of a technical system exactly match those identified in the patient. However, often numerous systems must be tested in the process, and the requisite cultivation for the test takes around ten days.

Faster detection with antibodies

Meanwhile there is a rapid test for detecting the Legionella pathogen in the clinic. It identifies compounds of Legionella in the urine of patients. "Unfortunately, this quick test serves only as a first indication and is not suitable for screening the water of technical systems," says PD Dr. Michael Seidel, head of the research group at the Chair of Analytical Chemistry and Water Chemistry of the Technical University of Munich.

The team of scientists thus developed a measuring chip in the context of the "LegioTyper" project funded by the German Federal Ministry of Education and Research. This chip not only detects the dangerous pathogen Legionella pneumophila but also identifies which of the approximately 20 subtypes is present.

Fast, inexpensive and versatile

The foil-based measuring chip uses the microarray analysis platform MCR of the Munich company GWK GmbH. Using 20 different antibodies, the system provides a complete analysis within 34 minutes.

"Compared to previous measurements, the new method not only provides a huge speed advantage," says Michael Seidel, "but is also so cheap that we can use the chip in one-time applications."

The system can be deployed for environmental hygiene as well as clinical diagnostics. In combination with a second, DNA-based method, the system can even distinguish between dead and living Legionella pathogens. This allows the success of disinfection measures to be monitored. The project participants will present their system to the public for the first time at the Analytica 2018 trade fair in Munich (Hall 3, Booth 315).

Publication:

Wunderlich, A.; Torggler, C.; Elsaesser, D.; Lück, C.; Niessner, R.; Seidel, M., Rapid quantification method for Legionella pneumophila in surface water. Analytical and Bioanalytical Chemistry 2016, 408(9), 2203-2213 - DOI: 10.1007/s00216-016-9362-x.

Kober, C.; Niessner, R.; Seidel, M. Quantification of viable and non-viable Legionella spp. by heterogeneous asymmetric recombinase polymerase amplification (haRPA) on a flow-based chemiluminescence microarray. Biosensors and Bioelectronics, 2018, 100, 49-55 (This study was made available online in 08/2017 ahead of peer-review and published February 15, 2018.)

More information:

The LegioTyper project is funded by the German Federal Ministry of Education and Research in the context of the "Civil Security - Protection against biological threats and pandemics" program. The antibodies were provided by the German Reference Laboratory for Legionella at the TU Dresden.

The microarray analysis platform MCR of the Munich company GWK GmbH is also used in a test for antibiotic residues in milk developed at the same chair: https://www.tum.de/en/about-tum/news/press-releases/detail/article/31075/

HelixBind Awarded Grant to Accelerate Development of Culture-Free Test for Bloodstream Infections

HelixBind, Inc. announced a collaboration with CARB-X, (Combating Antibiotic Resistant Bacteria Accelerator), a global partnership funding the development of promising new antibacterial products and diagnostics. The company is eligible to receive up to $2 million based on certain milestones supporting the development of a test for bloodstream infections on the company's proprietary RaPID diagnostic platform.

RaPID/BSI targets patients suspected of sepsis, a systemic inflammatory response to a bloodstream infections (BSIs). With approximately 30 million cases and 6 million deaths annually worldwide, sepsis is a global healthcare priority. Early and accurate diagnosis is vital to proper disease management as prognosis deteriorates hourly, but current diagnostic techniques relying on culture may take days for results. RaPID/BSI will provide identification of pathogens and resistance mechanisms within hours and direct from blood.

"We believe RaPID will enable clinicians to place patients on targeted antimicrobial days sooner, leading to better outcomes, reduced time in the hospital, and improved antibiotic stewardship," said Alon Singer, PhD, Founder and CEO of HelixBind.

In announcing the award, Kevin Outterson, Executive Director of CARB-X said: "HelixBind's diagnostic project is an exciting addition to the Powered by CARB-X portfolio, building the number of diagnostics in the portfolio and enhancing its diversity.  The ability to identify infections and drug-resistant bacteria in a timely manner will enable doctors to treat patients more effectively and save lives."

About CARB-X

CARB-X is one of the world's largest public-private partnership devoted to early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI).

About HelixBind, Inc.

HelixBind is a privately held company devoted to improving the diagnosis and management of invasive infections.  Its proprietary RaPID platform provides culture-free characterization of bacterial and fungal pathogens and resistance mechanisms direct from patient specimens, enabling clinicians to quickly diagnosis and monitor infection to ensure prompt and appropriate care.

An Old TB Detection Test Gets a Much-Needed Makeover

A new compound called DMN-Tre has been found to skip the errors encountered with other TB detection tests, and is more affordable, quick and versatile.

Looking for mycobacteria in sputum smears remains a common method for detecting tuberculosis (TB), especially in low resource areas. However, these tests are less sensitive and the results, less reliable. Now, by engineering a new fluorescent dye, scientists from the US may have provided a new lease of life to this antiquated method.

In a typical TB detection test, patients are asked to cough up sputum that is then spread as a thin layer on glass slides. Next, a technician adds dyes that bind to the bacteria, making them appear as coloured spots under a microscope. Two dyes, Ziehl-Neelsen and auramine, are used for this exercise.

The problem with confirming a TB infection this way is that “the dyes stain all cells with a very thick cell surface” irrespective of what kind of cells they were, explained Mireille Kamariza, an author of the new study. Because sputum contains many bacteria apart from the TB pathogen, some of these other microbes could also take up the dye and get counted as mycobacteria.

Another source of error is the destaining procedure. For identifying the microbe, it is essential to first remove the excess colour from the slides. This is achieved by rinsing the slides with a decoloriser and water to remove the unbound dye. The step called washing is usually performed multiple times to remove the background stain such that the marked bacteria become visible. But sometimes, after successive washes, some mycobacteria could also lose the stain.

The sensitivity of microscopy based tests varies between 32% and 94% depending on the skill and experience of the technician performing the test. This doesn’t bode well for disease control: TB is contagious and millions of new cases are identified every year. In 2016, 2.79 million were identified in India alone.

A new compound called DMN-Tre (short for DMN-tagged trehalose) can reduce these errors. The success of a method devised with this compound relies on the use of a sugar called trehalose as part of the dye. Only mycobacteria – and not other cells in the human body – use trehalose as fuel, and they also gorge on the dye. They then appear as fluorescent spots under a microscope, confirming a TB infection.

Part of the problem in detecting pathogens stems from the test’s design. Mycobacteria contain an oily substance in their cell walls called mycolic acid. It makes the pathogen’s outer coating unusually waxy to the extent that it impedes dye molecules from binding to this layer. As a result, mycobacteria don’t get stained.

Now, Kamariza and co. have turned this disadvantage on its head. They have tailored a dye that only fluoresces when it enters the waxy cell wall of the bacterium.

“DMN-Tre is a solvatochromic dye – it can ‘sense’ its environment,” Kamariza told The Wire. This means DMN-Tre behaves differently in different solvents. When in water, the dye will not fluoresce. But the minute it encounters a greasy environment, it starts glowing, according to Kamariza.

The researchers stumbled on the possibility of producing such a dye when they were studying trehalose and its function in mycobacteria. To understand the fate of the fuel within the pathogen, they needed tools to track the sugar. The simplest way to do this was by attaching a fluorescent molecule to a molecule of trehalose.

By tracking the sugar, they found that when trehalose molecules entered the bacteria, they became modified and added to the waxy cell wall.

“When I joined the team, I noticed that if we could modify a sugar such that it fluoresces only when inside cells, we could use it as a diagnostic biomarker for TB,” Kamariza said.

DMN serves this purpose. The thing about DMN is that its structure changes in different solvents. When in an oily environment, it contorts in such a way that it starts glowing. Kamariza and team thought that by attaching DMN to trehalose, they could ensure the DMN came in contact with the mycolic acid in the cell wall. And that when that happened, the DMN would fluoresce.

It did.

Another advantage of working with trehalose is that it is specifically used by TB pathogens and not by other microbes usually present in the human body. While some other disease-causing bacteria also utilise trehalose, they are not present in human sputum and don’t risk affecting test results.

Once DMN-Tre was synthesised, scientists tested its diagnostic efficiency against other fluorescent dyes used to detect TB.

Kamariza and co. first assessed the dye on bacterial strains grown in the lab. While DMN-Tre appeared to be very specific for mycobacteria and could stain more than 70% of them under 30 minutes, the scientists found that those strains that were growing at a faster rate also had the most intense colour under a microscope. This implied that the test could distinguish between live and dead bacteria – an ability beyond the scope of other dye-based methods.

To confirm this, they deliberately killed a group of mycobacteria by heating them, and checked if DMN-Tre still fluoresced by combining with the cell wall. It didn’t.

Similarly, when the scientists added antibiotics to the sputum sample before staining it with DMN-Tre, there was a perceptible change in the intensity of fluorescence. A period of three hours was enough to alter the staining pattern. This has many implications, especially in detecting the drug-resistant variety of TB that makes up 47% of all cases in the world.

Patients carrying multiple-drug-resistant (MDR) TB do not respond to common drugs like rifampicin. Their condition can also remain undiagnosed until the diseases has reached terminal proportions. This plagues both treatment and control strategies.

Sumona Datta, a clinical research fellow at the Imperial College London, said, “It’s not that we don’t have treatment options against the drug-resistant type of TB. But typically, such drugs are more expensive, more toxic, less powerful and take a longer duration for treating the infection.”

As a result, medical practitioners prescribe drugs to treat a drug-resistant infection only after MDR-TB has been confirmed or when patients don’t appear to respond to a combination of two or more drugs. Unfortunately, the required therapy is often administered too late to make a difference to patient health.

“That is why the new study with DMN-Tre is more exciting,” said Datta, who was not involved with the study.

Using DMN-Tre, scientists can now tell if the mycobacteria strain is resistant to certain drugs within a day, at least in theory. This is a promising and inexpensive alternative to other methods of TB detection, some of which also require sophisticated instruments and can’t be used in resource-poor settings.

“The revolutionary thing here is being able to track treatment response,” Carlton Evans, a professor of global health and Datta’s colleague at Imperial College London, told The Wire. “The greatest promise is in studying if patients respond to therapy and when they become non-infectious.”

None of the existing dyes can guide such therapeutic decisions. That the proposed technique also takes under two hours to finish and is as sensitive as auramine makes DMN-Tre particularly useful.

However, some limitations that apply to microscopy-based tests also apply to DMN-Tre testing.

For example, to be able to see the bacteria under a microscope, 1,000-10,000 bacteria are required per millilitre of sputum, according to Datta. “If this condition is not met, then a large proportion of people with true TB may still be categorised as uninfected.” So the tedious process of culturing the bacteria is still the gold standard to achieve an accurate analysis.

Further, “this test cannot detect extrapulmonary TB,” Dutta said, referring to cases where the mycobacteria are present in organs other than lungs. It has been estimated that 10-25% of TB infections worldwide are of this kind. In India, the numbers can be anywhere between 30% and 50%. In infections of this type, the bacteria do not show up in the sputum and could evade detection.

But the most pressing issue is DMN-Tre’s usability in the field. So far, the method has been tested in 16 patient samples, all of which turned up positive for TB. During the analysis, DMN-Tre staining proved to be rapid and efficient for detecting mycobacteria in patient samples without the need for multiple washing.

The results look promising to Datta but she has a few reservations. For their field analysis, the scientists first decontaminated and centrifuged the sputum samples before staining them with DMN-Tre. “Both these steps – decontamination and centrifugation – kill other bacteria more than they affect mycobacteria, and can concentrate the TB pathogen in the sample,” she explained. So this in itself adds to the test’s success by eliminating other contaminating bacteria.

But since centrifugation and decontamination both require sophisticated equipment, the method may not be as successful in settings with basic clinical resources, per Datta.

T. Jacob John, an emeritus professor at Christian Medical College, Vellore, echoed the sentiment. While he agreed that DMN-Tre has a few potential advantages over traditional staining techniques, he said that larger tests would have to be conducted, and their results evaluated against the ease of conducting them in ordinary labs at low costs. “Only if these conditions are fulfilled will this method become popular and be recommended for wider use,” he said.

Akonni Biosystems Announces Strategic Partnership with Major Chinese Diagnostics Company Righton

Akonni Biosystems Inc. and Chinese in vitro diagnostics company, Righton, announce a commercial agreement that enables Righton to sell Akonni's products for nucleic acid purification and molecular diagnostics to researchers, clinical laboratories, and hospitals in China. The products to be sold include TruTip®, Akonni's best-in-class sample preparation technology, which is low-cost and simple, yet highly effective at purifying DNA and RNA from the most difficult sample types. In addition, for diagnostic applications, Righton plans to commercialize Akonni's TruDiagnosis® system based on the proprietary TruArray® multiplexed diagnostic solutions. Righton has made an equity investment of $7.5 million USD in Akonni's series D fundraising round bringing the total investments in the Series D round to $13.9 million USD.

The two-way license agreement also grants Akonni exclusive rights to Righton's extensive molecular diagnostic product portfolio outside of China. Righton has established itself as a major player in the >$1 billion USD molecular diagnostics industry in China, with 28 CFDA-approved diagnostic tests, a well-established customer base, distribution and manufacturing infrastructure, and 2017 annual revenues exceeding 180 million RMB. Righton's established diagnostic tests utilize a combination of real-time polymerase chain reaction (PCR), next-generation sequencing (NGS) and droplet digital PCR (ddPCR) technologies, etc., focusing on applications such as Leukemia, Lymphoma and solid tumors in Oncology, and 30 different infectious diseases. They have an established customer base in more than 400 tertiary hospitals in 29 provinces in China.

"Righton has developed an impressive, well-established menu of reliable, affordable diagnostic tests and an outstanding reputation in China," said Dr. Charles Daitch, CEO of Akonni Biosystems. "We see a lot of value in their products that we believe can offer significant improvements to healthcare communities, and we are very excited for the opportunity to expand access to these products globally." Daitch pointed out that the companies share great synergies in their mission, vision, company culture, products and technologies, which both companies believe will enable them to expand their customer reach and accelerate revenue growth. The companies plan to initiate joint development projects for applications such as liquid biopsy testing in Oncology, non-invasive prenatal testing (NIPT), companion diagnostics and multiplexed panel testing for infectious diseases. "The investment from Righton provides us the financing we need to further our commercial goals outside of China, including the submission of our first US FDA application for our TruDx® 2000 platform. In addition, the partnership will lead to significant commercial revenues from China for both Akonni and Righton in the near-term," Daitch said.

Dr. Xiong Hui, founder and CEO of Righton, said, "While we have developed an extensive product portfolio and very successful business, we see a great opportunity to partner with Akonni. The attributes and flexibility of Akonni's platform, combined with its low cost, should allow us to break into a very large segment of the China market." Righton sees particular value in being able to use and adapt Akonni's products in China, highlighting that the two companies will work together on design and development, ensuring that the products meet the particular needs of Chinese customers and patients.  

Akonni believes the strategic partnership will help it achieve further cost savings in raw materials, manufacturing and production costs. "Whereas many small diagnostic companies choose to sell direct, we believe that our strongest path forward to commercialize Akonni's products and provide the most value to our customers is through a strategic partnership with an established company in China," said Michael Reinemann, Director of Business Development for Akonni. "Righton knows the customers, and the intricacies of the Chinese market segments, local geographies and regulatory and reimbursement environments, and can help us achieve a much more favorable cost of goods in a timely manner."

In addition to supporting Righton's core Oncology business, Righton will support the China launch of Akonni's highly anticipated Tuberculosis (TB) diagnostic product lines. According to the World Health Organization (WHO), despite significant improvements in TB control efforts recently, China still represents one of the largest TB burdens in the world. China has an estimated 1 million new cases of tuberculosis each year – more than any other country except India – including an estimated 63,000 cases of the highly dangerous, costly and deadly multidrug-resistant Tuberculosis (MDR-TB). China currently accounts for nearly one third of the MDR-TB globally. Akonni has invested heavily in its TB and MDR-TB diagnostic tests and is a major player in this market through grants from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), and collaborations with TB experts at Harvard University, the University of California San Diego (UCSD), and Johns Hopkins University.  

Scientists Develop Rapid Test that Determines Antibiotic Resistance

Scientists in Germany have developed a test using electric fields and Raman spectroscopy to ascertain specific antibiotic resistance of pathogens and thus enable the prescription of effective treatment.

Scientists of the Leibniz-Institute of Photonic Technologies (Leibniz-IPHT), Center for Sepsis Control and Care at the University Hospital Jena and Friedrich Schiller University are working on a faster and cheaper alternative for hitherto time-consuming pathogen diagnostics. Commenting on the benefits of the new test, Project Manager Prof. Ute Neugebauer said: “We combine light-based analytical methods with microfluidic sample processing.

With our Lab-on-a-Chip system – thus a miniaturised lab – we are able to clearly identify bacterial strains and their resistances, in less than three hours”.

Standard practices for infectious diagnostics require up to 72 hours to ensure a reliable result, owing to the small number of pathogens in a patient’s sample being below the level required to conduct tests. Analysis is therefore only possible after time-consuming cultivation; which is especially restrictive in clinical application during treatments for severe infections such as sepsis, where time is a crucial factor.

Currently, intensive physicians are confronted with an alarming dilemma between making every effort to save a patient and perpetuating the problem of antibiotic resistance. Commenting on the situation, Prof. Michael Bauer, director of the Clinic of Anesthesiology and Intensive Care at the University Hospital Jena, said:

“Far too often we have to administer broad-spectrum antibiotics ‘blindly’, because we can neither analyse pathogen nor potential resistances. Therefore, we possibly use a sledge-hammer to crack a nut. A vicious cycle that aides the development of new resistances” .

Test facilitates a speedy targeted approach

The new method from Jena provides much faster diagnosis that provides a basis for a decision of a reliable therapy. Ute Neugebauer, who works at Leibniz-IPHT and the University Hospital Jena points to tiny electrodes that are fixed on the surface of a stamp-sized chip: “Electric fields secure bacteria in a very small area”. Jena’s scientists then apply various antibiotics in different concentrations on the trapped bacteria and examine them by means of Raman spectroscopy. “This means that we irradiate the pathogens with laser light and evaluate the scattered light spectrum”, says Neugebauer.

Prof. Jürgen Popp, director of the Leibniz-IPHT and head of the Institute of Physical Chemistry of the Friedrich-Schiller University Jena, explains further: “After two hours we can already detect distinct changes in the Raman spectra. Out of these, we can derive whether the strain is resistant or sensible. At the same time, we get information on the required concentration of the antibiotic to constrain bacterial growth. This is an important diagnostic parameter that influences the success of a treatment decidedly”.

The combination of fast, light-based diagnostics and a high automation level reduces the time from sampling to result from currently 72 to just three and a half hours. “Such a fast procedure could revolutionise diagnostics of infectious diseases”, says Prof. Bettina Löffler, director of the Institute of Medical Microbiology at the University Hospital Jena. Currently, researchers are working to develop a platform for application of the test in hospitals. Another, more far reaching, aim is the further development into a cartridge-based rapid test system, to enable general practitioners to identify resistances in a fast and easy way for the first time. This will arm physicians with a powerful tool to aid their endeavours in personalised therapy and the administration of a fitting drug.

The results of the team of chemists, physicians, and biologists were published in the current edition of Analytical Chemistry.

FDA Breakthrough Device Designation for Blood Infection Test

The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i Diagnostics receiving a Breakthrough Device Designation.

While the US regulator first launched the similar Breakthrough Therapy Designation for innovative medicines six years ago, the similar fast-track for devices was formalised in late 2017.

There has been a flurry of activity from the FDA since the start of 2018, with a new AI diagnostic for diabetic retinopathy and a biodegradable patch for surgical wounds already added to the programme.

3i’s technology is called Biospectrix, and detects and identifies bacteria directly from whole blood in less than an hour – a much faster time than standard lab tests, and a technology which could help doctors intervene and provide the right treatment before the infection worsens.

Biospectrix does not require culturing and identifies a broad range of bacteria in less than 60 mins directly from the patient sample, as opposed to the 2-6 days currently needed for culture.

Faster use of an appropriate antibiotic could help cut bacteria-related deaths complications, and treatment costs.

3i Diagnostics was set up by Rajesh Krishnamurthy in February 2013, and he is now its chief technology officer (CT0). Trained in chemical engineering, he previously held senior positions at drug developers Zyngenia and ImmunoGen, and spent seven years in a leadership role at Human Genome Sciences.

“We view this diagnostic as becoming a vital part of a toolkit that can be used globally to aid physicians in making treatment-related decisions i.e. if an antibiotic is necessary and, if yes, the appropriate antibiotic to use.” said Rajesh Krishnamurthy, CTO of 3i Diagnostics, Inc.

“We’re pleased to have been granted Breakthrough Device Designation for Biospectrix and look forward to working closely with the FDA to bring this diagnostic to the market as quickly as possible to address the huge unmet need for rapid broad-range bacterial identification without culturing” said James Janicki, CEO of 3i Diagnostics.

“We see Biospectrix as being a key component of the global strategy to combat the antimicrobial crisis.”

Another benefit of the technology could be in detecting sepsis, a potentially deadly complication of an infection, often bacterial, which could be prevented by faster tests.

Data from the NHS in the UK shows that there are 44,000 deaths every year from sepsis in the UK, with 14,000 of these preventable.

37% of patients that need antibiotics for sepsis are not getting them within an hour, and recent investigations found many hospitals are not carrying out screening on all patients.

3i Diagnostics’ device is also a potential candidate for England’s new Accelerated Access pathway for “strategically important, transformative products” which will be launched in April.

U of M-Developed Tool for Rapid Infection Diagnosis Nears Commercialization

A University of Minnesota chemistry professor who has developed a method for rapidly detecting the presence of urinary tract infections said she’s launching a commercialization push for a new consumer product.

Associate Professor Valerie Pierre of the U’s College of Science and Engineering is a molecular chemist whose main work is developing new kinds of florescent metal-based “contrast agents” for imaging technologies such as PET (positron emission tomography) scanners. These new compounds, when administered to patients before the procedure, could potentially enable scanners to quickly and accurately diagnose many kinds of bacterial infections in vivo, without the need for performing time-consuming cultures.

If that work is successful, it could be a major game-changer since it now takes 48 to 72 hours for medical labs to clinically diagnose any kind of infection from bacterial cultures — including fast-moving and potentially lethal infections. The delay means doctors must now make decisions based solely on symptoms rather than actual diagnoses, inevitably leading to many unnecessary and costly prescriptions for strong antibiotics.

While Pierre and her lab colleagues at the U of M have been working on improving the diagnostic capabilities of PET scanners in recent years, their efforts have also led them onto a related entrepreneurial path for a more modest but still much-needed application – a cheap, easy-to-use diagnostic tool to rapidly diagnose urinary tract infections.

Their new product is a “dipstick”-like, urine-sampling device that could one day be available to consumers in drugstores, much like home pregnancy tests. As with the scanner technology, it uses a fluorescent, metal-based complex which “lights up” when binding to bacterial targets, but in this case is refined to detect the presence of E. coli – the cause of the vast majority of urinary tract infections – as well other kinds of bacteria, all within a matter of minutes.

The inventors said the test would also be able to determine if the bacteria found are resistant to antibiotics, and so suggest the proper kind of treatment.

Pierre told TCB there’s a major unmet need for rapid analysis of all kinds of bacterial infections, but especially so for those of the urinary tract.

“Urinary tract infections are the most common infections in the world, and they especially affect women, so you’re talking about millions of cases each year just in the United States,” she said. “It also happens to be a type of infection which is not very well-diagnosed.

“Most of the time, you call a nurse or a doctor on the phone and they will prescribe antibiotics based on the symptoms, not on actual clinical diagnostics. The reason for that is there’s really nothing out there that works that is accurate and is quick. Our goal was to do something that was just as accurate as a bacterial culture but instead of taking 48 hours, it would take five minutes.”

Her path to commercializing the device was helped along by the U of M’s Clinical and Translational Science Institute, a unit of its Academic Health Center supported through the federal National Institutes of Health and its Clinical and Translational Science Award program, which seeks to move treatments out of the lab and into the market more quickly. The institute funded Pierre’s early work on the device, advised her on how to assess the medical marketplace and supported her development of a working prototype.

Now she says the effort has reached the point where a commercialization push is imminent.

“It’s something we’re very interested in doing either in partnership with a major medical company or through establishing our own startup company,” she said. “This is something the University would very much like to push forward.”

The path they ultimately take could depend on if a CEO can be found who would be interested in leading a startup firm with a possible ground-breaking product in the diagnostics field.

“I know my limitations,” Pierre laughingly added. “I know I don’t want to be a CEO myself. I’ll stick to the science.”