Dettwyler is set to retire at age 92 after a long career helping clinical laboratories with their coding and billing systems
When William Dettwyler, MT, began working in a clinical laboratory, Harry Truman was president of the United States and scientists had not yet discovered the structure of DNA. Now, as he approaches his 92nd birthday in March, he is finally ready to retire from a career that has spanned more than seven decades, from bench work as a medical laboratory technician (MLT) to assisting labs with their medical coding and medical billing challenges.
Along the way, one of his coding innovations helped the State of Oregon save substantial sums in its Medicaid program. He also helped many medical laboratories increase reimbursement by correcting their coding mistakes. This from someone who left school after eighth grade to help on his family’s farm in rural Oregon.
In an exclusive interview with Dark Daily, Dettwyler discusses his long career and offered pointers for labs on improving their coding and reimbursement procedures.
Back in the 1980s, when he began his consulting work for labs, “they were very poor at billing,” he recalled. “Hospital billing staff didn’t understand lab coding. Reference laboratories didn’t do a good job of picking the right codes or even billing all the codes. Up until around the 1970s, hospitals didn’t even have to bill individual lab procedures with CPT codes. They billed with a revenue center code for all their lab services.”
These days “people are much more sophisticated,” he notes. “There are fewer coding problems compared to what it was in the 1980s and 1990s up to the 2010s.” However, he says he still has a handful of clients who call on his expertise.
“It was not unusual to go to a large university medical center and in three days tell the CFO on my exit review that the following year their lab would bring in about a half million more in revenue, just from my coding review. But I did not reveal to them that I had only gone to the eighth grade in a little one room school and was the lone graduate in my eighth-grade class,” wrote William Dettwyler, MT (above), owner of Codus Medicus in Salem, Ore., in an article he penned for Medical Laboratory Observer. For 75 years Dettwyler worked in the clinical laboratory industry. For much of that time he helped labs all over America improve their coding and reimbursement systems. (Photo copyright: LinkedIn.)
How It All Began
Dettwyler got his first taste of lab work in the early 1950s as a teenager washing glassware for a medical laboratory technician at a local medical practice. A few years later he completed an MLT program at Oregon Institute of Technology in Klamath Falls and landed his first lab tech job at a clinic in Portland.
His entry to consulting came in the early 1970s while he was working for a medical group in Salem. “I was helping the accounting personnel with their billing and noticed that Medicaid was not paying for a common test for syphilis that I was performing,” he recalled. “I contacted Medicaid, and they told me they didn’t understand laboratory procedures.”
After that, “they started to call me frequently with laboratory questions,” he said. “It wasn’t long before they asked me to help them on a part-time basis.” He also assisted with questions related to radiology.
By 1976, Dettwyler was devoting 35 hours a week to assisting the state Medicaid agency while still working as a lab tech.
Simple Hack Ends Overpayments
One of his career highlights came around 1981, when he discovered that the agency was overpaying for some pathology and radiology procedures by as much as 200%.
“Pathologists and radiologists are paid based on whether they are performing the complete procedure—the technical component and the professional component—or just the professional component, where they interpret the results,” he explained.
When billing for just the professional component, the physicians would add two digits to the standard code, so it might come in as 88305-26. However, the state’s computer system could only accommodate a five-digit code, so the state was paying as if the providers had done everything.
“The computer techs said the software couldn’t handle a seven-digit number in a five-digit box, so I devised a way for the computer to read the equivalent of seven digits,” he recalled.
His solution was to modify the codes so that the last digit was an alphabetic character. Instead of billing for code 88305-26, the physicians would bill for 8830F, and the state would pay them correctly.
Around that time, Dettwyler also began assisting a Medicare office in Portland. This forced him to cut back on his work as a lab tech. But he still worked around 60 hours a week.
“For most of my life, I’ve worked three jobs,” he said. “Work is my hobby.” He also had a large family to support—by 1976, he and his wife had 10 kids.
Transition to Lab Consulting
In 1986, the state was facing a budget shortfall and cut its Medicaid consultants, so Dettwyler decided to seek consulting work with labs while continuing to work at the bench.
“I really liked the coding because I had very little competition,” he said. “But I wanted to keep working in the laboratory mainly to understand the problems.”
While working for the state, Dettwyler attended coding seminars and workshops. He noticed that labs were losing revenue due to poor billing practices. “They didn’t understand all the coding complexities, so they really hungered for this kind of assistance.”
But first, he had to find clients. So he partnered with another lab tech who was offering similar consulting services.
Business picked up after Dettwyler contributed an article to the trade publication Medical Laboratory Observer about his process, which he calls “procedure code verification and post payment analysis.”
“That went like gangbusters,” he said. “We started getting calls from all over the country.”
Dettwyler later split from his partner and went to work on his own.
“I would sit down with the person who was responsible for coding, usually the lab or radiology manager,” he explained. “We would go over the chargemaster and cover every procedure to make sure the code and units were correct. When I was done, I would give them a report of what codes we changed and why we changed them.”
Beginning in 1989, he signed on as a contractor for another consultancy, Health Systems Concepts on the East Coast, where he remained until 2019.
Advice to the Current Generation
What is Dettwyler’s advice for someone who wants to follow in his footsteps and assist labs with their coding? “I wouldn’t recommend it now,” he said. “There’s less need for that kind of assistance than in the past.”
However, he does find that labs still run into problems. The greatest need, he says, is in molecular diagnostics, due to the complexity of the procedures.
In addition, labs are sometimes confused by coding for therapeutic drug monitoring, in which a doctor is gauging a patient’s reaction to a therapy versus screening for substance abuse. “Those issues are often misunderstood,” he said.
Microbiology also poses coding challenges, he noted, because of the steps required to identify the pathogen and determine antibiotic susceptibility. “It requires quite a bit of additional coding,” he said. “Some labs don’t understand that they can’t just bill a code for culture and sensitivity. They have to bill for the individual portions.”
Labs that work with reference labs also have to be careful to verify codes for specific procedures. “I’ll review the codes used by reference labs and, surprisingly, they’re not always correct. Reference labs sometimes get it wrong.”
If someone does want to become a coding expert, Dettwyler suggests that “they should first have experience as a lab tech, especially in microbiology, because of the additional coding. And they should try to work with somebody who is already doing it. Then, they should work with the billing department to learn how it operates.”
He also advises clinical laboratory managers to follow the latest developments in the field by reading lab publications such as The Dark Report. “You have to do that to keep current,” he said.
Despite never completing high school, Dettwyler eventually received his GED and an associate degree. “But the degrees didn’t really help me,” he said. “Much of it was on-the-job training and keeping my eyes open and listening.”
Endemic in the Amazon region, recent spread of the disease caused the CDC to issue recommendations to travelers who develop symptoms after visiting certain countries
Anatomic pathologists, microbiologists, and clinical laboratories active in infectious disease testing will want to stay informed about the worldwide progression of the Oropouche virus. The infectious pathogen is spreading beyond the Amazon region (where it is endemic) into more populated areas—including the US—and possibly being transmitted in novel ways … including through sexual activity.
The virus primarily spreads to people through biting small flies called midges (a.k.a., no-see-ums), according to a CDC Health Alert Network (HAN) Health Advisory, which added that mosquitoes can also spread the disease.
Oropouche infections, the CDC said, are occurring in Brazil, Bolivia, Peru, Columbia, and Cuba. Cases identified in the US and Europe seem to be among travelers returning from those countries. Reported cases also include deaths in Brazil and cases of mother-to-child (vertical) transmission.
There is “an increase in Oropouche virus disease in the Americas region, originating from endemic areas in the Amazon basin and new areas in South America and the Caribbean,” CDC noted in its Health Advisory.
Though de Oliveira notes that a global outbreak is not yet expected, researchers are nevertheless raising the alarm.
“The challenge is that this is such a new disease that most clinicians—including infectious disease specialists—are not aware of it and we need to make more patients and healthcare providers aware of the disease and increase access to diagnostics so we can test for it,” said David Hamer, MD (above), infectious disease specialist and professor, global health, at Boston University School of Public Health, in an NPR article. “Over the next year, we are going to learn a lot more.” Pathologist, microbiologists, and clinical laboratories will want to keep an eye on the spread of the Oropouche virus. (Photo copyright: Boston University.)
Risks to Pregnant Women, Seniors
Research published in The Lancet Infectious Diseases estimates up to five million people in the Americas are at risk of exposure to the Oropouche virus. The authors also pointed out that cases in Brazil swelled from 261 between the years 2015 to 2022 to 7,497 by August 2024.
About 60% of people infected with Oropouche have symptoms such as fever, chills, headache, muscle aches, and joint pains, according to the CDC Health Advisory, which added that the symptoms generally appear three to 10 days after exposure.
Those with the highest risk of complications from the disease, according to the CDC, include pregnant women, those over age 65, and people with medical conditions such as:
“The geographic range expansion, in conjunction with the identification of vertical transmission and reports of deaths, has raised concerns about the broader threat this virus represents in the Americas,” an additional paper in Emerging Infectious Diseases noted.
“Healthcare providers should be aware of the risk of vertical transmission and possible adverse impacts on the fetus including fetal death or congenital abnormalities,” CDC said in an Oropouche Clinical Overview statement.
“There have been a few cases of maternal to fetal transmission, and there are four cases of congenital Oropouche infections that have been described—all of which led to microcephaly, which is a small head size,” David Hamer, MD, infectious disease specialist and professor global health, Boston University School of Public Health, told NPR.
Diagnostic Testing at Public Labs
Clinical laboratories and physicians should coordinate with state or local health departments for Oropouche virus testing and reporting.
People should consider Oropouche virus testing if they have traveled to an area with documented or suspected cases, have symptoms including fever and headache, and have tested negative for other diseases, especially dengue, according to CDC.
Taking Precautions after Sex
“This [possibility of sexual transmission] brought up more questions than answers,” Hamer told NPR, adding, “we know now is that sexual transmission could happen.”
Though no documented cases of sexual transmission have been recorded, the CDC nevertheless published updated interim guidance, “recommending that male travelers who develop Oropouche symptoms after visiting areas with Level 1 or 2 Travel Health notices for Oropouche to ‘consider using condoms or not having sex for at least 6 weeks’ from the start of their symptoms,” NPR reported.
“Because stillbirths, birth defects, and severe complications and deaths in adults have been reported, CDC is providing interim recommendations on preventing possible sexual transmission based on what we know now,” the CDC stated.
Clinical laboratory leaders working with infectious disease colleagues can help educate physicians and the community about the Oropouche virus and the need to prevent bites from midges and mosquitoes by using, for example, Environmental Protection Agency (EPA) registered insect repellant.
Diagnostics professionals will want to stay abreast of developing Oropouche cases as well as changes to or expansion of clinical laboratory testing and reported guidance.
Clinical laboratories and anatomic pathology groups should prepare for a marked increase in orders for liver disease testing
New research from Virginia Commonwealth University’s Institute for Liver Disease and Metabolic Health in Richmond shows that four out of every 10 Americans has fatty liver disease of some type, according to a news release. Forty percent of Americans is an astonishing number! The study’s findings will almost certainly lead to clinical laboratories performing more testing in support of diagnosis, treatment decision making, and patient monitoring for liver disease than currently ordered by physicians.
Hepatologist Juan Pablo Arab, MD, director of alcohol sciences at Virginia Commonwealth University (VCU), led the team that conducted the research. He noted that the driving force behind the numbers is obesity and type two diabetes.
“By 2018, federal data showed that 42% of adults had some form of fatty liver disease—higher than prior estimates,” Arab’s team told Newsmax, adding that “Hispanic adults were at especially high risk … with nearly half (47%) affected.”
“This study highlights a significant health issue that affects a large portion of the US population, and it shows that certain groups are at a higher risk. We hope these findings will guide more targeted health interventions to reduce the burden of liver disease, especially in high-risk communities,” said Juan Pablo Arab, MD (above), hepatologist with VCU’s Institute for Liver Disease and Metabolic Health, director of alcohol sciences, and lead researcher in the VCU study, in a VCU news release. These insights can be expected to lead to guidelines calling for more clinical laboratory testing associated with the diagnosis of fatty liver disease. (Photo copyright: Virginia Commonwealth University.)
“Groups at greater risk for MASLD include men, adults older than 40, individuals with health insurance, those with higher body mass index, and people with other health issues like diabetes, high blood pressure, high triglycerides, and low levels of good cholesterol. Interestingly, the study found that black individuals had the lowest risk of developing MASLD compared with other groups,” the VCU news release notes.
Fatty liver disease can also be caused by excessive alcohol consumption (called alcohol-associated liver disease or ALD) or a combination of both metabolic dysfunction and moderate-to-high alcohol intake, which is called MetALD, Newsmax reported.
“Although MASLD was the most common type of liver disease found in this study, the researchers also uncovered substantial rates of MetALD and alcohol-associated liver disease. For MetALD, the study showed that men and individuals with a higher BMI [body mass index] were at a greater risk, and Asians were at lower risk. Surprisingly, the only factor that appeared to lower the risk of ALD was having health insurance, though the reasons for this are not clear,” according to the VCU news release.
On its website, Mayo Clinic notes that NAFLD is often symptomless, and that doctors typically depend on routine clinical laboratory blood test results to reach a diagnosis. Additional testing helps determine whether higher than normal liver enzymes are actually from fatty liver disease or some other condition.
Medical laboratories play a key role in facilitating the final diagnoses. According to Mayo Clinic, blood tests to identify liver disease include:
Medical imaging could also be required to reach a diagnosis, beginning with an abdominal ultrasound, Mayo Clinic added. Additionally, more precise tests may be ordered to determine the stiffness of the liver and likelihood of scarring or fibrosis. Those modalities include:
Labs will often perform these tests on the same patient multiple times as the patient’s lifestyle changes. A liver biopsy may also be required to determine severity of damage, Mayo Clinic added.
abdominal pain, spider-like blood vessels, yellowing of the skin and eyes (jaundice), itching, fluid buildup and swelling of the legs (edema) and abdomen (ascites), and mental confusion,” the ALF added.
As more healthcare providers focus their attention on diagnosing and treating this potentially deadly disease, clinical laboratories and anatomical pathology groups will likely see an uptick in tests ordered by doctors moving from initial diagnoses to more detailed testing and eventually to treatment follow ups.
Clinical laboratories are particularly tasty targets for cybercriminals seeking the abundance of protect health information contained in patient electronic health records
Recent data from cybersecurity company Netwrix of Frisco, Texas, shows that 84% of healthcare organizations—including clinical laboratories and pathology groups—caught at least one cyberattack in the past year and “69% of them faced financial damage as a result.” That’s according to the company’s latest Hybrid Security Trends Report which notes that 24% of healthcare organizations are “fully cloud-based,” as opposed to just 11% of non-healthcare industries.
“Phishing was the most common type of incident experienced on premises, similar to other industries. Account compromise topped the list for cloud attacks: 74% of healthcare organizations that spotted a cyberattack reported user or admin account compromise,” the Netwrix report notes.
Phishing, where cybercriminals send fake emails and texts to unsuspecting employees that trick them into providing private information, continues to be one of the most prevalent cyberthreats experienced by healthcare organizations and often serves as the catalyst for much larger and more dangerous cyberattacks.
This is particularly dangerous in clinical laboratories where as much as 80% of protected health information (PHI) in patients’ electronic health records (EHRs) is laboratory test results and other personal medical data.
“Protected health information (PHI) is one of the most expensive types of data sold on darknet forums, which makes healthcare organizations a top target for cybercriminals, said Ilia Sotnikov (above), security strategist and VP of user experience at Netwrix, in the report. Clinical laboratory patient electronic health records are particularly weighted toward PHI. (Photo copyright: Netwrix.)
Don’t Open That Email!
Typical phishing scams begin with innocent-looking emails from companies that appear to be legitimate and often contain language that implies urgent action is needed on the part of the user. These emails can be very convincing, appear to originate from reputable companies, and usually instruct users to open an attachment contained in the email or click on a link that goes to a known company website. However, the site is a fake.
Once the harmful file attachment is opened, users will be directed to download fake software or ransomware that attempts to capture the user’s personal information. When visiting a malicious website, consumers will often receive pop-ups with instructions for updating information, but the true purpose is to harvest personal data.
Never provide any personal information to an unsolicited request.
If you believe the contact is legitimate, initiate a contact with the organization using verified data, usually via telephone.
Never provide any passwords over the phone or in response to an unsolicited Internet request.
Review any accounts, such as bank statements, often to search for any suspicious activity.
“Healthcare workers regularly communicate with many people they do not know—patients, laboratory assistants, external auditors and more—so properly vetting every message is a huge burden,” said IT security expert Dirk Schrader, VP of security research at Netwrix, in the report. “Plus, they do not realize how critical it is to be cautious, since security awareness training often takes a back seat to the urgent work of taking care of patients. Combined, these factors can lead to a higher rate of security incidents.”
Top 10 Brands Faked in Phishing Scams
Phishing emails often appear to be from legitimate companies to lull the recipient into a false sense of security. In a January 22 report, Check Point Research (CPR) announced its latest Brand Phishing Ranking for the fourth quarter of 2024. The report reveals the brands that were most frequently impersonated in phishing attacks by cybercriminals for the purpose of stealing personal information from consumers.
According to the CPR report, 80% of disclosed brand phishing incidents occurred within just 10 brands (listed below with each brand’s percentage of phishing attacks). They are:
According to the report, fraudulent domains “replicated official websites to mislead shoppers with fake discounts, ultimately stealing login credentials and personal information. These fraudulent sites replicate the brand’s logo and offer unrealistically low prices to lure victims. Their goal is to trick users into sharing sensitive information, such as login credentials and personal details, enabling hackers to steal their data effectively.”
Steps Clinical Labs Can Take to Protect Patients’ PHI
Clinical laboratories and pathology groups can take precautions that minimize the risk of allowing cybercriminals access to their patients’ PHI.
“A core defense strategy is to minimize standing privileges by using a privileged access management (PAM) solution. Another is to implement identity threat detection and response (IDTR) tools to quickly block malicious actors using compromised credentials,” said Ilia Sotnikov, security strategist and VP of user experience at Netwrix, in the report.
The threat of phishing scams is a lingering issue that everyone in healthcare should be aware of and take necessary precautions to recognize and prevent having one’s PHI stolen. Clinical laboratory management should constantly remind lab personnel and contractors to be vigilant regarding fake emails and texts from well-known brands that ask for private information.
Legal actions highlight ongoing concerns about payer behavior and included a record-breaking settlement in antitrust case against Blue Cross and Blue Shield
Several high-profile federal lawsuits filed last year, along with settlements in older cases, demonstrate that providers, patients, and self-insured employers—including hospitals, clinical laboratories, and anatomic pathology groups—continue to have serious concerns about lack of transparency and certain business practices of health plans.
Self-Insured employers are suing because they cannot see their data and discovered their health plans overpaid providers from allowed charges (meaning a self-insured employer has greater health benefit costs).
Providers are suing because they are being paid less than agreed and have claims denied for spurious reasons.
These lawsuits show that there is increasing ill will and concerns by self-insured employers and providers as to how health insurers are properly conducting business.
Below is a rundown of the cases.
“Over the past 12 years we have dedicated an extraordinary amount of time, tireless effort, and resources to this historic outcome for providers,” said Co-Lead Counsel Edith Kallas, JD, of Whatley Kallas, a press release. The Blue Cross and Blue Shield Association settlement with healthcare providers is the largest healthcare-related antitrust settlement in US history, according to plaintiff’s attorney Whatley Kallas, LLP. Clinical laboratories and pathology groups can learn from these lawsuits. (Photo copyright: Whatley Kallas.)
BCBSA Settles Long-Running Antitrust Case
In October, the Blue Cross and Blue Shield Association (BCBSA) and the 33 independent Blue Cross and Blue Shield (BCBS) plans agreed to a $2.8 billion settlement in a 12-year-old federal antitrust lawsuit. Co-counsel for the plaintiffs Whatley Kallas, LLP, described the agreement as the “largest antitrust settlement in the history of the United States healthcare industry.”
Healthcare providers alleged that the BCBS plans had agreed “to allocate markets through the use of exclusive service areas and to fix the prices paid to providers through the BlueCard Program,” according to a news release.
In addition to the cash payment, the health plans also agreed to “invest hundreds of millions of dollars in system improvements for the benefit of providers,” the law firm noted, adding that the settlement would compel changes in how the plans “process claims, communicate with, and make payments to healthcare providers,” helping to “address resource-draining administrative burdens and inefficiencies currently experienced by providers.”
Whatley Kallas said the settlement would ultimately result in injunctive relief amounting to $17.3 billion during its first 10 years.
“Many important issues for providers are finally being addressed,” said Edith Kallas, JD, of Whatley Kallas in the news release. “We’re pleased that we have been able to achieve relief that will create a better system for healthcare providers and that will support the organizations and people we rely on to take care of us and our families every day.”
BCBSA also issued a statement: “This settlement ends a long-running legal challenge to the Blue Cross Blue Shield Association license agreements and related rules. We deny the allegations made in the lawsuit. However, to reach a settlement and put years of litigation behind us, we have agreed to make some operational changes and a monetary payment to the provider class involved in the case.”
As explained in court documents, plaintiff Sandra M. Peters was covered by an ERISA plan self-funded by Mars Inc. and administered by Aetna. The latter contracted with Optum to provide access to physical therapy, occupational therapy, and chiropractic services.
Peters alleged that Aetna, in collusion with Optum, fraudulently disguised the latter’s administrative fees as medical costs.
“These misrepresentations serve as the cover that allows Aetna to illegally (i) obtain payment of the Subcontractors’ administrative fees directly from insureds when the insureds’ deductibles have not been reached; (ii) use insureds’ health spending accounts to pay for these fees; (iii) inflate insureds’ co-insurance obligations using administrative fees; (iv) artificially reduce the amount of available coverage for medical services when such coverage is subject to an annual cap; and (v) obtain payment of the administrative fees directly from employers when an insured’s deductible has been exhausted or is inapplicable,” stated her original complaint, filed in 2015 in the US District Court for the Western District of North Carolina.
On Nov. 6, attorneys for Peters notified the court that they had settled the case. A month later, Optum said it had withdrawn from the settlement and was prepared to go to trial. Then, the parties appeared to resolve their remaining differences, and Peters’ attorneys filed notice on Dec. 17 that they had once again settled, Mealey’s reported. Terms of the settlement were not disclosed.
Owens and Minor Alleges Mismanagement of Self-Funded Plan
As reported by The Dark Report and various news outlets, Owens and Minor, a healthcare logistics company, filed a lawsuit in November against Anthem BCBS of Virginia, which had been administering Owens’ self-funded employee health plan since 2017.
The complaint further stated that “Defendant acted contrary to the fiduciary standards imposed by ERISA by, among other things, (i) paying more for healthcare claims than was even billed, (ii) securing kickbacks from providers, (iii) double-paying claims, and (iv) pocketing rebates belonging to Plaintiff.”
Owens initially requested plan data from Anthem in September 2021, but Anthem refused to do so, the complaint stated. “Eventually, Plaintiff had to sue Defendant to obtain its own data. Now that Plaintiff has a portion of that Plan data and has had the opportunity to analyze it, it is clear why Defendant fought so hard to prevent Plaintiff from accessing it.”
Becker’s Payer Issues noted that the lawsuit “reflects a wider legal trend for employers and health plan administrators navigating ERISA requirements. Under the law, plan fiduciaries must act in the best interests of beneficiaries by seeking the lowest reasonable costs for services. Recent amendments, such as the Consolidated Appropriations Act of 2021, have heightened transparency requirements, leaving employers with new tools—and new pressures—to ensure compliance.”
DOJ Alleges Overcharges Related to Military Managed Care
On March 13, the US Department of Justice (DOJ) announced that it had sued six health plans that participate in the Uniformed Services Family Health Plan (USFHP) program, which provides health benefits to military retirees and their families. The government alleged that the plans were aware of calculation errors that had inflated payment rates by more than $300 million between 2008 and 2012.
“The Plans failed to report or return any of those overpayments and, in fact, continued submitting claims to the government at the improperly inflated rates for several more months,” the complaint states.
Shortly after filing the lawsuit, US Family Health Plan Alliance issued a statement describing the allegations as “meritless,” Becker’s Payer Issues reported. The group said that the plans and the government had “expressly negotiated [payment rates] in a fixed-rate contract more than 10 years ago.”
These developments are clear signals in the market that self-insured employers, along with providers—including physicians, hospitals, and medical laboratories—have growing evidence that certain health insurance companies are gaming the system and not paying claims according to contractual arrangements. Expect to see more lawsuits against health plans, particularly by self-insured employers because, for them, the sums involved can be in the tens of millions of dollars.
Innovative in-office test, when integrated with UTI microbiology testing performed by clinical laboratories, could contribute to better patient outcomes
Treatments for certain bacterial infections are becoming less effective due to antimicrobial resistance (AMR). Now, after a 10-year-long worldwide competition, the first multi-million euro prize for an accurate, rapid, and cost effective clinical laboratory test for diagnosing and treating urinary tract infections (UTIs) went to Sysmex Corporation’s subsidiary Astrego. This milestone event could benefit tens of millions of people who suffer from UTIs annually.
Astrego, of Uppsala, Sweden, won the €8 million (US$8.19 million) Longitude Prize on AMR for its PA-100 AST System. The new diagnostic technology will “transform treatment of urinary tract infections and brings the power of clinical laboratory testing into a doctor’s office,” according to a news release from Challenges Works, the United Kingdom-based organization that organized and awarded the prize.
The Astrego system is, according to Challenge Works’ website, a “game-changing solution” in “a novel point-of-care diagnostic test that rapidly and accurately identifies the presence of a bacterial infection and the right antibiotic to prescribe.”
“We launched the Longitude Prize on AMR (in 2014) to create the urgent ‘pull’ needed to get innovators working on one of the biggest life-and-death challenges facing humanity. Hundreds of teams [that] competed with multiple solutions [are] now close to market thanks to the prize,” said Tris Dyson, Managing Director, Challenge Works, in a news release.
The new diagnostic technology “could herald a ‘sea change’ in antibiotic use” according to the judges of the competition, The Guardian reported.
“The PA-100 AST System (above) creates a future where patients can quickly and accurately get a diagnosis and the correct treatment when they visit the doctor,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Accurate, rapid diagnosis of bacterial infections that help doctors and health workers to manage and target antibiotics, will slow the development and spread of antibiotic resistant infections, improve healthcare and save potentially millions of lives,” she added. In-office point-of-care systems like the PA-100 may reduce the number of doctor orders for UTI tests to clinical laboratories while contributing to better patient outcomes. (Photo copyright: Sysmex.)
How the Test Works
In the UK, people are treated for UTIs more than any other infection. It takes about three days for doctors to receive the results from traditional microbiology testing. They then prescribe an antibiotic to treat the infection. But about half of “infection-causing bacteria are resistant to at least one antibiotic,” according to a news release from the Geneva, Switzerland-based NESTA Foundation which funded the Longitude Prize on AMR.
“It’s impossible to overstate how critical it is to address AMR [antimicrobial resistance]. By 2050, it is predicted to cause 10 million deaths a year—matching those caused by cancer—and cost $1 trillion in additional health costs,” the news release states.
UTI are more common in women and the reason for eight million healthcare appointments annually in the US, according to Medscape.
The PA-100 AST system makes it possible for patients to provide a small urine sample during their appointments with doctors, find out if they have a bacterial infection in 15 minutes, and receive the “right antibiotic to treat it within 45 minutes,” NESTA said. Sysmex describes the PA-100 AST as an “automated phenotypic analyzer, based on EUCAST standards,” that combines “phase-contrast microscopy and nanofluidics to make available antibiograms at point of care.” It enables healthcare providers to perform antimicrobial susceptibility testing (AST) in-office rather than sending out urine samples to microbiology laboratories.
The systems works as follows, according to the Sysmex website:
As a urine sample passes through the chip, “single bacterial cells are trapped in individual channels.”
Meanwhile, “larger cellular components” are filtered and kept out of the nanofluidic chip.
Contrast-phase microscopy enables real-time monitoring of cell growth. “Resistant bacteria keep a higher growth rate during incubation, while susceptible ones grow slowly or lyse.”
Expert computer software identifies that bacterial strain, delivers an “easy to interpret antibiogram after assay completion” and provides an “informed prescription decision” on which antibiotic is expected to fight the infection.
“The PA-100 AST System challenges bacteria present in a patient’s urine with microscopic quantities of antibiotics in tiny channels embedded in a cartridge the size of a smartphone,” said Mikael Olsson, CEO and co-founder of Sysmex Astrego, in The Microbiologist.
“We rapidly pinpoint whether a bacterial infection is present and identify which antibiotic will actually kill the bugs, guiding doctors only to prescribe antibiotics that will be effective,” he added.
Sysmex is conducting more studies in the UK and working with regulators in Europe for clearances, according to Olsson.
Older Antibiotics May Make Comeback
It’s possible that use of the PA-100 system to identify the best antibiotic to treat infections could lead to a resurgence in the use of previously retired antibiotics.
“Roughly 25-30% of patients have infections resistant to older first-line antibiotics which have been retired as a result; this means the remaining 70-75% of patients could still benefit from those older drugs,” Pathology in Practice reported, adding, “Since the PA-100 AST System identifies which specific antibiotic can treat an infection, it will likely allow retired antibiotics to be brought back into service because the test is able to demonstrate when an infection is susceptible to their effects.”
Many people could benefit from the older antibiotics, Challenge Works noted.
Revolutionizing Healthcare
The Sysmex Astrego’s PA-100 AST System is a significant development.
“Currently, I send the urine sample off for analysis, and it usually takes around three days to come back with results,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Having a bedside test that would enable rapid diagnosis through antibiotic susceptibility testing would revolutionize general practice and patient care. It’s all about using antibiotics only when necessary and appropriate.”
Each individual test costs about €25 (US$25.72), The Guardian reported, adding that ramped up production may lower the price.
The PA-100 AST System is the latest example of a diagnostic/therapeutic solution developed in Europe rather than the US, which is often slower to award regulatory clearance.
It also is another test that will be performed outside of traditional clinical laboratory settings, demonstrating the trend to move medical laboratory tests closer to patients.