Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings
To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually transmitted diseases—chlamydia and gonorrhea—at the point of care (POC).
This will be welcome news to many medical professionals, as it indicates federal regulators recognize the value of diagnostic testing in near-patient settings.
Allows Non-Laboratorian Processing at Point of Care
In 2019, binx health received FDA 510k clearance to market its binx io rapid point-of-care (POC) platform for women’s health. “The binx io platform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings … In the company’s recently completed 1,523-person, multi-center clinical study, 96% of patient samples were processed on the binx io by non-laboratorians in a POC setting,” a binx press release noted.
According to the Boston-based biotech company’s website, the binx io platform (above) combines ultra-rapid, polymerase chain reaction (PCR) amplification with binx health’s proprietary and highly sensitive electrochemical detection technology. The io instrument processes a single-use, CT/NG cartridge that contains all reagents for testing self- or clinician-collected vaginal swabs and male urine samples. No sample preparation is required. Test results are available in less than 30 minutes. (Photo copyright: binx health.)
“With ever-increasing sexually transmitted infection rates, point-of-care and CLIA-waived platforms like the binx io are essential additions to our sexually-transmitted-infection-control toolbox, which will increase accessibility and decrease the burden on traditional healthcare settings,” Barbara Van Der Pol, PhD, Professor of Medicine and Public Health at University of Alabama at Birmingham, said in a binx press release.
According to binx, the Centers for Disease Control and Prevention (CDC) estimates that one in five people in the US has a sexually-transmitted disease (STD), with an estimated 108 million Americans potentially in need of routine STD testing. Additionally, chlamydia and gonorrhea are the two most treated STDs globally.
Study Finds Binx Health POC Assay Comparable to Traditional Clinical Laboratory NAATs
Van Der Pol led a team of researchers who compared the binx io chlamydia/gonorrhea POC assay to three commercially-available nucleic acid amplification tests (NAATs). The binx-funded study, published in JAMA Network Open, analyzed swab samples from 1,523 women (53.6% with symptoms) and urine samples from 922 men (33.4% symptomatic) who presented to 11 clinics in nine cities across the US.
The molecular point-of-care assay proved on par with laboratory-based molecular diagnostics for vaginal swab samples, while male urine samples were associated with “good performance.”
For chlamydia:
Sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men.
Specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men.
For gonorrhea:
Sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men.
Specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men.
Van Der Pol told Reuters News, “The bottom line is that chlamydia and gonorrhea are still the most frequently reported notifiable diseases in the US, and it costs us in the $5 billion to $6 billion range to manage the consequences of untreated infections. Unfortunately, about 70% of women who are infected don’t have any symptoms, so they don’t know they need to be tested.”
“The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients,” said Tim Stenzel, MD, PhD (above), Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in the FDA announcement. “More convenient testing with quicker results can help patients get access to the most appropriate treatment. According to the CDC, one in five Americans are diagnosed with sexually-transmitted infections every year, which is why access to faster diagnostic results and faster, more appropriate treatments will make significant strides in combatting these infections,” he added. As point-of-care testing for specific diseases increases, clinical laboratories that process these tests may see a decrease in specimen processing orders. (Photo copyright: Duke University.)
The CLIA waiver allows binx to distribute the chlamydia/gonorrhea test to 220,000 CLIA-waived locations across the US through the company’s national commercial distribution partnership with McKesson. Obstetrician/gynecologist and primary care offices, urgent care facilities, community health clinics, STD clinics, and retail settings are all potential testing sites.
Binx says its testing platform can improve health outcomes by:
Increasing treatment compliance,
Limiting onward transmission,
Minimizing the risk of untreated conditions, and
Ensuring the right treatment is provided.
In the binx health press release, binx CEO Jeffrey Luber, JD, said, “The io instrument’s demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic, where STI [sexually-transmitted infection] prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response.”
Should Clinical Laboratories Be Concerned about POCT?
It happens often: after consulting with his or her doctor, a patient visits a clinical laboratory and leaves a specimen. The test results arrive at the doctor’s office in a few days, but the patient never returns for treatment. That is why point-of-care tests (POCTs) came to be developed in the first place. With the patient in the clinic, a positive test result means treatment can begin immediately.
As the US healthcare system continues toward more integration of care and reimbursement based on value, rather than fee-for-service, point-of-care testing enables physicians and other healthcare providers to diagnose, test, and prescribe treatment all in one visit.
Thus, it is a positive step for healthcare providers. However, clinical laboratories may view the FDA’s increasing endorsement of waived point-of-care testing as a trend that is unfavorable because it diverts specimens away from central laboratories.
There also are critics within the medical laboratory profession who point out that waived tests—often performed by individuals with little or no training in laboratory medicine—have much greater potential for an inaccurate or unreliable result, when compared to the same assay run in a complex, CLIA-certified clinical laboratory.
Dozens of Chicago-area schools were reopened with the help of an $11 COVID-19 saliva test, but the qualifications of the clinical laboratory, and whether it complied with federal regulations, were called into question
It was only a matter of time when newly-formed clinical laboratories—taking advantage of the federal government’s loosening of regulations to promote COVID-19 testing—drew the attention of state regulators and the national news media. This is what happened at New Trier High School in Winnetka, Ill.
In March, the New York Times published an article, titled, “Why Virus Tests at One Elite School Ran Afoul of Regulators.” The article highlighted the coronavirus screening program implemented at New Trier High School and suggested that “New Trier may have inadvertently violated federal regulations on testing,” adding that “the Illinois Department of Public Health (IDPH) opened an investigation into the lab.”
SafeGuard Surveillance of Brookfield, Ill., was contracted to perform the routine saliva-based testing. SafeGuard analyzed saliva samples from students, teachers, and school staff to detect the presence of the SARS-CoV-2 coronavirus. New Trier was just one of several school districts that contracted with SafeGuard for the testing, which costs $11 per test. The samples were typically processed the same day.
“This has been a really valuable safety mitigation for our district to make our staff, students, and community feel safer,” Chris McClain, Assistant Superintendent for Finance and Operations at Glenbard High School District 87, told the Chicago Tribune. “We’ve been very pleased with the program.” Glenbard also contracted with SafeGuard for the COVID-19 surveillance screening.
COVID-19 Surveillance or Screening?
Though the surveillance screening testing was working as intended for multiple Chicago areas school systems, the New York Times article called into question whether SafeGuard—which at the time lacked CLIA (Clinical Laboratory Improvement Amendments) certification—was qualified to conduct COVID-19 screening testing.
The article also alleged that SafeGuard was led by a scientist who was not qualified under the federal guidelines to run a diagnostic laboratory, and that the saliva test being used was not authorized for COVID-19 testing by the federal Food and Drug Administration (FDA).
It came down to whether SafeGuard was conducting “surveillance” testing, which does not require CLIA-certification, or “screening” which does.
SafeGuard was founded by Edward Campbell, PhD, Assistant Professor in the Department of Microbiology and Immunology at Loyola University in Chicago. Campbell, a virologist with decades of experience developing tests for HIV, “adapted a saliva-based coronavirus test last summer and first established a [COVID-19] lab for the suburban school district where he serves on the board,” Patch News reported.
Microbiologist Edward M. Campbell, PhD (above), founded SafeGuard Surveillance toward the end of 2020 after demand for COVID-19 screening he had been conducting for various local school systems increased dramatically. In January, the startup clinical laboratory was running about 25,000 tests per week, the Riverside/Brookfield Landmark reported. (Photo copyright: Loyola University.)
SafeGuard Claims It Complied with Federal Regulations
SafeGuard’s COVID-19 screening tool utilizes RT-LAMP (reverse transcription loop-mediated isothermal amplification) to look for the SARS-CoV-2 coronavirus in saliva samples. This test is less sensitive than the more commonly used polymerase chain reaction (PCR) test that uses a nasal swab to detect the virus. However, the RT-LAMP test is considered reliable, particularly in individuals with a high viral load. The RT-LAMP test also is less expensive than the PCR test, which makes it appealing for public school systems.
To use the RT-LAMP test, faculty, staff, and students spit into test tubes at home and then take the sample to their school or other drop-off location. Campbell’s lab then processes the samples.
After the New York Times article came out, both New Trier and SafeGuard denied they had done anything wrong, and that their screening program complied with government regulations for COVID-19 testing. Campbell maintained that he did not need the CLIA certification to operate his lab for testing and that SafeGuard complied with all federal regulations. Nevertheless, in March, SafeGuard applied for and received CLIA-certification to “conduct ‘screening’ testing, instead of just ‘surveillance’ testing,” Patch News reported.
“We’re doing everything we can to operate in good faith under the guidance that clearly exists,” Campbell told The Chicago Tribune.
In a statement, New Trier district officials said, “New Trier has also met with local and state health authorities to review our use of the program and they have not directed us to change our use of it. From the time the program began, New Trier has been clear that the saliva program is non-diagnostic and must be confirmed by a lab test. To suggest otherwise is false,” Patch News reported.
Surveillance Testing versus Screening
In August, the federal Centers for Medicare and Medicaid Services (CMS), which oversees CLIA labs, released guidelines that stated COVID-19 testing could be performed in clinical laboratories that were not CLIA-certified so long as patient-specific results are not reported.
This “surveillance testing” is intended to identify the disease within a population group and not diagnose individuals. If a person tests positive for COVID-19 via SafeGuard’s saliva test, the individual is directed to get an FDA-approved test to confirm the diagnosis.
“We do definitely see the value of surveillance testing and how that can be used to help schools make informed decisions about remote, in-person, or hybrid learning,” Melaney Arnold, State Public Information Officer for the Illinois Department of Public Health (IDPH) told the Chicago Tribune. She added that the IDPH wants to provide schools with the tools they need to navigate the pandemic.
Following the New York Times article about New Trier High School and SafeGuard’s COVID-19 screening program, the Illinois Department of Public Health opened an investigation into the company. However, the investigation has ended, and the state agency is not taking any further action against SafeGuard, Patch News reported.
It’s worth noting that it was the FDA’s relaxing of federal regulations that encouraged the development of startup clinical laboratories like SafeGuard in the first place. There is, apparently, a fine line between surveillance and screening, and clinical laboratories engaged in one or the other should confirm they have the required certifications.
Roche Diagnostics is part of one of the world’s leading research-oriented healthcare organizations—the Roche Group. Active in the fields of pharmaceuticals and diagnostics, Roche develops innovative products and services that address the prevention, diagnosis and treatment of diseases, thus enhancing well being and quality of life.
About Roche Diagnostics
At Roche Diagnostics, our focus is to improve the lives of patients, from research to lab tests to personalized healthcare; we touch the entire spectrum of diagnostics users. Roche Diagnostics is a member of the Roche Group, which is headquartered in Basel, Switzerland.
Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management.
Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. Roche Diagnostics’ North American headquarters, located in Indianapolis, has about 4,200 employees and is home to U.S. research and development, laboratory, manufacturing, distribution, information technology and administrative operations.
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PAML, LLC, a healthcare solutions company with a focus on diagnostic testing, is located in Spokane, WA. It is owned by two of the country’s largest healthcare systems, Providence Health & Services (PH&S) and Catholic Health Initiatives (CHI). One of the top reference laboratories in the country, PAML is also nationally recognized for their innovations in clinical diagnostics and is an industry leader in joint venture partnerships with community-based hospitals.
PAML has built its reputation and leadership position by providing a full suite of healthcare solutions to meet the specific requirements of their clients. In addition, their expertise in developing cutting-edge laboratory management systems, including state-of-the-art automation and support services has made them highly regarded in the consulting field.
PAML provides a comprehensive directory of services, including:
Reference Laboratory Services
Laboratory Outreach Program
Consulting services
Oversight and mentoring of hospital laboratory management
Management of hospital laboratories
Business Agreements Direct-to-Consumer Services
Part-owner
Joint venture partnership with the hospital
Laboratory Outreach Program
Through innovative business structures, strategies, and initiatives that address the unique challenges of the evolving outreach lab market, PAML has succeeded in developing a nationally recognized Laboratory Outreach Program that partners’ with hospitals to grow their laboratory outreach business. The program includes a set of products and services that eliminate the barriers many hospital laboratories confront when trying to develop a successful outreach program. PAML’s knowledge of the outreach business and their ability to work hand-in-hand with the hospital laboratory, as their partner, will allow them to build a profitable laboratory outreach program that can compete effectively with commercial laboratories.
Consulting Services
With over half a century of experience in the medical laboratory industry, PAML has developed substantial expertise in all areas of hospital laboratory operations. Their laboratory professionals are fluent in all facets of the business, with broad-based financial, operational, technical and regulatory knowledge. If a hospital chooses to use PAML’s Laboratory Consulting and Management Services, a team of their seasoned experts will perform a comprehensive assessment of the hospital’s laboratory operations. Once the PAML team has completed their assessment, they will provide the hospital with custom-tailored solutions for managing its laboratory operations. Through a proven system developed by their laboratory staff, PAML can increase a laboratory’s efficiency, productivity and profitability.
The content of consulting services can be customized to the client’s needs and focus of the facilities. For example, a focus on process improvement may include workflow analysis and techniques for streamlining processes, while a focus on financial improvement may include test cost analysis, evaluation of staff schedules vs. workload and review of supply purchases. PAML can also provide one- or two-day overview sessions on subjects such as Lean Lab overview for technologists, compliance basics and regulatory requirements aimed at non-technical personnel.
Our experts can work directly with a hospital’s employees to help them develop plans for implementing new processes and procedures. The progress and success of all processes that are implemented or changed are monitored with financial data and statistics provided through the laboratory and hospital’s information systems.
Oversight and Mentoring of Hospital Laboratory Management
In some cases, a hospital manager may be a new or recently promoted technologist that needs lab-specific management training. PAML can provide training and mentoring that covers budget development, tracking performance and productivity, documentation for accreditation, and developing quality assurance programs. All of these functions are critical to laboratory operations, but usually unavailable in the traditional hospital management training. PAML’s expertise in these and other subjects can reduce the time it takes for the lab manager to become effective. After initial on-site visits, mentoring can take place in person or through teleconferencing.
For both Consulting Services and Oversight, the PAML expert directs the activities of the laboratory team to ensure that the department meets the overall objectives and key indicators that are aligned with hospital or facility goals, and communicates the status of the activities to the hospital or facility administration.
Management of Hospital Laboratory
With a Hospital Management Agreement, PAML can take on the responsibility for oversight of hospital’s laboratory operations. Under this agreement, the Laboratory Manager/Director would be a PAML employee, and all other lab employees would remain employees of the hospital. PAML will manage the hospital lab to insure it meets licensing accreditation and Medicare conditions, complies with applicable laws, and meets financial and productivity expectations of the hospital. The Laboratory Manager/Director will monitor the efficiency and quality of the lab and the testing performed using mutually acceptable benchmarks. PAML will provide the hospital with regular reports of key indicators and improvements.
Joint Ventures
A joint venture outreach program can be formed between PAML and your hospital. The joint venture will provide “community-based” clinical laboratory testing services in the outreach (non-patient) laboratory testing market. 80 to 85% of the testing requested by clients will be performed in the local hospital laboratory. Keeping these tests at the local hospital is what differentiates this joint venture outreach program from other national reference laboratories.
As the managing partner of the joint venture, PAML will provide the infrastructure and technology for all pre- and post- analytical components of laboratory testing. This includes, but is not limited to: phlebotomy services, logistics management, customer support services, reporting, financial management, billing services and physician connectivity.
Benefits to your lab:
• Improved patient care and satisfaction
• Access to industry knowledge and expertise
• Professional development of lab management staff
