FDA says the move will make it easier to gain authorization for other clinical laboratory tests to utilize at-home collection kits
In another sign of how diagnostic testing is responding to changing consumer preferences, the US Food and Drug Administration (FDA) granted marketing authorization to LetsGetChecked for the company’s Simple 2 test for chlamydia and gonorrhea, which includes at-home collection of samples sent to the test developer’s clinical laboratories in the US and in Ireland.
This marks the first time the FDA has cleared a diagnostic test for either condition in which samples are collected at home. It’s also the first test with at-home sample collection to be authorized for any sexually transmitted infection (STI) other than HIV, the FDA said in a new release.
Samples are collected through a vaginal swab or urine sample. “Results are delivered online in approximately 2-5 days with follow-up virtual consultations and treatment available if needed,” the company press release states.
Previously authorized tests for the conditions required sample collection at the point of care. The company also offers telehealth and online pharmacy services.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD (above), Director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more healthcare into the home.” With this emphasis on at-home testing from the FDA, clinical laboratories in the US and Ireland will likely be processing more at-home collected samples. (Photo copyright: FDA.)
Simple 2 Process and Costs
Prior to collecting the sample, the user goes online to complete a questionnaire and activate the kit, the FDA news release notes.
LetsGetChecked, headquartered in New York City and Dublin, Ireland, says its US labs are CLIA– and CAP-certified. The company currently offers more than 30 at-home tests covering STIs, men’s health, women’s health, and COVID-19, at prices ranging from $89 to $249 per test.
The Simple 2 test costs $99, and is not covered by insurance, Verywell Health reported. Consumers can get discounts by subscribing to quarterly, semiannual, or annual tests.
New Regulatory Pathway
The FDA said it reviewed the test under its De Novo regulatory pathway, which is intended for “low- to moderate-risk devices of a new type,” according to the news release.
“Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing,” the agency stated. “When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.”
This creates a new regulatory classification, the agency said, that will make it easier for similar devices to obtain marketing authorization.
Citing data from the federal Centers for Disease Control and Prevention (CDC), the FDA news release states that chlamydia and gonorrhea are the most common bacterial STIs in the US. The CDC estimates that there were 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021.
“Typically, both infections can be easily treated, but if left untreated, both infections can cause serious health complications for patients, including infertility,” the news release states. “Expanding the availability of STI testing can help patients get quicker results and access to the most appropriate treatment, ultimately helping to curb the rising rates of STIs.”
Experts Praise the FDA’s Authorization of the Lab Test
STI experts contacted by STAT said they welcomed the FDA’s move.
“There are many people who would like to be tested for STIs who may not know where to go or who have barriers to accessing medical care,” said Jodie Dionne, MD, Associate Professor of Medicine in the University of Alabama at Birmingham (UAB) Division of Infectious Diseases. “If we are going to do a better job of reaching more sexually active people for STIs … we need to be creative about how to get them tested and treated in a way that is highly effective and works for them.”
Family physician Alan Katz, MD, a professor at the University of Hawaii John A Burns School of Medicine, told STAT that the Hologic assay is also used by clinicians who treat people in remote locations to diagnose STIs and is regarded as being highly accurate.
“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” he told STAT.
With this latest move, the FDA is recognizing that it is time to give consumers more control over their healthcare. This is a signal to clinical laboratories that they should be developing their own strategies and offerings that serve consumers who want to order their own tests. Of course, many states still require a physician’s signature on lab test orders, but that is likely to change over time.
McGonnagle’s involvement with medical laboratory medicine spans five decades and 38 years of support for the nation’s anatomic pathologists and clinical laboratory professionals
The presentation was made in front of 950 attendees. During the presentation, several of McGonnagle’s peers described the multiple ways that he regularly supports the profession of clinical laboratory medicine.
In 1986, McGonnagle was engaged by the College of American Pathologists (CAP) to develop the concept of a new, tabloid-sized, color magazine to be called CAP Today. It was January 1987 when monthly publication of CAP Today formally commenced.
McGonnagle was again tapped by CAP to oversee production of another publication that was created in 1996. Since its inception, he has also been publisher of the Archives of Pathology and Laboratory Medicine.
During last week’s Executive War College on Diagnostic, Laboratory, and Pathology Management in New Orleans, Bob McGonnagle (center right) was honored with a Lifetime Achievement Award for his 38 years as Publisher of CAP Today, along with his innumerable contributions to advancing the clinical laboratory and anatomic pathology professions. McGonnagle is joined by Robert Michel, founder of the Executive War College on his right; Al Lui, MD, of Innovative Pathology Medical Group on his far right; and Stan Schofield of Compass Group on his left. (Photo copyright: The Dark Report.)
38 Years as Publisher of CAP Today Magazine
But McGonnagle’s duties as publisher are just the starting point of the contributions McGonnagle has made to the House of Laboratory Medicine in the past 38 years. He is regularly seen at pathology and lab meetings, conferences, and workshops throughout the United States and overseas. As a speaker and moderator, he is much in demand. He is often asked to sit in during strategic retreats and think tanks organized by laboratory associations, lab organizations, and lab vendors.
During the presentation ceremony, three of McGonnagle’s peers offered insights and examples of his unstinting support of pathologists, lab managers, and companies serving medical laboratories. First to speak was Stan Schofield, Managing Principal at Compass Group and past CEO of NorDx Laboratories in Scarborough, Maine.
“Bob McGonnagle is excellent as a moderator for conferences, meetings, and conventions and will always say ‘yes’ when asked to serve,” Schofield observed. “He is quick to recognize and adapt to emerging issues. He processes information from various parts of the lab industry, then generates insights and information all can understand and use to the benefit of their respective labs and pathology groups.”
Next to speak was pathologist Al Lui, MD, President and Medical Director, at Innovative Pathology Medical Group in Torrance, California. Lui has been active on committees and initiatives of CAP for decades. “Recognition of Bob McGonnagle’s past and continuing contributions to the profession of pathology and laboratory medicine is long overdue,” he said.
McGonnagle as Farmer, Fan of Classical Music, and Oenophile
Lui then presented slides that showed the range of McGonnagle’s activities outside of his publishing responsibilities. For example, Bob is remote manager of two inherited family farms in Iowa that produce corn, soybeans, and cattle. His wife competes in equestrian events. They are wine aficionados and close personal friends with one of Napa Valley’s most respected vintners.
One key figure in McGonnagle’s publishing activities is the Editor of CAP TodaySherrie Rice. She has served in this role since 1987 and thus has collaborated with Bob for the 38 years of CAP Today’s publication. “His leadership of the periodicals department at the CAP has been brilliant and working alongside him for more than three decades has been the gift of a lifetime,” Rice noted.
Rice also described an underappreciated aspect of McGonnagle’s efforts as Publisher. “Bob constantly works to connect the IVD manufacturers and lab vendors with labs that need and benefit from these solutions,” she noted. “He is quick to recognize emerging technologies and help explain them with in-depth stories in CAP Today that help pathologists and lab managers better understand when such innovations are ready to be implemented.”
A Career That Spans Five Decades
As McGonnagle was handed his Lifetime Achievement Award, Robert Michel, Founder of the Executive War College and Editor-in-Chief of Dark Daily and its sister publication The Dark Report, made several observations. “Bob McGonnagle has all the hallmarks of a loyal friend. He is always willing to help and never asks for anything in return,” Michel noted. “He is discreet and trustworthy, with keen powers of observation and analysis. Our profession is blessed that his career and contributions have spanned five decades.”
All of Bob McGonnagle’s colleagues, friends, and associates are encouraged to use social media to send him congratulations and notes of appreciation for his 38 years of service as Publisher of CAP Today, and for his many contributions to the clinical laboratory and pathology professions.
Here are social media links where it would be appropriate to post comments about Bob McGonnagle, with best wishes, congratulations, and examples of his selfless support:
But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate committees urging passage of legislation that would enable some regulation of LDTs, the VALID Act was ultimately omitted from the year-end omnibus spending bill (H.R. 2617).
That may be due to pressure from organizations representing clinical laboratories and pathologists which lobbied hard against the bill.
Responding to criticism of its stance on FDA oversight of LDTs, in a May 2022 open letter posted on the organization’s website, anatomic pathologist and CAP president Emily Volk, MD, said “we at the CAP have an honest difference of opinion with some other respected laboratory organizations. … We believe the VALID Act is the only viable piece of legislation addressing the LDT issue. … the VALID Act contains many provisions that are similar to policy the CAP has advocated for regarding the regulation of laboratory tests since 2009. Importantly, the current version includes explicit protections for pathologists and our ability to practice medicine without infringement from the Food and Drug Administration (FDA).” (Photo copyright: College of American Pathologists.)
Organizations on Both Sides Brought Pressure to Bear on Legislators
The AAMC and AMP were especially influential, Bucshon told ProPublica. In addition to spending hefty sums on lobbying, AMP urged its members to contact legislators directly and provided talking points, ProPublica reported.
“The academic medical centers and big medical centers are in every state,” Bucshon said. As major employers in many locales, they have “a pretty big voice,” he added.
Discussing CAP’s reasoning behind its support of the VALID Act in a May 26 open letter and podcast, CAP president Emily Volk, MD, said the Valid Act “creates a risk-based system of oversight utilizing three tiers—low, moderate and high risk—in order to target the attention of the FDA oversight.”
While acknowledging that it had room for improvement, she lauded the bill’s three-tier risk-based system, in which tests deemed to have the greatest risks would receive the highest level of scrutiny.
She also noted that the bill exempts existing LDTs from an FDA premarket review “unless there is a safety concern for patients.” It would also exempt “low-volume tests, modified tests, manual interpretation tests, and humanitarian tests,” she wrote.
In addition, the bill would “direct the FDA not to create regulations that are duplicative of regulation under CLIA,” she noted, and “would require the FDA to conduct public hearings on LDT oversight.”
Pros and Cons of the VALID Act
One concern raised by opponents relates to how the VALID Act addressed user fees paid by clinical laboratories to fund FDA compliance activities. But Volk wrote that any specific fees “would need to be approved by Congress in a future FDA user fee authorization bill after years of public input.”
During the May 2022 podcast, Volk also cast CAP’s support as a matter of recognizing political realities.
“We understand that support for FDA oversight of laboratory-developed tests or IVCTs is present on both sides of the aisle and in both houses of Congress,” she said. “In fact, it enjoys wide support among very influential patient advocacy groups.” These groups “are very sophisticated in their understanding of the issues with laboratory-developed tests, and they do have the ear of Congress. There are many in the laboratory community that believe the VALID Act goes too far, but I can tell you that many of these patient groups don’t believe it goes far enough and are actively pushing for even more restrictive paradigms.”
Also urging passage of the bill were former FDA commissioners Scott Gottlieb, MD, and Mark B. McClellan, MD, PhD. In a Dec. 5 opinion piece for STAT, they noted that “diagnostic technologies have undergone considerable advances in recent decades, owing to innovation in fields like genomics, proteomics, and data science.” However, they wrote, laws governing FDA oversight “have not kept pace,” placing the agency in a position of regulating tests based on where they are made—in a medical laboratory or by a manufacturer—instead of their “distinctive complexity or potential risks.”
In their May 22 letter, opponents of the legislation outlined broad areas of concern. They contended that it would create “an onerous and complex system that would radically alter the way that laboratory testing is regulated to the detriment of patient care.” And even though existing tests would be largely exempted from oversight, “the utility of these tests would diminish over time as the VALID Act puts overly restrictive constraints on how they can be modified.”
CLIA Regulation of LDTs also Under Scrutiny
The provision to avoid duplication with the Clinical Laboratory Improvement Amendments (CLIA) program—which currently has some regulatory oversight of LDTs and IVCTs—is “insufficient,” opponents added, “especially when other aspects of the legislation call for requirements and activities that lead to duplicative and unnecessary regulatory burden.”
Opponents to the VALID Act also argued that the definitions of high-, medium-, and low-risk test categories lacked clarity, stating that “the newly created definition of moderate risk appears to overlap with the definition of high risk.”
The opponents also took issue with the degree of discretion that the bill grants to the US Secretary of Health and Human Services. This will create “an unpredictable regulatory process and ambiguities in the significance of the policy,” they wrote, while urging the Senate committee to “narrow the discretion so that stakeholders may better evaluate and understand the implications of this legislation.”
Decades ago, clinical laboratory researchers were allowed to develop assays in tandem with clinicians that were intended to provide accurate diagnoses, earlier detection of disease, and help guide selection of therapies. Since the 1990s, however, an industry of investor-funded laboratory companies have brought proprietary LDTs to the national market. Many recognize that this falls outside the government’s original intent for encouragement of laboratory-developed tests to begin with.
Factors contributing to shortage of med techs and other lab scientists include limited training programs in clinical laboratory science, pay disparity, and staff retention, notes infectious disease specialist Judy Stone, MD
Staff shortages are a growing challenge for medical laboratories, and now the problem has grabbed the attention of a major media outlet.
In a story she penned for Forbes, titled, “We’re Facing a Critical Shortage of Medical Laboratory Professionals,” senior contributor and infectious disease specialist Judy Stone, MD, wrote, “Behind the scenes at every hospital are indispensable medical laboratory professionals. They performed an estimated 13 billion laboratory tests in the United States each year before COVID. Since the pandemic began, they have also conducted almost 997 million diagnostic tests for COVID-19. The accuracy and timeliness of lab tests are critically important, as they shape approximately two-thirds of all medical decisions made by physicians.”
Though Stone states in her Forbes article that clinical laboratories in both the US and Canada are facing staff shortages, she notes that the problem is more acute in the US.
As Dark Daily reported in February, the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to the nation’s network of clinical laboratories.
In her analysis, however, Stone accurately observes that the problem pre-dates the pandemic. For examples she cites two surveys conducted in 2018 by the American Society for Clinical Pathology (ASCP):
Many pathologists and clinical laboratory managers would agree that Stone is right. Dark Daily has repeatedly reported on growing staff shortages at clinical laboratories worldwide.
And in “Lab Staffing Shortages Reaching Dire Levels,” Dark Daily’s sister publication, The Dark Report, noted that CAP Today had characterized the current lab staffing shortage as going “from simmer to rolling boil” and that demand for medical technologists and other certified laboratory scientists far exceeds the supply. Consequently, many labs now use overtime and temp workers to handle daily testing, a strategy that has led to staff burnout and more turnover.
“There is a critical shortage of medical laboratory professionals in the US, and in Canada to a lesser extent,” wrote infectious disease specialist Judy Stone, MD (above), in an article she penned for Forbes. “Here [in the US],” she added, “we are 20-25,000 short on staff, with only 337,800 practicing. That is roughly one medical laboratory scientist per 1,000 people.” Clinical laboratories are well aware of the problem. A solution to solve it and return labs to former staffing levels is proving elusive. (Photo copyright: Forbes.)
Why the Shortfall?
In her Forbes article, Stone notes the following as factors behind the shortages:
Decline in training programs. “There are only [approximately] 240 medical laboratory technician and scientist training programs in the US, a 7% drop from 2000,” Stone wrote, adding that some states have no training programs at all. She notes that lab technicians must have a two-year associate degree while it takes an average of five years of post-secondary education to obtain a lab science degree.
Pay disparities. Citing data from the ASCP, Stone wrote that “medical lab professionals are paid 40%-60% less than nurses, physical therapists, or pharmacists.” Moreover, given the high cost of training, “many don’t feel the salary is worth the high investment,” she added.
Staff retention. In the ASCP’s 2018 job satisfaction survey, 85.3% of respondents reported burnout from their jobs, 36.5% cited problems with inadequate staffing, and nearly that many complained that workloads were too high.
Inconsistent licensing requirements. These requirements “are different from state to state,” Stone wrote. For example, the American Society for Clinical Laboratory Science (ASCLS) notes that 11 states plus Puerto Rico mandate licensure of laboratory personnel whereas others do not. Each of those states has specific licensing requirements, and while most offer reciprocity for other state licenses, “California [for example] does not recognize any certification or any other state license.”
In a 2018 report, “Addressing the Clinical Laboratory Workforce Shortage,” the ASCLS cited other factors contributing to the shortages, including retirement of aging personnel and increased demand for lab services.
Possible Solutions
Stone suggested the following remedies:
Improve working conditions. “We need to reduce the stress and workload of the lab professionals before we reach a greater crisis,” Stone wrote.
Standardize state certification. This will facilitate “mobility of staff and flexibility in responding to needs,” Stone suggested.
Improve education and training opportunities. The ASCLS has called for clinical lab science to be included in the Title VII health professions program, which provides funding for healthcare training. Rodney Rohde, PhD, a clinical laboratory science professor at Texas State University, “also suggests outreach to middle and high school STEM programs, to familiarize students early with career opportunities in the medical laboratory profession,” Stone wrote.
Recruit foreign workers. Stone suggested this as an interim solution, with programs to help them acclimate to practice standards in the US.
It will likely take multiple solutions like these to address the Great Resignation and bring the nation’s clinical laboratory staffing levels back to full. In the meantime, across the nation, a majority of clinical laboratories and anatomic pathology groups operate short-staffed and use overtime and temporary workers as a partial answer to their staffing requirements.
Outspoken Wecht wants readers to understand ‘the multifaceted challenges of the interface of law and medicine’
Pathologists will recognize the name of nationally-acclaimed forensic pathologist Cyril Wecht, MD, JD, who for more than a half-century has been at the center of many of the country’s highest-profile civil and criminal cases. Thus, Dark Daily readers will be intrigued to learn the so-called “godfather of forensic pathology” has published a memoir that takes readers behind the scenes of many of his most controversial forensic pathology cases.
In his recently published memoir (above), forensic pathologist Cyril Wecht, MD, JD, offers readers an inside look at some of his most controversial cases, as well as a defense of his own brushes with the legal system. Anatomic and clinical pathologists may be especially intrigued by Wecht’s description of how “he was acquitted on charges of personally profiting from his office as Allegheny County Coroner” during a federal public corruption charge that was dismissed in 2008, the book’s description states. (Photo copyright: Exposit Books.)
A ‘No-Holds-Barred’ Account
According to TribLIVE, the book—written by Wecht and award-winning writer/filmmaker Jeff Sewald—is a “no-holds-barred account” of Wecht’s personal and professional life. Among the more interesting tidbits are details regarding Wecht’s 1972 discovery that JFK autopsy materials and specimens had gone missing.
“They had been in the government’s possession, so nobody could have touched them, but now the metal container which has held John Kennedy’s brain in formalin was no longer on the list of contents. In addition, various photographs and microscopic tissue slides were also no longer listed. The President’s brain was missing!” wrote Wecht, who argued Lee Harvey Oswald did not act alone in killing JFK and may not have fired the shots that killed him.
In 2006, Wecht faced an 84-count federal public corruption trial, which resulted in him resigning as Alleghany, Pa. medical examiner, the Pittsburgh Post-Gazette reported. In his memoir, Wecht wrote extensively about his public corruption trial. TribLIVE noted Wecht “expresses particular disgust” over the accusation that he supplied Pittsburgh’s Carlow University with cadavers in exchange for use of their laboratory space for his own practice. His trial ended in a hung jury.
“The body-snatching issue was seized upon by the media and was the subject of some of the most horrible cartoons ever,” Wecht wrote. “What made them especially horrible was the fact that I believe anti-Semitism was at their core. They made me look wicked and shadowy, like a ‘Shylock’ who was willing to stoop as low as selling human corpses for a handful of shekels. It was sickening.”
Wecht became known nationally through media appearances and his many decades of work as a medical-legal consultant in civil and criminal cases. At the 2000 Forensic Science and the Law Conference, television host and political commentator Geraldo Rivera, JD, stated, “I’ve known Cyril Wecht for most of my 30-year broadcasting career, and my respect for him has only grown over the decades. His skills as an attorney, as a pathologist, as a medical examiner are legendary.
“Dr. Wecht has guided my audiences through our coverage of crimes ranging from the Kennedy assassination to the O.J. Simpson trial to the JonBenet Ramsey murder mystery,” Rivera added. “And whether or not my audiences knew it, they were getting an education in forensic science—and a lesson in how medical science is applied to this country’s criminal laws.”
An ‘Expert’ and an ‘Irritant’
Though also certified in anatomic pathology and clinical pathology, Wecht has spent his career as a forensic pathologist focused on determining the cause of death. He has performed approximately 17,000 autopsies and has supervised, reviewed, or been consulted on approximately 30,000 additional postmortem examinations, the Cyrilwecht.com website states.
Cyril Wecht, MD, JD (above), told the Pittsburgh Jewish Chronicle that he wrote this memoir so readers could understand the “… complexity and the multifaceted challenges of the interface of law and medicine, specifically in the realm of pathology, and how important it is for justice to be served, with the input from forensic science, and how the system can be subverted, perverted, suppressed, and manipulated.” (Photo copyright: Pittsburg Business Times.)
Pathologists who followed Wecht’s career may know of his reputation “as both an expert and an irritant,” noted the Pittsburg Post-Gazette. For his part, Wecht stated, “If I had been a bit more diplomatic and patient, and a little less antagonistic and controversial, I might have achieved more,” the newspaper reported.
Anyone interested in forensic pathology will likely enjoy reading the behind-the-scenes stories from Wecht’s more than six decades of work. But Wecht’s memoir should be particularly intriguing and informative for clinical and anatomic pathologists, as well as all medical laboratory scientists.
