Best of all, the researchers say the test could provide an inexpensive means of early diagnosis. This assay could also be used to monitor how well patients respond to cancer therapy, according to a news release.
The protein had previously been identified as a promising biomarker and is readily detectable in tumor tissue, they wrote. However, it is found in extremely low concentrations in blood plasma and is “well below detection limits of conventional clinical laboratory methods,” they noted.
To overcome that obstacle, they employed an ultra-sensitive immunoassay known as a Simoa (Single-Molecule Array), an immunoassay platform for measuring fluid biomarkers.
“We were shocked by how well this test worked in detecting the biomarker’s expression across cancer types,” said lead study author gastroenterologist Martin Taylor, MD, PhD, Instructor in Pathology, Massachusetts General Hospital and Harvard Medical School, in the press release. “It’s created more questions for us to explore and sparked interest among collaborators across many institutions.”
“We’ve known since the 1980s that transposable elements were active in some cancers, and nearly 10 years ago we reported that ORF1p was a pervasive cancer biomarker, but, until now, we haven’t had the ability to detect it in blood tests,” said pathologist and study co-author Kathleen Burns, MD, PhD (above), Chair of the Department of Pathology at Dana-Farber Cancer Institute and a Professor of Pathology at Harvard Medical School, in a press release. “Having a technology capable of detecting ORF1p in blood opens so many possibilities for clinical applications.” Clinical laboratories may soon have a new blood test to detect multiple types of cancer. (Photo copyright: Dana-Farber Cancer Institute.)
Simoa’s Advantages
In their press release, the researchers described ORF1p as “a hallmark of many cancers, particularly p53-deficient epithelial cancers,” a category that includes lung, breast, prostate, uterine, pancreatic, and head and neck cancers in addition to the cancers noted above.
“Pervasive expression of ORF1p in carcinomas, and the lack of expression in normal tissues, makes ORF1p unlike other protein biomarkers which have normal expression levels,” Taylor said in the press release. “This unique biology makes it highly specific.”
Simoa was developed at the laboratory of study co-author David R. Walt, PhD, the Hansjörg Wyss Professor of Bioinspired Engineering at Harvard Medical School, and Professor of Pathology at Harvard Medical School and Brigham and Women’s Hospital.
The Simoa technology “enables 100- to 1,000-fold improvements in sensitivity over conventional enzyme-linked immunosorbent assay (ELISA) techniques, thus opening the window to measuring proteins at concentrations that have never been detected before in various biological fluids such as plasma or saliva,” according to the Walt Lab website.
Simoa assays take less than two hours to run and require less than $3 in consumables. They are “simple to perform, scalable, and have clinical-grade coefficients of variation,” the researchers wrote.
Study Results
Using the first generation of the ORF1p Simoa assay, the researchers tested blood samples of patients with a variety of cancers along with 406 individuals, regarded as healthy, who served as controls. The test proved to be most effective among patients with colorectal and ovarian cancer, finding detectable levels of ORF1p in 58% of former and 71% of the latter. Detectable levels were found in patients with advanced-stage as well as early-stage disease, the researchers wrote in Cancer Discovery.
Among the 406 healthy controls, the test found detectable levels of ORF1p in only five. However, the control with the highest detectable levels, regarded as healthy when donating blood, “was six months later found to have prostate cancer and 19 months later found to have lymphoma,” the researchers wrote.
They later reengineered the Simoa assay to increase its sensitivity, resulting in improved detection of the protein in blood samples from patients with colorectal, gastroesophageal, ovarian, uterine, and breast cancers.
The researchers also employed the test on samples from 19 patients with gastroesophageal cancer to gauge its utility for monitoring therapeutic response. Although this was a small sample, they found that among 13 patients who had responded to therapy, “circulating ORF1p dropped to undetectable levels at follow-up sampling.”
“More Work to Be Done”
The Simoa assay has limitations, the researchers acknowledged. It doesn’t identify the location of cancers, and it “isn’t successful in identifying all cancers and their subtypes,” the press release stated, adding that the test will likely be used in conjunction with other early-detection approaches. The researchers also said they want to gauge the test’s accuracy in larger cohorts.
“The test is very specific, but it doesn’t tell us enough information to be used in a vacuum,” Walt said in the news release. “It’s exciting to see the early success of this ultrasensitive assessment tool, but there is more work to be done.”
More studies will be needed to valid these findings. That this promising new multi-cancer immunoassay is based on a clinical laboratory blood sample means its less invasive and less painful for patients. It’s a good example of an assay that takes a proteomic approach looking for protein cancer biomarkers rather than the genetic approach looking for molecular DNA/RNA biomarkers of cancer.
Theranos founder and former CEO continues down the path she began by defrauding her investors and lying to clinical laboratory leaders about her technology’s capabilities
As a result of the ban, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector,” ARS Technica reported.
So, Holmes, who is 39-years old, is basically banned for life. This is in addition to her 11-year prison sentence which was paired with $452,047,200 in restitution.
“The exclusion was announced by Inspector General Christi Grimm of the Department of Health and Human Services’ Office of Inspector General,” ARS Technica noted, adding that HHS-OIG also “excluded former Theranos President Ramesh “Sunny” Balwani from federal health programs for 90 years.” This is on top of the almost 13-year-long prison sentence he is serving for fraud.
“The Health and Human Services Department can exclude anyone convicted of certain felonies from Medicare, Medicaid, and Pentagon health programs,” STAT reported.
“Accurate and dependable diagnostic testing technology is imperative to our public health infrastructure,” said Inspector General Christi Grimm (above) in an HHS-OIG statement. “As technology evolves, so do our efforts to safeguard the health and safety of patients, and HHS-OIG will continue to use its exclusion authority to protect the public from bad actors.” Observant clinical laboratory leaders will recognize this as yet another episode in the Elizabeth Holmes/Theranos fraud saga they’ve been following for years. (Photo copyright: HHS-OIG.)
Why the Ban?
“The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) cited Holmes’ 2022 conviction for fraud and conspiracy to commit wire fraud as the reason for her ban,” The Hill reported.
“False statements related to the reliability of these medical products can endanger the health of patients and sow distrust in our healthcare system,” Grimm stated in the HHS-OIG statement, which noted, “The statutory minimum for an exclusion based on convictions like Holmes’ is five years.
“When certain aggravating factors are present, a longer period of exclusion is justified,” the statement continued. “The length of Holmes’ exclusion is based on the application of several aggravating factors, including the length of time the acts were committed, incarceration, and the amount of restitution ordered to be paid.”
Rise and Fall of Elizabeth Holmes
Readers of Dark Daily’s e-briefs covering the Holmes/Theranos fraud saga will recall details on Holmes’ journey from mega success to her current state of incarceration for defrauding her investors.
In November 2022, she was handed an 11-year prison sentence for not disclosing that Theranos’ innovative blood testing technology, Edison, was producing flawed and false results. Theranos had “raised hundreds of millions of dollars, named prominent former US officials to its board, and explored a partnership with the US military to use its tests on the battlefield,” STAT reported.
To get Holmes physically into prison was a journey unto itself. At one point, evidence showed her as a potential flight risk. “In the same court filings, prosecutors said Holmes and her partner, William Evans, bought one-way tickets to Mexico in December 2021, a fact confirmed by her lawyers,” Dark Daily’s sister publication The Dark Report revealed in “Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director.”
Drama around her move into prison continued. “The former CEO’s attorneys are making last-minute legal moves to delay her prison sentence while she appeals her guilty verdict,” Dark Daily reported.
At the same time, Holmes appeared to be on a mission to revamp her public image.
In the Times piece, Holmes talked about her plans to continue to pursue a life in healthcare. “In the story, Holmes contended that she still thinks about contributing to the clinical laboratory field. Holmes told The Times that she still works on healthcare-related inventions and will continue to do so if she reports to prison,” The Dark Report covered in “Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare.”
In the meantime, her legal fees continued to mount beyond her ability to pay. “Holmes’ prior cadre of lawyers quit after she could not compensate them, The Times reported,” The Dark Report noted. “One pre-sentencing report by the government put her legal fees at more than $30 million,” according to The New York Times.
Apparently, this closes the latest chapter in the never-ending saga of Elizabeth Holmes’ fall from grace and ultimate conviction for defrauding her investors and lying to healthcare executives, pathologists, and clinical laboratory leaders.
According to an EADV press release, the AI software demonstrated a “100% (59/59 cases identified) sensitivity for detecting melanoma—the most serious form of skin cancer.” The AI software also “correctly detected 99.5% (189/190) of all skin cancers and 92.5% (541/585) of pre-cancerous lesions.”
“Of the basal cell carcinoma cases, a single case was missed out of 190, which was later identified at a second read by a dermatologist ‘safety net.’ This further demonstrates the need to have appropriate clinical oversight of the AI,” the press release noted.
AI is being utilized more frequently within the healthcare industry to diagnose and treat a plethora of illnesses. This recent study performed by scientists in the United Kingdom demonstrates that new AI models can be used to accurately diagnose some skin cancers, but that “AI should not be used as a standalone detection tool without the support of a consultant dermatologist,” the press release noted.
“The role of AI in dermatology and the most appropriate pathway are debated,” said Kashini Andrew, MBBS, MSc (above), Specialist Registrar at University Hospitals Birmingham NHS Foundation Trust. “Further research with appropriate clinical oversight may allow the deployment of AI as a triage tool. However, any pathway must demonstrate cost-effectiveness, and AI is currently not a stand-alone tool in dermatology. Our data shows the great promise of AI in future provision of healthcare.” Clinical laboratories and dermatopathologists in the United States will want to watch the further development of this AI application. (Photo copyright: LinkedIn.)
How the NHS Scientists Conducted Their Study
Researchers tested their algorithm for almost three years to determine its ability to detect cancerous and pre-cancerous growths. A group of dermatologists and medical photographers entered patient information into their algorithm and trained it how to detect abnormalities. The collected data came from 22,356 patients with suspected skin cancers and included photos of known cancers.
The scientists then repeatedly recalibrated the software to ensure it could distinguish between non-cancerous lesions and potential cancers or malignancies. Dermatologists then reviewed the final data from the algorithm and compared it to diagnoses from health professionals.
“This study has demonstrated how AI is rapidly improving and learning, with the high accuracy directly attributable to improvements in AI training techniques and the quality of data used to train the AI,” said Kashini Andrew, MBBS, MSc, Specialist Registrar at University Hospitals Birmingham NHS Foundation Trust, and co-author of the study, in EADV press release.
Freeing Up Physician Time
The EADV Congress where the NHS researchers presented their findings took place in October in Berlin. The first model of their AI software was tested in 2021 and that version was able to detect:
85.9% (195 out of 227) of melanoma cases,
83.8% (903 out of 1078) of all skin cancers, and
54.1% (496 out of 917) of pre-cancerous lesions.
After fine-tuning, the latest version of the algorithm was even more promising, with results that included the detection of:
100% (59 out of 59) cases of melanoma,
99.5% (189 out of 190) of all skin cancers, and
92.5% (541 out of 585) pre-cancerous lesions.
“The latest version of the software has saved over 1,000 face-to-face consultations in the secondary care setting between April 2022 and January 2023, freeing up more time for patients that need urgent attention,” Andrew said in the press release.
Still, the researchers admit that AI should not be used as the only detection method for skin cancers.
“We would like to stress that AI should not be used as a standalone tool in skin cancer detection and that AI is not a substitute for consultant dermatologists,” stated Irshad Zaki, B Med Sci (Hons), Consultant Dermatologist at University Hospitals Birmingham NHS Foundation Trust and one of the authors of the study, in the press release.
“The role of AI in dermatology and the most appropriate pathway are debated. Further research with appropriate clinical oversight may allow the deployment of AI as a triage tool,” said Andrew in the press release. “However, any pathway must demonstrate cost-effectiveness, and AI is currently not a stand-alone tool in dermatology. Our data shows the great promise of AI in future provision of healthcare.”
Two People in the US Die of Skin Cancer Every Hour
According to the Skin Cancer Foundation, skin cancer is the most common cancer in the United States as well as the rest of the world. More people in the US are diagnosed with skin cancer every year than all other cancers combined.
When detected early, the five-year survival rate for melanoma is 99%, but more than two people in the US die of skin cancer every hour. At least one in five Americans will develop skin cancer by the age of 70 and more than 9,500 people are diagnosed with the disease every day in the US.
The annual cost of treating skin cancers in the United States is estimated at $8.1 billion annually, with approximately $3.3 billion of that amount being for melanoma and the remaining $4.8 billion for non-melanoma skin cancers.
More research is needed before University Hospitals Birmingham’s new AI model can be used clinically in the diagnoses of skin cancers. However, its level of accuracy is unprecedented in AI diagnostics. This is a noteworthy step forward in the field of AI for diagnostic purposes that can be used by clinical laboratories and dermatopathologists.
Clinical laboratories and pathology groups should be on the alert to this new digital threat; telehealth sessions and video conferencing calls particularly vulnerable to acoustic AI attacks
Banks may be the first to get hit by a new form of hacking because of all the money they hold in deposit accounts, but experts say healthcare providers—including medical laboratories—are comparably lucrative targets because of the value of patient data. The point of this hacking spear is artificial intelligence (AI) with increased capabilities to penetrate digital defenses.
AI is developing rapidly. Are healthcare organizations keeping up? The hackers sure are. An article from GoBankingRates titled, “How Hackers Are Using AI to Steal Your Bank Account Password,” reveals startling new AI capabilities that could enable bad actors to compromise information technology (IT) security and steal from customers’ accounts.
Though the article covers how the AI could conduct cyberattacks on bank information, similar techniques can be employed to gain access to patients’ protected health information (PHI) and clinical laboratory databases as well, putting all healthcare consumers at risk.
The new AI cyberattack employs an acoustic Side Channel Attack (SCA). An SCA is an attack enabled by leakage of information from a physical computer system. The “acoustic” SCA listens to keystrokes through a computer’s microphone to guess a password with 95% accuracy.
“With recent developments in deep learning, the ubiquity of microphones and the rise in online services via personal devices, acoustic side channel attacks present a greater threat to keyboards than ever,” wrote UK study authors Joshua Harrison, MEng, Durham University; Ehsan Toreini, University of Surrey; and Maryam Mehrnezhad, PhD, University of London.
Hackers could be recording keystrokes during video conferencing calls as well, where an accuracy of 93% is achievable, the authors added.
This nefarious technological advance could spell trouble for healthcare security. Using acoustic SCA attacks, busy healthcare facilities, clinical laboratories, and telehealth appointments could all be potentially compromised.
“The ubiquity of keyboard acoustic emanations makes them not only a readily available attack vector, but also prompts victims to underestimate (and therefore not try to hide) their output,” wrote Joshua Harrison, MEng (above), and his team in their IEEE Xplore paper. “For example, when typing a password, people will regularly hide their screen but will do little to obfuscate their keyboard’s sound.” Since computer keyboards and microphones in healthcare settings like hospitals and clinical laboratories are completely ubiquitous, the risk that this AI technology will be used to invade and steal patients’ protected health information is high. (Photo copyright: CNBC.)
Why Do Hackers Target Healthcare?
Ransomware attacks in healthcare are costly and dangerous. According to InstaMed, a healthcare payments and billing company owned by J.P. Morgan, healthcare data breaches increased to 29.5% in 2021 costing over $9 million. And beyond the financial implications, these attacks put sensitive patient data at risk.
Healthcare can be seen as one of the most desirable markets for hackers seeking sensitive information. As InstaMed points out, credit card hacks are usually quickly figured out and stopped. However, “medical records can contain multiple pieces of personally identifiable information. Additionally, breaches that expose this type of data typically take longer to uncover and are harder for an organization to determine in magnitude.”
With AI advancing at such a high rate, healthcare organizations may be unable to adapt older network systems quickly—leaving them vulnerable.
“Legacy devices have been an issue for a while now,” Alexandra Murdoch, medical data analyst at GlobalData PLC, told Medical Device Network, “Usually big medical devices, such as imaging equipment or MRI machines are really expensive and so hospitals do not replace them often. So as a result, we have in the network these old devices that can’t really be updated, and because they can’t be updated, they can’t be protected.”
But telehealth, according to the UK researchers, may also be one way hackers get past safeguards and into critical hospital systems.
“When trained on keystrokes recorded using the video-conferencing software Zoom, an accuracy of 93% was achieved, a new best for the medium. Our results prove the practicality of these side channel attacks via off-the-shelf equipment and algorithms,” the UK researchers wrote in IEEE Xplore.
“[AI] has worrying implications for the medical industry, as more and more appointments go virtual, the implications of deepfakes is a bit concerning if you only interact with a doctor over a Teams or a Zoom call,” David Higgins, Senior Director at information security company CyberArk, told Medical Device Network.
Higgins elaborated on why healthcare is a highly targeted industry for hackers.
“For a credit card record, you are looking at a cost of one to two dollars, but for a medical record, you are talking much more information because the gain for the purposes of social engineering becomes very lucrative. It’s so much easier to launch a ransomware attack, you don’t even need to be a coder, you can just buy ransomware off of the dark web and use it.”
Steps Healthcare Organizations Should Take to Prevent Cyberattacks
Hackers will do whatever they can to get their hands on medical records because stealing them is so lucrative. And this may only be the beginning, Higgins noted.
“I don’t think we are going to see a slowdown in attacks. What we are starting to see is that techniques to make that initial intrusion are becoming more sophisticated and more targeted,” he told Medical Device Network. “Now with things like AI coming into the mix, it’s going to become much harder for the day-to-day individual to spot a malicious email. Generative AI is going to fuel more of that ransomware and sadly it’s going to make it easier for more people to get past that first intrusion stage.”
To combat these attacks patient data needs to be encrypted, devices updated, and medical staff well-trained to spot cyberattacks before they get out of hand. These SCA attacks on bank accounts could be easily transferable to attacks on healthcare organizations’ patient records.
Clinical laboratories, anatomic pathology groups, and other healthcare facilities would be wise to invest in cybersecurity, training for workers, and updated technology. The hackers are going to stay on top of the technology, healthcare leaders need to be one step ahead of them.
One goal of these new functions is to streamline physician workflows. However, these new EHRs may interface differently with clinical laboratory information systems
Artificial intelligence (AI) developers are making great contributions in clinical laboratory, pathology, radiology, and other areas of healthcare. Now, Electronic Health Record (EHR) developers are looking into ways to incorporate a new type of AI—called “Generative AI”—into their EHR products to assist physicians with time-consuming and repetitive administrative tasks and help them focus on patient-centered care.
Generative AI uses complex algorithms and statistical models to learn patterns from collected data. It then generates new content, including text, images, and audio/video information.
According to the federal Government Accountability Office (GAO), generative AI “has potential applications across a wide range of fields, including education, government, medicine, and law” and that “a research hospital is piloting a generative AI program to create responses to patient questions and reduce the administrative workload of healthcare providers.”
Reducing the workload on doctors and other medical personnel is a key goal of the EHR developers.
Generative AI uses deep learning neural networks modeled after the human brain comprised of layers of connected nodes that process data. It employs two neural networks: a generator [generative network] which creates new content, and a discriminator [discriminative network] which evaluates the quality of that content.
The collected information is entered into the network where each individual node processes the data and passes it on to the next layer. The last layer in the process produces the final output.
Many EHR companies are working toward adding generative AI into their platforms, including:
As our sister publication The Dark Report points out in its December 26 “Top 10 Biggest Lab Stories for 2023,” almost every product or service presented to a clinical laboratory or pathology group will soon include an AI-powered solution.
“We believe that generative AI has the potential of being a personal assistant for every doctor, and that’s what we’re working on,” Girish Navani (above), co-founder and CEO of eClinicalWorks, told EHRIntelligence. “It could save hours. You capture the essence of the entire conversation without touching a keyboard. It is transformational in how it works and how well it presents the information back to the provider.” Clinical laboratory information systems may also benefit from connecting with generative AI-based EHRs. (Photo copyright: eClinicalWorks.)
Generative AI Can Help with Physician Burnout
One of the beneficial features of generative AI is that it has the ability to “listen” to a doctor’s conversation with a patient while recording it and then produce clinical notes. The physician can then review, edit, and approve those notes to enter into the patient’s EHR record, thus streamlining administrative workflows.
“The clinician or support team essentially has to take all of the data points that they’ve got in their head and turn that into a narrative human response,” Phil Lindemann, Vice President of Data and Analytics at Epic, told EHRIntelligence. “Generative AI can draft a response that the clinician can then review, make changes as necessary, and then send to the patient.”
By streamlining and reducing workloads, EHRs that incorporate generative AI may help reduce physician burnout, which has been increasing since the COVID-19 pandemic.
“Language models have a huge potential in impacting almost every workflow,” Girish Navani, co-founder and CEO of eClinicalWorks, told EHRIntelligence. “Whether it’s reading information and summarizing it or creating the right type of contextual response, language models can help reduce cognitive load.”
Generative AI can also translate information into many different languages.
“Health systems spend a lot of time trying to make patient education and different things available in certain languages, but they’ll never have every language possible,” Lindemann said. “This technology can take human language, translate it at any reading level in any language, and have it understandable.”
MEDITECH is working on a generative AI project to simplify clinical documentation with an emphasis on hospital discharge summaries that can be very laborious and time-consuming for clinicians.
“Providers are asked to go in and review previous notes and results and try to bring that all together,” Helen Waters, Executive Vice President and COO of MEDITECH, told EHRIntelligence. “Generative AI can help auto-populate the discharge note by bringing in the discrete information that would be most relevant to substantiate that narrative and enable time savings for those clinicians.”
Many Applications for Generative AI in Healthcare
According to technology consulting and solutions firm XenonStack, generative AI has many potential applications in healthcare including:
The technology is currently in its early stages and does present challenges, such as lack of interpretability, the need for large datasets and more transparency, and ethical concerns, all of which will need to be addressed.
“We see it as a translation tool,” Lindemann told EHRIntelligence. “It’s not a panacea, but there’s going to be really valuable use cases, and the sooner the community can agree on that, the more useful the technology’s going to be.”
Since generative AI can be used to automate manual work processes, clinical laboratories and anatomic pathology groups should be alert to opportunities to interface their LISs with referring physicians’ EHRs. Such interfaces may enable the use of the generative AI functions to automate manual processes in both the doctors’ offices and the labs.
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.
