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FDA Grants Marketing Authorization to Diagnostic Tests for Chlamydia and Gonorrhea with At-Home Sample Collection

Dec 18, 2023 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Resources, Laboratory Testing

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.

Simple 2 Home Collection Kits are available over the counter for anyone 18 or older. The kits employ Hologic’s Aptima collection devices, according to a company press release. A prepaid shipping label is also included to enable delivery to one of LetsGetChecked’s medical laboratories. The company performs the tests using the Hologic Aptima Combo 2 assay for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

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.

Jeff Shuren, MD, JD

“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.

—Stephen Beale

Related Information:

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with At-Home Sample Collection

LetsGetChecked Receives US Food and Drug Administration (FDA) De Novo Authorization for At-Home Chlamydia and Gonorrhea Testing System

FDA Grants Approval for First Time to a Home Test for Chlamydia and Gonorrhea

FDA Authorizes First Home Test for Chlamydia and Gonorrhea

You Can Now Test for Chlamydia and Gonorrhea with an At-Home Kit FDA Approves Home Test for Chlamydia and Gonorrhea

Clinical Laboratory Test for Alzheimer’s Disease Gets Ever Closer to Reality

Aug 23, 2019 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing

Scientists worldwide engaged in research to develop a biomarker for dementia are predicting success, though some say additional research will be needed

Could a blood test for Alzheimer’s disease soon be on clinical laboratory test menus nationwide? Perhaps so. A recent Associated Press (AP) article that was picked up by NBC News and other healthcare publications reported that experimental test results presented during the Alzheimer’s Association International Conference (AAIC) in July suggest the Holy Grail of dementia tests—one where the specimen can be collected in a doctor’s office during a routine screening exam—may be close at hand.

The AP story noted that “half a dozen research groups gave new results on various experimental tests, including one that seems 88% accurate at indicating Alzheimer’s risk.” And Richard Hodes, MD, Director of the National Institute on Aging, told AP, “In the past year, we’ve seen a dramatic acceleration in progress [on Alzheimer’s tests]. This has happened at a pace that is far faster than any of us would have expected.”

This could be a boon for medical laboratories seeking way to contribute more value to patient care. Especially among Alzheimer’s patients, who account for as many as 70% of all dementia cases.

Plasma Biomarker for Predicting Alzheimer’s

One of the experimental blood tests presented at the AAIC involved a 2018 study into “the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening,” the researchers stated an article they published in Nature.

Dark Daily reported on this study in “Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear; Could Eventually Give Clinical Laboratories a Diagnostic Tool,” June 4, 2018. The test “measures abnormal versions of the protein [amyloid beta] that forms the plaques in the brain that are the hallmark of Alzheimer’s,” the AP story reported.

AP also reported that Japanese scientists at the AAIC presented results of a validation test conducted on 201 people who had either Alzheimer’s, other types of dementia, or little or no symptoms. They found that the test “correctly identified 92% of people who had Alzheimer’s and correctly ruled out 85% who did not have it, for an overall accuracy of 88%.”

Akinori Nakamura, MD, PhD, of the National Center for Geriatrics and Gerontology in Obu, Japan, was a member of the research team and first author of the research paper. He told the AP that the test results “closely matched those from the top tests used now—three types of brain scans and a mental assessment exam.”

Eric McDade, DO (above), Associate Professor of Neurology at Washington University in St. Louis, told Neurology Today, “The results reported here provide a relatively high level of confidence given that this is a relatively well characterized population with an amyloid PET scan to provide confirmation of a significant level of amyloid plaque burden in the brain.” Could this level of physician confidence lead to a clinical laboratory test based on the plasma biomarker? (Photo copyright: Washington University.)

Koichi Tanaka is a Japanese engineer who won the Nobel prize winner for chemistry. He heads the Koichi Tanaka Research Lab at Shimadzu Corp. (OTCMKTS:SHMZF) in Kyoto, Japan, and was on the team that developed the Amyloid beta biomarker test that was presented at AAIC. He told Bloomberg, “Our finding overturned the common belief that it wouldn’t be possible to estimate amyloid accumulation in the brain from blood. We’re now being chased by others, and the competition is intensifying.”

But Tanaka cautions that the test needs further study before it is ready for clinical use, and that for now “it belongs in the hands of drug developers and research laboratories,” Bloomberg reported.

Other Studies into Developing an Alzheimer’s Biomarker

Alzheimer’s is usually diagnosed after symptoms appear, such as memory loss. To arrive at their diagnoses, doctors often rely on medical history, brain imaging (MRI, CT), PET, and measurement of amyloid in spinal fluid.  

An article published on Alzforum, a website and news service dedicated to the research and treatment for Alzheimer’s and other related disorders, noted a study by King’s College London researchers who, using mass spectrometry, “found a panel of biomarkers that predicted with almost 90% accuracy whether cognitively normal people had a positive amyloid scan.”

Nicholas Ashton, PhD, neuroscientist and Wallenberg Postdoctoral Fellow at University of Gothenburg in Sweden, and first author of the King’s College study, explained that “Amyloid-burden and neurofilament light polypeptide (NFL) peptides were important in predicting Alzheimer’s, but alone they weren’t as predictable as when we combined them with novel proteins related to amyloid PET.”

The researchers published their study earlier this year in Science Advances. “Using an unbiased mass spectrometry approach, we have found and replicated with high accuracy, specificity, and sensitivity a plasma protein classifier reflecting amyloid-beta burden in a cognitively unimpaired cohort,” the researchers wrote.

Meanwhile, researchers at Washington University School of Medicine St. Louis, along with the German Center for Neurodegenerative Diseases, a member of the Helmholtz Association, stated in a news release that a blood test they developed works by detecting leaks of NFL before the onset of symptoms. When the protein is found in cerebrospinal fluid, it could be a sign that Alzheimer’s may develop, as well as point to other neurodegenerative conditions such as multiple sclerosis, brain injury, or stroke, the researchers stated.  

“This is something that would be easy to incorporate into a screening test in a neurology clinic,” Brian Gordon, PhD, Assistant Professor of Radiology at Washington University’s Mallinckrodt Institute of Radiology, and an author of the study, stated in the news release.

These parallel studies into screening for Alzheimer’s by researchers worldwide are intriguing. The favorable results suggest that someday there may be a screen for Alzheimer’s using a clinical laboratory blood test.

With Alzheimer’s affecting nearly six million Americans of all ages, such an assay would enable clinical laboratories to help many people.

—Donna Marie Pocius

Related Information:

Scientists Close in On Blood Test for Alzheimer’s

Advances in the Global Search for Blood Markers for Alzheimer’s Disease and Other Dementias

A Blood Test Can Predict Dementia. Trouble Is, There’s No Cure

Plasma Biomarker for Amyloid Correlates with Alzheimer’s Progression, Study Finds

High Performance Plasma Amyloid-β Biomarkers for Alzheimer’s Disease

Panel Blood Markers Signals Amyloid in Brain

A Plasma Protein Classifier for Predicting Amyloid Burden for Preclinical Alzheimer’s Disease

Blood Test Detects Alzheimer’s Damage Before Symptoms; Test Also May Identify Neurodegeneration in Other Brain Diseases

Blood-Brain Barrier Breakdown is an Early Biomarker of Human Cognitive Dysfunction

Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear Could Eventually Give Clinical Laboratories A Diagnostic Tool

Harvard Researchers Find that 83% of Radiologists Fail to See Gorilla in the Midst—of a Lung Scan!

Jun 5, 2013 | Laboratory News, Laboratory Pathology

Pathologists and clinical laboratory managers should be aware of the possibility of ‘inattentional blindness’ as a potential cause for diagnostic and laboratory error

Pathologists and clinical laboratory professionals who regularly analyze images will be interested in the findings of a research study designed to assess how the phenomenon called “inattentional blindness” among radiologists could cause them to possibly miss things hiding in plain sight.

‘Inattentional Blindness’ Occurs Even Among Highly-trained Radiologists

In a recent study, psychological scientists from Harvard’s Brigham and Women’s Hospital found that 83% of radiologists didn’t notice an image of a gorilla embedded in a computed tomography (CT) lung scan. (more…)

Pathology Study Team Recommends Replacing Traditional Autopsies with Non-invasive, Imaging-based Alternative for the United Kingdom

Dec 14, 2012 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

Evolving imaging technology could begin to replace some traditional autopsy methodologies and encourage an increase in the number of autopsies performed

New imaging technology may give pathologists in the United Kingdom a new way to perform non-invasive autopsies. It is another example of how long-standing clinical practices can be transformed by the capabilities of newly developed technologies.

Leading experts within the field of post-mortem cross-sectional imaging in Britain have recommended that England’s National Health Service (NHS) introduce alternative techniques for performing non-invasive autopsies. A review of current procedures in the NHS system showed that alternative autopsy methodologies offer important advantages. In some circumstances, the non-invasive approach could replace traditional autopsy methods. (more…)

In Clinical Trials, Breath Test for Lung Cancer Shows Promise for Earlier Detection

May 16, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

Pathologists may do fewer lung biopsies should non-invasive breath testing technology make it into clinical practice

Here’s a medical laboratory test for diagnosing cancer that has the potential to score two runs with one swing of the bat. First, researchers have completed the first clinical trial of a non-invasive cancer test that utilizes a breath specimen.

Second, the subject of this clinical trial was lung cancer—a type of cancer that would benefit from a pathology test that can detect the disease much earlier. This would increase the survival rates for lung cancer, which currently has a five-year mortality rate of 90%.

As many pathologists and clinical laboratory managers know, it is possible to use breath specimens to diagnose a variety of diseases and health conditions. For almost 20 years, breath samples have been used to test for Helicobacter pylori, the bacteria which causes ulcers in the stomach.
(more…)

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