News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel
Sign In

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

FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

Apr 28, 2021 | Clinical Laboratory/Pathology Automation, Analyzers, Testing Systems, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, News From Dark Daily

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).

In a press release, the FDA announced it was “granting a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the binx health io CT/NG assay [binx io],” and that “it is allowing the use of the binx health io CT/NG assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities, and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.”

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.

binx-health-io-platform
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.”

Tim-Stenzel-MD-PhD-FDA
“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.

—Andrea Downing Peck

Related Information:

FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near Patient-Care Settings

Binx Health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

Binx Health Receives FDA 510(k) Clearance for Rapid Point of Care Platform for Women’s Health

POC Test for Chlamydia, Gonorrhea as Good as Lab-Based Assays

Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea

Rapid HIV Tests Suitable for Use in Non-Clinical Settings (CLIA Waived)

British Researchers Working on a Way to Use Cell Phones to Perform Pathology Tests for STDs

Nov 22, 2010 | Laboratory News, Laboratory Pathology

Clinical laboratory-on-a-chip would cost under £1 and allow young people to test themselves for sexually-transmitted diseases



Some wags call a new diagnostic testing concept the “pee in the cell phone” pathology lab test. The humor is directed at cell phone-based medical laboratory tests under development in the hopes that this confidential and private diagnostic test method will encourage more young people to undergo testing for sexually-transmitted diseases (STDs).

Newspapers in the United Kingdom are reporting on a research project—funded in part by the government—to develop STD tests that can be run on a USB-size chip that is inserted into a smart phone or a personal computer.

This project is a response to the significant rise in sexually transmitted infections (STIs) among young people. In the United Kingdom, the rate of new infections for herpes, chlamydia and gonorrhea are rising to record levels.

Clinical Laboratory Test on a Cell Phone or Personal Computer

(more…)

;