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

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....

Interest in Purchasing/Performing At-home Medical Tests Grows Among Older Adults, according to University of Michigan Poll

As clinical laboratory self-testing expands, sharing of test results with healthcare providers becomes even more essential to optimize health outcomes

Survey data collected by the University of Michigan’s Institute for Healthcare Policy and Innovation (IHPI) indicates that consumer interest in direct-to-consumer (DTC) medical self-testing is growing. In fact, DTC testing appears to be more popular ever, even among older adults who were asked how they feel about performing clinical laboratory self-testing and specimen collecting for certain illnesses.

With support from AARP and the Michigan Medicine Department of Communications, more than 2,000 older adults between the ages of 50 and 80 responded to the IHPI’s National Poll on Healthy Aging (NPHA) either online or by telephone.

According Michigan Medicine’s MHealth Lab, “82% of older adults say that in the future, they would be somewhat or very interested in taking a medical test at home.”

Dark Daily has written regularly about this trend and how leaders need a strategy to serve this class of consumer. That strategy could include collecting the self-test results from consumers and keeping a complete record of consumers’ clinical laboratory test results from inpatient, outpatient, and self-test settings.

Jeffrey Kullgren, MD

“As more companies bring these direct-to-consumer [medical] tests to market and buy ads promoting them, it’s important for healthcare providers and policymakers to understand what patients might be purchasing, what they’re doing with the results, and how that fits into the broader clinical and regulatory picture,” said research scientist Jeffrey Kullgren, MD (above), Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in a press release. Clinical laboratories may find opportunities to support patients’ self-testing in tandem with the physicians who treat them. (Photo copyright: University of Michigan.)

Importance of Sharing Clinical Laboratory Self-Test Results

Individuals responding to the poll were asked only about medical laboratory self-tests they had purchased themselves either online or at a retail store. Tests provided to respondents by a healthcare provider or given to them for free were not part of the survey.

The researchers discovered that 48% of respondents had purchased at least one variety of at-home health tests in the past. The types of tests bought included:

  • COVID-19 (32%),
  • DNA/genetic kits (17%),
  • Cancer tests, such as colon or prostate (6%),
  • Tests for infections other than COVID-19, such as urinary tract infections or HIV (4%), and
  • Other types of at-home tests, including those for allergies and food sensitivities (10%).

Approximately 82% of the respondents said they would be somewhat or very interested in taking at-home medical tests and nine out of 10 believed the test results should be shared with their doctors. But only 55% of respondents who had taken an at-home medical test and received positive results for infection other than COVID-19 had shared those results with their primary care physician.

However, 90% of respondents who had purchased a self-test for cancer screening did provide their doctors with the results.

“As we have seen in COVID-19, it’s important to share results from a home test with a provider so that it can be used to guide your care and be counted in official statistics,” said Jeffrey Kullgren, MD, Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in an IHPI press release. Kullgren, a primary care physician and healthcare researcher at Michigan Medicine and the VA Ann Arbor Healthcare System, directed the IHPI poll.

Not All Medical Self-Tests Are Regulated by the FDA

The most prominent reason for wanting to use at-home tests was convenience and 59% of those surveyed felt that the results could be trusted. 

The poll also found that 53% of older adults believe at-home medical tests are regulated by the federal government, which isn’t always the case. Many at-home medical tests are reviewed by the federal US Food and Drug Administration (FDA), but not all such tests receive full FDA review.

The FDA, however, offers an online, searchable database consumers can use to determine if a certain over-the-counter test is regulated by the FDA.  

“Home tests can be a convenient way for older adults to check if they have an illness, such as COVID-19” stated Indira Venkat, Senior Vice President, AARP Research in the press release. “But consumers should make sure they know whether the test they are taking is FDA-approved, and how their health or genetic information might be shared.”

Other interesting outcomes of the research include:

  • The purchasing of at-home COVID-19 tests was highest among those between the ages of 50 and 64 when compared to the 65 to 80 age group, but there were no age differences for other types of at-home tests.
  • Respondents who are married or have who more education and/or higher household incomes were more likely to have purchased at-home tests.
  • Blacks were less likely to buy at-home medical tests than Whites or Hispanics.
  • Interest for at-home tests was higher among women than men.
  • Advertising swayed 44% of purchasing respondents to buy a DNA test and 11% to buy a cancer screening test.

Are DTC Home Tests as Accurate as Clinical Laboratory Testing?

At-home medical self-testing and sample collection is becoming accepted and established with consumers and the medical community, which is drawing attention to the accuracy of these tests and how clinical laboratories are being affected by the trend.

In “Patient Safety Organization Releases Report Rating COVID-19 Home Tests for Ease of Use,” we covered the Emergency Care Research Institute’s investigation into certain COVID-19 rapid antigen tests to find out how easy—or not—they are to use and what that means for the accuracy of the tests’ results.

And in “‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories,” we reported how growth in this segment could lead to new diagnostic tests that could boost a medical laboratory’s bottom line or, conversely, reduce its revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.

The findings of this recent survey of older consumers is just the latest evidence that at-home self-testing for everything from COVID to cancer is here to stay. Clinical laboratories should be looking for ways to serve this patient population and the physicians who treat them.

JP Schlingman

Related Information:

Medical Tests at Home: Poll Shows High Interest, Uneven Use

The National Poll on Healthy Aging at Five Years

Medical Tests in the Comfort of Your Own Home: Poll Shows High Interest, Uneven Use by Older Adults

At-Home Medical Tests

Self-Testing at Home or Anywhere: For Doing Rapid COVID-19 Tests Anywhere

Patient Safety Organization Releases Report Rating COVID-19 Home Tests for Ease of Use

‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories

Oregon Health and Science University Announces Program to Provide Patients with Hospital-Level Care in the Comfort of Their Home

As the number of Hospital at Home programs increase, clinical laboratories will want to develop programs for collecting samples from patients where they live

Shortages of nurses and hospital staff, combined with pressure to lower the cost of care, are encouraging more institutions to implement hospital-in-the-home programs. One such project involves Oregon Health and Science University (OHSU), which last November began a Hospital at Home (HaH) program that enables certain patients to receive hospital-level care in the comfort of their own homes. Clinical laboratories servicing these programs will need to develop specimen collection and testing services in support of these patients.

The OHSU program can provide healthcare for eight patients simultaneously, and it has treated more than 100 patients at home since its inception. Although this number is only a small segment of OHSU’s 576 bed capacity, it does affect the overall healthcare provided by the hospital.

Under the program, basic services, such as the monitoring of vital signs—as well as some clinical laboratory work and routine imaging studies—are performed in the patient’s home. Individuals are transported to OHSU for more complex imaging or other procedures.

Matthias Merkel, MD, PhD

“Every patient we have in Hospital at Home is one who is not waiting in the emergency room or a hallway for a bed to become available in the hospital,” said Matthias Merkel, MD, PhD (above), Senior Associate Chief Medical Officer, Capacity Management and Patient Flow at OHSU, in a press release. In the same way clinical laboratories support telehealth programs, medical laboratories will need procedures for collecting specimens and testing patients participating in Hospital at Home programs as well. (Photo copyright: Oregon Health and Science University.)


Better Patient Experience, Increases Hospital Capacity

OHSU’s HaH program utilizes advances in technology to connect at-home patients with physicians and nurses around the clock via a smart tablet. In addition, participating patients receive real-time monitoring and at least two daily in-person visits from nurses and paramedics that have been contracted by OHSU.

“It’s a better experience for patients, plus it increases our system’s capacity to provide care for all the people who need it,” said Darren Malinoski, MD, Chief Clinical Transformation Officer and Professor of Surgery at OHSU in the press release. “It allows us to make good on our promise to take care of the state as best we can.”

The current eligibility criteria to participate in OHSU’s Hospital at Home program include:

  • Patient must be over the age of 18.
  • Patient’s primary residence must be within a 25-mile radius of the OHSU hospital.
  • Inpatient hospitalization is initially required.
  • Patient must have a diagnosis that can be managed remotely, such as COVID-19, pneumonia, cellulitis, congestive heart failure, urinary tract infections, or pyelonephritis.

Malinoski feels that OHSU’s HaH program is ready to expand. In fact, he is so confident in it he enrolled his own 83-year-old mother as one of its first patients. While undergoing treatment for lung cancer, a routine clinical checkup exposed evidence of toxicity in her blood. Typically, she would have been directly admitted to the hospital for monitoring, but instead she was entered into the HaH program.

“It was unbelievable,” stated Lesley Malinoski in the press release. “I had the feeling of being well taken care of. I was in my own home. I could cook, I could rest—anything I wanted and still have all this care.”

“They didn’t just come in and run out,” she continued. “I felt like a celebrity.”

COVID-19 Pandemic Drove Remote Healthcare Programs

HaH programs around the country were made possible through a federal waiver granted by the federal Centers for Medicare and Medicaid Services (CMS) in November 2020 in response to the COVID-19 pandemic.

According to the American Hospital Association (AHA), “this care delivery model has been shown to reduce costs, improve outcomes, and enhance the patient experience.”

Prior to the waiver, there were only about two dozen hospitals across the US that had HaH programs. However, as of May 20, 2022, 227 hospitals in 35 states had received a HaH waiver from CMS. This number represents nearly 4% of all hospitals in the country, according to Health Affairs.

Dark Daily has published many stories about Hospital at Home programs in the past. In “Hospital-in-the-Home Shows Promise for Reducing Acute Care Costs; Medical Laboratories Face Uncertainties Concerning Expanding Services to In-Home Environments in Support of Care Providers,” we described an example of an HaH model of clinical care implemented at Brigham and Women’s Faulkner Hospital in Boston where, despite initial reservations from staff, their testing of hospital-at-home care was well received.

In “Two US Studies Show Home-based Hospital Care Lowers Costs while Improving Outcomes and Patient Satisfaction,” we reported on a hospital-based home care program that involved 323 patients at Presbyterian Healthcare Services in Albuquerque, N.M. We surmised that significant growth in the number of patients treated in home-based hospital care programs would directly affect hospital-based clinical laboratories and pathology groups. Among other things, it would reduce the volume of inpatient testing while increasing the number of outpatient/outreach specimens.

And in “Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes,” Dark Daily saw that wider adoption of that country’s Hospital in the Home (HITH) model of patient care would directly affect pathologists and clinical laboratory managers who worked in Australia’s hospital laboratories. We reported that more HITH patients would increase the need to collect specimens in patient’s homes and transport them to a local clinical laboratory for testing, and that because they are central to the communities they serve, hospital-based medical laboratories would be well-positioned to provide this diagnostic testing.

OHSU’s overall experience with their Hospital at Home program demonstrates that such a model can be a highly successful and cost-effective method of providing patient care. It is probable that in the future, more medical institutions will create similar programs in an effort to effectively serve as many patients as possible while ensuring shorter hospital stays and rendering better healthcare outcomes. As this happens, it will give hospital-based medical laboratories an opportunity to deliver value in home-based patient care. 

JP Schlingman

Related Information:

Hospital at Home: Amid hospital Capacity Crisis, OHSU Offers an Alternative

Given Regulatory Uncertainty, Hospital-at-Home Models Are Losing Momentum

The Benefits of Treating Patients at Home Instead of in the Hospital

AHA: Extending the Acute Hospital Care at Home Program Beyond the End of the COVID-19 PHE

Hospital at Home Is Not Just for Hospitals

What We Learned from the Acute Hospital Care at Home Waiver—and What We Still Don’t Know

Hospital-in-the-Home Shows Promise for Reducing Acute Care Costs; Medical Laboratories Face Uncertainties Concerning Expanding Services to In-Home Environments in Support of Care Providers

Two US Studies Show Home-based Hospital Care Lowers Costs while Improving Outcomes and Patient Satisfaction

Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes

FDA Expands Approval of Gastric Emptying Breath Test for Gastroparesis to Include At-home Administration Under Virtual Supervision

It may not be a boom trend, but more non-invasive diagnostic tests are coming to market as clinical laboratory tests that use breath as the specimen

Here’s a development that reinforces two important trends in diagnostics: non-invasive clinical laboratory assays and patient-self testing. Recently, the FDA expanded the clearance of one diagnostic test to allow patients to collect their own breath specimen at home under the supervision of the test manufacturer’s telehealth team.

The C-Spirulina Gastric Emptying Breath Test (GEBT) breath test from Cairn Diagnostics initially received federal Food and Drug Administration (FDA) approval in 2015. At that time, the test was required to be administered “at a physician’s office, a laboratory collection center, or in a tertiary care setting,” according to a 2016 news release.

Recently, however, the FDA announced it has “expanded the approval of the company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include ‘at home’ administration under virtual supervision of Cairn Diagnostics.”

Self-administration of at-home tests by patients guided virtually by healthcare professionals is a major advancement in telehealth. But will this virtual-healthcare method be popular with both patients and their physicians?

Clinical Laboratory Diagnostics and Telehealth

Spurring a far greater acceptance of telehealth among patients and healthcare providers is one of the many ways the COVID-19 pandemic has impacted healthcare.

“Telehealth, particularly during the COVID-19 pandemic, has emerged as a preferred option for healthcare providers,” noted Kerry Bush, President and COO of Cairn Diagnostics, in a 2021 news release

Cairn’s GEBT detects gastroparesis, a disease which, according to the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), affects 50 people in every 100,000. According to the CDC, it is also sometimes a complication of diabetes. Symptoms include nausea, heartburn, bloating, a feeling of fullness long after eating a meal, vomiting, belching, and pain in the upper abdomen, the NIDDK notes.

In people with gastroparesis—sometimes called “delayed gastric emptying”—muscles that normally move food from the stomach to the small intestine do not work as they should, and the food remains in the stomach for too long. The traditional diagnostic tool used to diagnose gastroparesis is scintigraphy. The patient consumes a meal that has radioactive material mixed in and the digestion process is observed using a nuclear medicine camera as the material is eliminated through the bowels.

Cairn Diagnostics’ C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics’ C-Spirulina Gastric Emptying Breath Test (above) recently received an expansion to its initial 2015 FDA approval that enables patients to self-administer the test at-home while being virtually guided by the company’s telehealth team. GEBTs are interpreted by CLIA-certified clinical laboratories and the results sent to patients’ doctors within 24-48 hours after testing. (Photo copyright: Cairn Diagnostics.)

Virtual Telehealth GEBT versus Scintigraphy

The telehealth process for Cairn Diagnostic’s Gastric Emptying Breath Test (GEBT) differs significantly from traditional scintigraphy testing. Once a physician prescribes the test, Cairn’s telehealth team contacts the patient to describe the virtual process. The team then ships the at-home test kit to the patient. To complete the testing, Cairn provides the patient with a web-based link to a secure audio/video platform.

During administration of the GEBT, a Cairn technician coaches the patient and supervises via video. Once the test is complete, the patient returns the breath samples to the CLIA-certified clinical laboratory by overnight courier. The test results are sent to the prescribing physician within 24-48 hours after the lab receives the samples.

Discovering New Uses for Breath as a Specimen for Clinical Laboratory Testing

For obvious reasons, patients prefer diagnostics that use specimens obtained noninvasively. GEBT is the latest in a growing list of diagnostic tests that use breath as a specimen.

For example, at Johns Hopkins clinicians employ breath testing to diagnose several conditions, including:

Each of these tests involves the patient consuming a particular substance, technicians capturing breath samples at certain intervals, and clinical laboratory personnel analyzing the samples to look for indicators of disease or intolerance.

New Types of Breath Tests

Breath samples are commonly used to diagnose gastrointestinal issues, but researchers also are seeking methods of using them to diagnose and monitor respiratory conditions as well.

In a recent study published in Nature Nanotechnology, scientists explored how breath can be used to monitor respiratory disease, noting that although breath contains numerous volatile metabolites, it is rarely used clinically because biomarkers have not been identified.

“Here we engineered breath biomarkers for respiratory disease by local delivery of protease-sensing nanoparticles to the lungs. The nanosensors shed volatile reporters upon cleavage by neutrophil elastase, an inflammation-associated protease with elevated activity in lung diseases such as bacterial infection and alpha-1 antitrypsin deficiency,” the researchers wrote.

Indeed, the search for new ways to use breath as a biological sample is being pursued by numerous groups and organizations. Owlstone Medical in the UK, for example, is developing breathalyzer tests for the detection of cancer as well as inflammatory and infectious disease.

“Exhaled breath is more than just air,” notes the company’s website. “It contains over 1,000 volatile organic compounds (VOCs) as well as microscopic aerosol particles, also known as respiratory droplets, originating from the lungs and airways.”

Analyzing breath allows for the:

  • investigation of biomarkers of disease,
  • patient stratification by phenotype,
  • detection and monitoring treatment response, and
  • measurement of exposure to harmful substances.

In fact, so many studies on using breath as a specimen have been conducted that in “Breath Biomarkers in Asthma: We’re Getting Answers, But What Are the Important Questions?” researchers Peter J. Sterk, PhD, Professor of Pulmonology at Amsterdam University Medical Centers, and immunity and respiratory medicine specialist Stephen J. Fowler, MD, FRCP, Professor of Respiratory Medicine at the University of Manchester in the UK suggested that systematic reviews are now feasible. They published their article in the European Respiratory Journal.

“Whilst we are still in this discovery stage it is time to refine our study designs so that we can make progress towards tailored clinical application,” they wrote. “Breathomics is perhaps at the ‘end of the beginning’ for asthma at least; it has a ‘sexy’ name, some promising and consistent findings, and the key questions are at least being recognized.”

Better for Patients, Clinicians, and Clinical Laboratories

Virtual telehealth tests, ordered by physicians, administered at home, and interpreted in CLIA-certified clinical laboratories, is a trend pathologists may want to watch carefully, along with the development of other tests that use human breath as the specimen. 

Less invasive, more personalized diagnostic tools that can be administered at home are better for patients. When those tools also provide detailed information, clinicians can make better decisions regarding care. Clinical laboratories that approach the use of at-home tests creatively, and which can accurately and quickly process these new types of tests, may have a market advantage and an opportunity to expand and grow.

Dava Stewart

Related Information:

Cairn Diagnostics Approved for At-Home Admin of Breath Test

Cairn Diagnostics Delivers Virtual Administration of Its Novel 13C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics Launches FDA-Approved Spirulina Gastric Emptying Breath Test for Gastroparesis

NIDDK: Definition and Facts for Gastroparesis

CDC: Diabetes and Digestion

Nuclear Medicine Gastric Emptying

Johns Hopkins: Gastroenterology and Hepatology

Nature: Engineering Synthetic Breath Biomarkers for Respiratory Disease

A Breathalyzer for Disease

Breath Biopsy—Biomarkers on Exhaled Breath

Breath Biomarkers in Asthma: We’re Getting Answers, But What Are the Important Questions?

Popular Science Review Finds Seven At-Home COVID-19 Antigen Tests ‘Easy to Use’ and ‘An Important Tool to Slow Spread of the Coronavirus’

    In a letter, Congress urged the HHS Secretary to conduct “vigorous oversight and enforces full compliance with the final rule”     Analysis of more than 3,100 hospital websites by The Wall Street Journal (WSJ) has found “hundreds” containing embedded code that prevents search engines from displaying the hospitals’ prices. This is contrary to the Hospital Price Transparency Final Rule (84 FR 65524), passed in November 2019, which requires hospitals to “establish, update,...