News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Monkeypox Clinical Laboratory Testing Capacity in US Is Strong according to CDC Director. But Is It really?

Testing capacity has been boosted by inclusion of commercial laboratory companies and the fact that the virus spreads less easily than SARS-CoV-2

At the start of the SARS-CoV-2 pandemic, clinical laboratories were unprepared for unprecedented testing volumes. Fast forward to today, and the monkeypox outbreak has some clinical laboratory managers and pathologists wondering if they might again be faced with a surge in demand for monkeypox testing.

The good news is that so far the supply of tests appears adequate, especially compared to the early days of COVID-19.

Back in spring 2020, many clinical laboratories simply could not keep up with the overwhelming demand for COVID-19 tests. In “In New Hampshire, Cooperation Was Key to Handling Clinical Laboratory Testing Challenges Posed by the COVID-19 Outbreak,” Dark Daily reported how the state’s public health laboratory was not prepared for the surge in test requests.

By comparison, monkeypox testing capacity is currently in a far better position, said Rochelle Walensky, MD, Director of the federal Centers for Disease Control and Prevention (CDC), during a hearing before the US Senate’s Health, Education, Labor, and Pension (HELP) Committee on Sept. 14.

“We’ve always had more capacity than we have had tests coming in,” Walensky noted. “To date, we’ve used about 14% to 20% of our capacity.”

Rochelle Walensky, MD

During a hearing before the Senate Health, Education, Labor, and Pensions Committee on the current state of monkeypox testing capacity in the US, Rochelle Walensky, MD (above), Director at the CDC said, “We worked through commercial labs to expand testing across the country and simultaneously [offered] outreach and education to providers, clinicians, patients, and public health.” At the moment, access to clinical laboratory testing for monkeypox appears stable, but that could change as demand grows. (Photo copyright: CDC.)

Capacity Sits at 80,000 Tests Per Week in the US

When the monkeypox outbreak began, US medical laboratories could run 6,000 tests per week. At the time, this was more than sufficient, according to a White House press briefing.

However, since then, demand for testing has increased across the country to 80,000 tests per week. As part of that effort, the CDC partnered with five commercial laboratories to expand access to testing, according to the federal Department of Health and Human Services (HHS), Dark Daily reported in August.

Those labs included:

Testing capacity also has kept up with demand thanks to biology. Monkeypox, which is in the same orthopoxvirus family of viruses as smallpox, has proven far less virulent than COVID-19, so fewer people are getting infected.

FDA Advises Against Monkeypox Saliva Test

Another boost to capacity in the future may come from new types of monkeypox tests.

Wired reported on Aug. 1 that Flow Health—a California company already distributing COVID-19 tests—has developed a monkeypox test that can detect the virus in saliva. This test would require patients to spit into a tube for a sample, and as such could be distributed for at-home use.

However, in a report released on July 15, the US Food and Drug Administration (FDA) advised providers to only take testing samples from lesions caused by the rash associated with monkeypox infection. The FDA stated that there is currently no clinical data to support the use of other monkeypox tests like Flow Health’s.

Monkeypox Testing Resources Scarce in Some Areas

At the moment, clinical laboratory testing capacity seems stable, however, roadblocks are appearing that may disrupt the availability of monkeypox tests for patients.

Although bringing on five commercial laboratories has increased US testing capacity, MedTech Dive reported on Aug. 10 that for some hospitals and laboratories, resources for monkeypox testing are scarce.

For example, Bellevue Hospital in New York City, which is part of New York University’s Langone Health network, has had trouble dedicating space and staff for monkeypox testing.

“Right now, there’s a lot of confusion in the community about where to get tested, where can people find treatment,” Robert Pitts, MD, an Infectious Diseases Specialist at Bellevue, told MedTech Dive. “There’s just no clear guidance because I think a lot of the different facilities and healthcare systems in New York are still trying to patch together pathways. … We’ve had to borrow space, borrow staff, which has been really, really challenging.”

During August, Bellevue took two primary care providers out of their normal clinical responsibilities to instead focus on monkeypox. And Pitts found himself dedicating four to five hours of his time to monkeypox-related issues, MedTech Dive reported.

“And so, I’m using my own time, because it’s a crisis, to respond to it,” he said.

The US healthcare system has been somewhat more efficient at getting monkeypox tests out to clinical laboratories than was the case with COVID-19. Moreover, new tests may be on the way. However, roadblocks exist that must be overcome to ensure monkeypox testing capability will meet growing demand.

Ashley Croce

Related Information:

Senate HELP Committee Holds Hearing on Monkeypox Federal Response

CDC Tracks Monkeypox Outbreak

White House: Press Briefing by Press Secretary Karine Jean-Pierre and Covid-19 Response Coordinator Dr. Ashish Jha

Senate HELP Committee Holds Hearing on Monkeypox Federal Response

Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test

As Monkeypox Cases Increase, Disease Experts Lament Lack of Testing Access

Australian Researchers Develop a Superior Genetic Blood or Saliva Test for Detecting Glaucoma in High-risk Individuals

Should the test prove clinically viable, it could lead to new biomarkers for eye disease diagnostics and a new assay for clinical laboratories

Scientists at Flinders University in Australia have developed a genetic blood or saliva test that, they say, is 15 times more effective at identifying individuals at high risk of glaucoma than current medical laboratory tests.

If so, this discovery could lead to new biomarkers for diagnostic blood tests that help medical professionals identify and treat various diseases of the eye. Their test also can be performed on saliva samples. The researchers plan to launch a company later in 2022 to generate an accredited test that can be used in clinical trials.

“Early diagnosis of glaucoma can lead to vision-saving treatment, and genetic information can potentially give us an edge in making early diagnoses, and better treatment decisions,” said lead researcher Owen Siggs, PhD, Associate Professor, College of Medicine and Public Health at Flinders University, in a university press release.

Flinders University researchers have been collaborating with scientists at the QIMR Berghofer Medical Research Institute and other research institutes worldwide for some time to identify genetic risk factors for glaucoma, the press release noted.

The researchers published their findings in the peer-reviewed journal JAMA Ophthalmology, titled, “Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma.”

“In the cross-sectional study of monogenic and polygenic variants related to the disease, the new genetic test was evaluated in 2,507 glaucoma patients in Australia and 411,337 people with or without glaucoma in the UK. The test, conducted using a blood or saliva sample, could potentially detect individuals at increased risk before irreversible vision loss happens,” Medical Device Network reported.

Jamie Craig, PhD
“Genetic testing is not currently a routine part of glaucoma diagnosis and care, but this test has the potential to change that,” said Jamie Craig, PhD, (above), Distinguished Professor, College of Medicine and Health at Flinders University in Australia and senior author of the study, in a press release. “We’re now in a strong position to start testing this in clinical trials,” he added. This is yet another example of how new research is identifying a novel biomarker that could be incorporated into a clinical laboratory test. (Photo copyright: Flinders University.)

Who Is at Risk for Glaucoma?

Glaucoma is a group of eye diseases that are typically caused by a buildup of pressure within the eye. The eyeball contains and produces a fluid called aqueous humour which provides nutrition to the eye and keeps the eye in a proper pressurized state. Any excess of this fluid should be automatically released via a drainage canal called the trabecular meshwork.

But that’s not always the case. When the fluid cannot drain properly, intraocular pressure is created. Most forms of glaucoma are characterized by this pressure, which can damage the optic nerve and eventually cause vision loss and even blindness. Treatments for the disease include medications, laser treatments, and surgery.

Anyone can develop glaucoma, but according to the Mayo Clinic, individuals at higher risk of the disease include: 

  • Individuals over the age of 60.
  • Those with a family history of glaucoma.
  • People of African, Asian, or Hispanic descent.
  • Patients with certain medical conditions, such as diabetes, heart disease, high blood pressure, and sickle cell anemia.
  • Those with corneas that are thin in the center.
  • Individuals who have had a past eye injury or certain types of eye surgery.
  • People who have taken corticosteroid medications, especially eyedrops, for an extended period of time.

Glaucoma is the second leading cause of blindness worldwide, particularly among the elderly. When diagnosed early, the condition is manageable, but even with treatment, about 15% of glaucoma patients become blind in at least one eye within 20 years.

According to the federal Centers for Disease Control and Prevention (CDC), approximately three million Americans are living with glaucoma. The disease often has no early symptoms, which is why it is estimated that about 50% of individuals who have glaucoma do not realize they have the illness.

Thus, a clinically-viable genetic test that is 15 times more likely to identify people at risk for developing glaucoma in its early stages would be a boon for ophthalmology practices worldwide and could save thousands from going blind.

More research and clinical trials are needed before the Flinders University genetic test for glaucoma becomes available. But the discovery alone demonstrates the importance of continuing research into identifying novel biomarkers that could be incorporated into useful clinical laboratory diagnostic tests.

JP Schlingman

Related Information:

A Game-changer for Glaucoma Diagnosis: Scientists Develop a Blood Test That is 15 Times More Likely than Current Methods to Identify High-risk Individuals Before Irreversible Vision Loss Occurs

Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma

Flinders University Develops Genetic Test for Glaucoma

The Majority of Glaucoma Cases Remain Undiagnosed in the US

Glaucoma Test ‘Best Yet’

Aqueous Humor Flow and Function

Mayo Clinic: Glaucoma Causes and Symptoms

Glaucoma-Global Clinical Trials Review, H2, 2021

Don’t Let Glaucoma Steal Your Sight!