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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Researchers Find AI Improves Breast Cancer Detection by 20%

Initial analyses also shows AI screening lowers associated radiologist image reading workload by half

Both radiologists and pathologists analyze images to make cancer diagnoses, although one works with radiological images and the other works with tissue biopsies as the source of information. Now, advances in artificial intelligence (AI) for cancer screenings means both radiologists and pathologists may soon be able to detect cancer more accurately and in significantly less time.

Pathologists may find it instructive to learn more about how use of this technology shortened the time for the radiologist to sign out the case without compromising accuracy and quality.

Led by researchers at Lund University in Sweden, the Mammography Screening with Artificial Intelligence (MASAI) trial found that using AI during high-risk breast cancer screenings improved breast cancer detection by 20% without affecting the number of false positives, according to a Lund University news release.

Even better, AI screenings reduced doctors’ workload in interpreting mammography  images by nearly 50%, the news release states. Such an improvement would also be a boon to busy pathology practices were this technology to become available for tissue biopsy screenings as well. 

The researchers published their findings in the journal The Lancet Oncology titled, “Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study.“

“The greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading,” said breast radiologist Kristina Lång, MD, PhD, Associate Professor in Diagnostic Radiology at Lund University. Pathologists working with clinical laboratories in cancer diagnosis could benefit from similar AI advancements. (Photo copyright: Lund University.)

Can AI Save Time and Improve Diagnoses?

One motivation for conducting this study is that Sweden, like other nations, has a shortage of radiologists. Given ongoing advances in machine learning and AI, researchers launched the study to assess the accuracy of AI in diagnosing images, as well as its ability to make radiologists more productive.

The MASAI trial was the first to demonstrate the effectiveness of AI-supported screening, the Lund news release noted.

“We found that using AI results in the detection of 20% (41) more cancers compared with standard screening, without affecting false positives. A false positive in screening occurs when a woman is recalled but cleared of suspicion of cancer after workup,” said breast radiologist Kristina Lång, MD, PhD, clinical researcher and associate professor in diagnostic radiology at Lund University, and consultant at Skåne University Hospital, in the news release.  

Not only did the researchers explore the accuracy of AI-supported mammography compared with radiologists’ standard screen reading, they also looked into AI’s effect on radiologists’ screen-reading workload, the Lancet paper states.

Impetus for the research was the shortage of radiologists in Sweden and other countries. A Lancet news release noted that “there is a shortage of breast radiologists in many countries, including a shortfall of around 41 (8%) in the UK in 2020 and about 50 in Sweden, and it takes over a decade to train a radiologist capable of interpreting mammograms.”

That makes it even more challenging for providers to meet European Commission Initiatives on Breast and Colorectal Cancer (ECIBC) recommendations that two radiologists screen a woman’s mammogram, the Lancet news release pointed out.

More Breast Cancer Identified with Lower Radiologist Workload When Using AI Screening

Here are study findings, according to the Lancet paper:

  • AI-supported screening resulted in 244 cancers of 861 women recalled.
  • Standard screening found 203 screen-detected cancers among 817 women who were recalled.
  • The false positive rate of 1.5% was the same in both groups.
  • 41 (20%) more cancers were detected in the AI-enabled screening group.
  • Screen readings by radiologists in the AI-supported group totaled 46,345, as compared to 83,231 in the standard screening group.
  • Workload dropped by 44% for physicians using screen-reading with AI.

“We need to see whether these promising results hold up under other conditions—with other radiologists or other algorithms,” Lang said in the Lund news release.

“The results from our first analysis show that AI-supported screening is safe since the cancer detection rate did not decline despite a reduction in the screen-reading workload,” she added.

Is AI a Threat to Radiologists?

The use of AI in the Swedish study is an early indication that the technology is advancing in ways that may contribute to increased diagnostic accuracy for radiologists. But could AI replace human radiologists’ readings. Not anytime soon.

“These promising interim safety results should be used to inform new trials and program-based evaluations to address the pronounced radiologist shortage in many countries. But they are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” Lång cautioned. “We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology.”

In an Advisory Board daily briefing, breast radiologist Laura Heacock, MD, of the NYU Langone Perlmutter Cancer Center said, “If you spend a day with a radiologist, you’ll see that how an AI looks at screening a mammogram is really just a fraction of how radiologists practice medicine, even in breast imaging.

“These tools work best when paired with highly trained radiologists who make the final call on your mammogram. Think of it as a tool like a stethoscope for a cardiologist,” she added.

Whether a simple tool or an industry-changing breakthrough, pathology groups and clinical laboratories that work with oncologists can safely assume that AI advances will lead to more cancer research and diagnostic tools that enable earlier and more accurate diagnoses from tissue biopsies and better guidance on therapies for patients.   

—Donna Marie Pocius

Related Information:

How AI Improved Breast Cancer Detection by 20%

Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study

AI Can Detect Breast Cancer as Well as Radiologists, Study Finds

AI-Supported Mammography Screening is Found to be Safe

European Breast Cancer Guidelines

AI Use in Breast Cancer Screening as Good as Two Radiologists, Study Finds

COVID-19 Test Sales Fall Nearly 90% at Abbott in Q2, a Clear Marker to Clinical Laboratories That the Pandemic Has Passed

Sales of SARS-CoV-2 tests at other IVD companies, including Roche Diagnostics and Danaher’s lab businesses also report declines in COVID-19 test revenue

Clinical laboratory leaders and pathologists seeking a marker that the COVID-19 pandemic has passed may have it in the plunge in SARS-CoV-2 test revenue during the second quarter at Abbott Laboratories, Abbott Park, Illinois.

COVID-19 test sales in Q2 2023 at Abbott fell a “whopping” 89% as people try to “move on” from the SARS-CoV-2 outbreak, the Chicago Tribune reported.

Developer of the BinaxNOW rapid COVID-19 antigen self-test, Abbott saw its COVID-19 sales revenue decline from $2.3 billion in Q2 2022 to $263 million in the quarter ending June 30, the Chicago Tribune noted. 

The decline was expected by Abbott. Nonetheless, the company will likely sell more than $1 billion in COVID-19 tests by the end of this year—business it did not have in 2019.

Abbott lowered its forecast for COVID-19 sales in 2023 to $1.3 billion, down from $1.5 billion, MedTech Dive reported.

“We decided to bring our COVID-19 number down a couple of hundred million dollars, because we’re seeing—as the public health emergency ended—a little bit of a decline in testing,” said Abbott’s Chairman and CEO Robert Ford during an earnings call transcribed by Motley Fool. “So, we’ll see how that’s going to play out in Q4 (2023), the first quarter we will see an endemic respiratory season.” Clinical laboratories that performed high numbers of SARS-CoV-2 test during the pandemic will likely experience similar declines in test volumes. [Photo copyright: Abbott Laboratories.)

Overall, Abbott Has ‘Good Recovery’

COVID-19-related diagnostics was just part of the financial report by Abbott, which also develops other clinical laboratory tests, clinical laboratory analyzers and automation, medical devices, pharmaceuticals, and nutritional products such as infant formula.

Abbott said in a news release that its sales—driven by base business performance—were $10 billion in Q2.

“We have had a really, really good recovery here as the health systems are opening up, and are seeing routine testing come back,” said Abbott’s Chairman and CEO Robert Ford during the earnings call.

Here are diagnostics financial results for Q2 2023 as compared to Q2 2022, according to the news release:

  • Diagnostic sales fell to $2.3 billion from $4.2 billion.
  • Core laboratory sales were flat at $1.2 billion.
  • Molecular sales plunged to $141 million from $212 million.
  • Rapid diagnostics plummeted to $741 million from $2.7 billion.

As need for COVID-19 testing contracts, Abbott is focusing on research and development of assays that may be “missing on the menus,” Ford said during the earnings call.

“We’ve been working on expanding the menu in molecular and point-of-care. One of the most exciting assays that the team has developed for point-of-care is a rapid test for traumatic brain injury,” he added.

COVID-19 Revenue Falls at Roche, Danaher

Abbott is not the only in vitro diagnostics (IVD) manufacturer to report a recent significant decline in demand for COVID-19 products.

Another sign the major wave of the pandemic has passed is the dramatic fall in COVID-19 product revenue at Roche to 0.4 billion Swiss Francs (CHF) (US$460 million) from 3.1 billion CHF (US$3.5 billion) in the first half of 2022, according to a Roche news release.

The Basel, Switzerland company—reporting on six months of financial results—said its Roche Group base business increased 8% and Diagnostics Division base business rose 6% in 2023, as compared to the first six months last year.

Diagnostics Division sales overall fell 23% to 7 billion CHF (US$8 billion) from 9.9 billion CHF (US$11.3 billion), Roche said.

Here are more first-half of 2023 financial results at Roche as compared to the same period in 2022:

  • Core lab: 3.9 billion CHF ($US 4.4 billion), up 10% from 3.8 billion CHF (US$4.3 billion).
  • Molecular lab: 1.1 billion CHF (US$1.2 billion), down 40% from 1.9 billion CHF (US$2.1 billion).
  • Diabetes care: 723 million CHF (US$831.7 million), down 5% from 832 million CHF (US$957 million).
  • Pathology lab: 687 million CHF (US$790 million), up 12% from 652 million CHF (US$750 million).
  • Point of care: 635 million CHF (US$730.6 million), plummeted 74% from 2.6 billion CHF (US$2.9 billion).

“In the first half of 2023, sales in the base business of both of our divisions (diagnostics and pharmaceuticals) grew strongly, largely offsetting the impact of declining demand for COVID-19 products,” said Roche CEO Thomas Schinecker, PhD, in the news release.

COVID-19 test revenue also impacted financial results at Danaher Corporation, the Washington, D.C.-based parent company of Beckman Coulter Diagnostics, Cepheid, and Leica Biosystems.

Revenue was down in Q2 7.5% to $7.1 billion as compared to $7.7 billion in the same quarter last year, the company said in a news release.

COVID-19 took a toll on sales of 9% in the quarter as compared to Q2 2022, according to a Danaher earnings release presentation.

As to plans for growth, Cepheid is adding assays for Group A Streptococcal and hospital-acquired infections to the menu of the GeneXpert System which performs COVID-19 testing, said Danaher CEO Rainer Blair in remarks to analysts during an earnings call prepared by the Weekly Transcript.

COVID-19 May Linger as IVD Companies Refresh Menus

As the COVID-19 pandemic wanes, healthcare providers will continue to test patients for the SARS-CoV-2 coronavirus.

But it also appears that IVD companies are aiming to keep their instruments—which ran full tilt performing COVID-19 testing during the pandemic—of high value to clinical laboratories by developing new tests for possible inclusion on labs’ testing menus.

—Donna Marie Pocius

Related Information:

Abbott’s COVID-19 Test Sales Dive by Nearly 90%

Abbott Q2 Net Profit Falls as Weaker COVID-19 Test Sales Drag on Revenue

Abbott Laboratories Q2 2023 Earnings Call Transcript

Abbott Reports Second Quarter 2023 Results, Increases Outlook for Underlying Base Business

Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion

Roche Reports Strong Growth in Both Divisions’ Base Business; Group Sales Reflect Declining Demand for COVID-19 Products

Danaher Reports Second Quarter 2023 Results

Danaher Earnings Presentation

Danaher Q2 2023 Earnings Call Transcript

Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand

Strike may delay critical blood testing and cause postponement of many surgical procedures

Medical technicians, phlebotomists, and clinical laboratory scientists in New Zealand are once again going on strike for fairer pay in various areas around the island nation. And their complaints mirror similar complaints by healthcare and clinical laboratory workers in the US.

The latest group of New Zealand medical laboratory workers to strike are in the South Island and Wellington regions. They were scheduled to walk off the job on July 28 after a negotiated agreement was not reached between APEX, a “specialist union representing over 4,000 allied, scientific, and technical health professionals,” according to the union’s website, and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

Medical laboratory workers in New Zealand are among some of the poorest paid healthcare professionals in the country’s medical industry, according to New Zealand Institute of Medical Laboratory Science President Terry Taylor who told the New Zealand Doctor that some workers aren’t making a living wage. “These people worked their butts off during the pandemic, so you’d think [Awanui] would be able to come up with a decent offer for its staff,” Taylor said.

On the picket line, New Zealand phlebotomists and medical laboratory technicians express that they do not feel they are being compensated properly. “Without your blood samples, you don’t get your results, you don’t get your treatments, you don’t get admissions, your hospital appointments, your operations,” a phlebotomist told 1News. Clinical laboratory workers in the US who experienced the enormous pressure during the COVID-19 lockdowns would likely agree. (Photo copyright: Otago Daily Times.)

Phlebotomists and lab workers in an around New Zealand are demanding a pay wage to put them on par with healthcare workers in the public sector. According to The Southland Times this raise would average around 23.5%.

However, to date Awanui has only offered the medical laboratory workers a 5% pay increase. The APEX union says that is far below what is acceptable for them.

“It doesn’t even get them to parity with colleagues from the public hospitals, and with inflation the way it is at the moment, it’s effectively a wage cut. So, it looks like these strikes are continuing,” David Munroe, Apex Union Advocacy Lead, told 1News New Zealand.

Patients in these regions can expect to see delays on blood test results as medical laboratories and phlebotomy collection centers close due to the strike action.

Poorest Paid Health Professionals in New Zealand

Last year, Dark Daily reported on a similar strike of New Zealand’s 10,000 healthcare workers—including its 4,000 medical laboratory scientists and technicians—which was scheduled to take place in March.

In “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered how a last-minute court injunction stopped the mass walkout just 24 hours before it was to begin because of a rise in COVID-19-related hospitalizations.

That strike was also over low pay and poor working conditions.

This year, unionized workers met with Awanui on May 23, but the company declined to make an offer to prevent the strike. A second day of bargaining was scheduled for May 24, but according to Munroe, Awanui refused to show up for negotiations. However, Vicki McKnight, an Awanui General Manager, claimed the company was willing to come to the table but that “APEX declined,” New Zealand Doctor reported.

“To date, there has only been one day of bargaining and the collective agreement has not yet expired, so we are surprised by the comments on potential industrial action after just one day of negotiations,” McKnight told New Zealand Doctor.

McKnight said the parties were unable to come to an agreement because of a significant gap between the claims the parties brought to the bargaining table.

Awanui Pays Out Dividends in the Millions

In reaction to workers taking to the picket line, Awanui Labs acknowledged the strike. The company’s Chief People Officer Emma Kelly told 1News, “We do value our people, and it’s a difficult position to be in strikes for our people, for our patients, for everyone. So, I just want to go into this situation with empathy and respect for all of those involved.”

However, one of the things the New Zealand clinical laboratory workers took particular issue with, in light of Awanui’s 5% offer, was that in the last financial year Awanui paid out $41 million in dividends to its shareholders. According to Munroe, the workers want the company to invest in them—instead of the shareholders.

“They are the business. You can’t run laboratories without scientists, technicians, and phlebotomists. They know it, and it’s about time the company knows it too,” Munroe told 1News.  

The medical laboratory workers plan to remain on the picket line until a deal is made.

Clinical laboratory managers in the US should take heed of what the New Zealand strikers are saying about low pay and poor working conditions—situations mirrored in many nations following the COVID-19 pandemic.   

—Ashley Croce

Related Information:

Blood Test Delays on the Way as Workers Prepare to Strike

Lab Workers Gearing Up for Second Full Strike

Awanui Laboratory Workers to Strike Over Pay Offer

Country’s Biggest Medical Lab Provider Facing Strike Action

‘Can’t Live on These Wages’: Lab Workers Begin Strike Action

Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions

Global Biolabs 2023 Report Shows Most Dangerous Pathogen Testing Laboratories across the Globe

Of 27 BSL-4 labs assessed, Global Biolabs ranked only seven as having ‘good’ biosafety management

In a new report, a research firm assessed the conditions at the handful of laboratories across the world that handle the most dangerous pathogens. In the wake of the SARS-CoV-2 global pandemic, there is heightened awareness of the risks of a lab accident that might release such pathogens into the environment, putting humans at risk.

Medical laboratory scientists working in clinical laboratories worldwide understand the critical nature of biosafety laboratory (BSL) criteria. Nearly all clinical laboratories that test for infectious disease agents are biosafety level-1 and -2 (BSL-1, BSL-2).

Other high-containment laboratories (HCL) that handle deadly, highly transmissible pathogens are typically government-run or university-affiliated. HCL labs have BSL-3 and BSL-4 levels and require rigorous adherence to protocols that ensure worker safety and prevent escape of dangerous pathogens.

Thus, the new report from Global Biolabs, which is critical of biorisk management protocols at existing and planned BSL-4 laboratories—especially given the increasing construction of new HCL labs worldwide—will be of interest to medical technologists, pathologists, and clinical scientists working with highly infectious diseases.

The biosafety experts who make up the Global Biolabs research team conduct risk-assessments and “provide key policy recommendations for strengthening biorisk management in BSL-4 labs,” according to the organization’s website.

Many countries did not fare well in Global Biolabs’ analysis of their policies. “The report urges the World Health Organization to strengthen guidance and individual countries to agree to audits by outside experts to ensure that their labs meet international standards,” Science reported in “Growing Number of High-Security Pathogen Labs Around World Raises Concerns.”

“The more labs and people working with dangerous pathogens, the risks go up,” biosecurity expert Filippa Lentzos, PhD (above), Associate Professor, Science and International Security, King’s College London, told Science magazine. Lentzos was part of the team that created the Global Biolabs mapping project two years ago. Clinical laboratory managers may want to review the findings in the Global Biolabs report. (Photo copyright: King’s College London.)

Only Seven Out of 27 Countries Get ‘Good’ Overall Score

“The boom in BSL-4 lab construction appears, so far, not to have been accompanied by strengthened biorisk management oversight,” according to the Global Biolabs 2023 report from the Global Biolabs Initiative. “Additionally, most planned BSL-4 labs will be in countries with relatively low scores for governance and stability,” the report’s authors wrote.

The report included a ranking of countries by total biorisk management score, the Daily Mail noted, adding:

  • Of 27 countries analyzed, seven ranked as good (above 70%) for biorisk policies,
  • 15 scored medium (above 30%),
  • five scored below.

Those with the best biorisk management scores (maximum 48):

  • Canada scored 46 (96%),
  • US scored 42 (88%),
  • Australia and the United Kingdom each scored 40 (83%).

Notably, China “scored zero on modifying pathogen rules.” According to the Daily Mail, “China’s overall management score (33) was in the middle of the pack, 69%.”

More Labs, More Danger

The Global Biolabs Initiative was launched in 2021 by Filippa Lentzos, PhD,

Associate Professor in Science and International Security, King’s College London, and Gregory Koblentz, PhD, Associate Professor and Director Biodefense Graduate Program, George Mason University, Fairfax, Virginia. The organization tracks maximum containment labs worldwide, noting trends that raise biosafety and biosecurity concerns.

According to the Daily Mail, Lentzos noted “that a particular worrying aspect of the BSL-4 boom was those countries looking to open their first lab were the bottom scorers in terms of good biorisk management.

“Many of the countries building new labs, some for the first time, score poorly on biorisk management. However, there is still time to strengthen national laws and regulations on biosafety, biosecurity, and dual-use research [biological research that could cause harm] to bring them up to international standards,” the Global Biolabs researchers wrote in their report.

Global Mapping of BSL-4 Labs

There are 51 BSL-4 labs operating worldwide, and 18 are planned or under construction, according to Global BioLab’s report. Here’s where they are located:

  • Europe: 24
  • North America: 12
  • Asia: 9
  • Oceania: 4
  • Africa: 2
  • South America: 0

Also, BSL-3+ labs total 55:

  • Europe: 21
  • North America: 18
  • Asia: 10
  • South America: 3
  • Africa: 2
  • Oceania: 1

The report also noted:

  • Of the 18 BSL-4 labs under construction, 11 are planned to open in Asia.
  • About half of BSL-4 labs are “less than the size of a tennis court.”

“Eighty percent (of BSL-4 labs) are located in urban areas, which heightens concerns about accidents at these facilities,” Koblentz told the Daily Mail.

According to Science, the number of BSL-4 labs has doubled since 2013. Growth in BLS-4 labs began around the time of the 2001 anthrax attacks and picked up speed in 2003 following the SARS outbreak, University World News reported.

Biosecurity and Biosafety Analyzed

Global Biolabs’ analysis included countries’ biosecurity and biosafety scores. Just 12 out of 27 countries with BSL-4 labs scored high on biosecurity, nine scored medium, and six scored low.

A high score for biosecurity—which US and France received—reflects laws for biosecurity, a national list of dangerous pathogens, and whistleblower protection.

Out of 27 countries, 21 with BSL-4 labs scored high on biosafety. However, two countries scored medium, and four scored low. The two countries that earned the highest scores for biosafety—Canada and Australia—have physical/engineering controls, occupational health, and transportation safety, among other areas reviewed.

Opportunities for Improvement

Global Biolabs made the following recommendations in their report:

  • Nations with BSL-4 and BSL-3 labs need to have in place biorisk management systems including comprehensive laws, regulations, and institutions that require safety and security risk assessments of proposed research.
  • Strengthening of biorisk management is called for by the World Health Organization and Biological Weapons Convention.
  • Labs, of all biosafety levels, are advised to aim toward safety, security, and responsible research. 

The effort by Global BioLabs to create a public record of how each BSL-4 and BSL-3 laboratory adheres to strict standards of safety and operations demonstrates that some degree of risk exists in the operation of these labs. Whether government and world health authorities make it a priority to address known deficiencies in those labs is a question yet to be answered.  

—Donna Marie Pocius

Related Information:

Global Biolabs Report 2023

Dangerous Labs Ranked, and China Scores Zero When It Comes to Safety in Handling “Risky” Experiments on World’s Most Dangerous Pathogens

Growing Number of High-Security Pathogen Labs Around World Raises Concerns

Lab Leak Most Likely Origin of COVID-19 Pandemic, Energy Department Now Says

China Rejects US Assertion that COVID-19 Originated from Lab Leak

It’s Boom Time for Biosafety Labs: Who is Keeping Tabs?

CDC: Biological Risk Assessment, General Considerations for Laboratories

US Army’s Only Deployable Medical Laboratory Highlights Its Mission during Trip to Poland

As a deployable medical laboratory, the 1st AML is designed to run field-based clinical laboratory diagnostics and conduct health threat assessments

Clinical laboratory professionals may be surprised to learn that the US Army has a deployable medical laboratory that is equipped to perform the same menu of basic lab tests as their labs here in the United States, but in support of army units deployed in the field. At the same time, the Army’s deployable medical lab has the added responsibility of testing for infectious diseases and chemicals/agents that could be used by terrorists or enemy forces.

The 1st Area Medical Laboratory (AML) is based out of Aberdeen Proving Ground, Maryland, and operates within the Army’s 20th Chemical, Biological, Radiological, Nuclear and Explosives Command (CBRNE).

“The 1st Area Medical Laboratory identifies and evaluates health hazards through unique medical laboratory analyses and rapid health hazard assessments of nuclear, biological, chemical, endemic disease, occupational, and environmental health threats,” according to an Army new release.

A recent visit by the leaders of this lab unit to meet with their counterparts in Poland highlights the important diagnostic work the military prepares for by using this one-of-a-kind clinical laboratory model.

Col. Matthew Grieser and Col. Przemyslaw Makowski, MD

Col. Matthew Grieser (left), Commander of the 1st Area Medical Laboratory (AML) is shown above meeting with Col. Przemysław Makowski, MD, (right), Deputy Commander of the Military Preventive Medicine Center in Wrocław, Poland. Leaders from the US Army’s 1st AML visited military and medical officials in Poland. “It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Grieser in an Army news release. “We intend to continue to strengthen this relationship … Poland is a great ally, and it was an honor to visit our counterpart organizations.”  (Photo copyright: US Army.)

Role and Makeup of the 1st Area Medical Laboratory

The 1st AML traces its roots back to World War II, where it was one of 19 field laboratories spun up in 1944. It was deactivated after the Vietnam War and then reactivated in 2004. It is currently the Army’s only deployable field laboratory, according to the National Library of Medicine.

This specialized unit deploys worldwide to conduct threat detection and medical surveillance, according to the Army. For example, the military can send the 1st AML to locations where samples cannot quickly be transported to a fixed facility, or where there is a need for immediate hazard identification due to chemical or biological contamination or epidemic disease.

During the Ebola outbreak in Liberia in 2014-2015, the 1st AML operated four blood-testing laboratories and helped oversee two others manned by Navy personnel. The goal was to perform quick turnaround times to identify local residents who carried the disease, all while operating with extensive safety measures. More than 4,500 samples were tested during a six-month stay, Army Times reported.

As Dark Daily covered in “New High-Tech Mobile Medical Laboratories Deployed by the US Navy and a European Consortium Use Genetic Analysis to Get Rapid Diagnosis of Ebola,” one of the Navy labs located at Liberia’s capital, Monrovia, was able to reduce turnaround times for Ebola tests from days to hours.

The unit’s technical expertise features a combination of scientists, clinicians, and certified technicians. Familiar lab personnel include a microbiologist, a biochemist, and medical laboratory technicians.

1st AML Leaders Visit Polish Counterparts

Commanders from the 1st AML recently met with medical officials and chemical, biological, radiological, and nuclear experts from the Polish Armed Forces in the Warsaw area of Poland, the Army news release noted.

During the weeklong trip, 1st AML leaders toured the Epidemiological Response Center of the Polish Armed Forces, Military Institute of Chemistry and Radiometry, laboratories at the Polish Military Institute of Medicine, and biological and chemical labs at the Military Center for Preventive Medicine.

“It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Col. Matthew Grieser, Commander of the 1st AML.

Maj. Suzanne Mate, the Chief of chemical threat assessment for the 1st AML, said meeting with allies helps to keep NATO ready for any contingency.

“It’s better to know your partners before you have to work together in a high-consequence situation,” said Mate in the Army news release. “We learned the strengths in different mobility platforms for laboratories and the capabilities within fixed scientific institutions to maintain standards and currency in chemical, biological, and radiological [CBR] investigations.

“This knowledge is invaluable when determining how to move a sample quickly and efficiently to characterize a suspected CBR threat when airlift resources are constrained or country treaties prevent movement activities,” she added.

Observant clinical laboratory managers will note similarities between their own jobs and those of the 1st AML. The military needs lab-based capabilities to perform a menu of diagnostic tests in support of Army units in the field and traditional clinical laboratories do the same in support of the healthcare providers they service.

Scott Wallask

Related Information:

US Army Field Medical Laboratory Leaders Meet with Polish Counterparts in Warsaw

1st Area Medical Laboratory to Deploy for Ebola Mission

Army Lab Unit Earns Award for Ebola Response in Liberia

New High-Tech Mobile Medical Laboratories Deployed by the U.S. Navy and a European Consortium Use Genetic Analysis to Get Rapid Diagnosis of Ebola

Examining the Utility and Readiness of Mobile and Field Transportable Laboratories for Biodefence and Global Health Security-Related Purposes

Might Phlebotomy Become Fully Automated? Dutch Company Is Working to Develop World’s First Autonomous Blood-drawing Station

Should this AI-driven technology prove viable in clinical settings, it could contribute to easing the shortage of qualitied phlebotomists for medical laboratories worldwide

Could phlebotomists one day be out of a job? If European medical technology company Vitestro has its way, that could someday become a reality in European hospitals and in clinical laboratories worldwide. Headquartered in the Netherlands, the company has raised EUR 12.7 million ($14,057,947.50 US) in Series A financing to bring to market “the world’s first autonomous blood drawing device,” BioWorld Med Tech reported.

According to Vitestro’s website, the “device combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion, ensuring accurate and secure blood collection. The procedure is performed fully automatically, from tourniquet to bandage application.”

This is another example of how artificial intelligence companies are finding opportunities in staffing shortages the healthcare industry is experiencing globally. In this case, the novel technology could help address the lack of qualified phlebotomists. And clinical laboratories around the world could become the proving grounds for new AI-driven devices that end up replacing human healthcare workers.

Toon Overbeeke

“This financing round marks a new phase of growth for Vitestro which brings the company closer to its mission of improving the venipuncture procedure for hundreds of millions of patients per year,” said Vitestro CEO and co-founder Toon Overbeeke (above), in a press release. “We look forward to growing the business and transforming patient care with Sonder Capital, leveraging their expertise in successfully commercializing medical robotic technologies.” If proven viable, clinical laboratories around the world suffering from shortages of phlebotomists could benefit from AI-driven autonomous blood draw stations. (Photo copyright: LinkedIn.)

Next Evolution for Clinical Laboratories

According to the Centers for Disease Control and Prevention (CDC), there are 14 billion clinical laboratory tests ordered annually in the US and 70% of medical decisions depend on laboratory results. One of the more common clinical laboratory procedures—venous blood draws—is pivotal in clinical diagnostics, but a worldwide shortage of skilled phlebotomists is having an impact on this critical testing method. 

With the announcement of its completion of a EUR 12.7-million Series A financing round to bring the “world’s first” autonomous blood draw device to market, Vitestro seems poised to impact both the shortage and the job prospects of existing phlebotomists. This financing round was led by San Carlos, California-based Sonder Capital and included investors with experience in the clinical laboratory and medical technology industries. 

“Automating this ubiquitous procedure is the next evolution for clinical laboratories, allowing them to improve quality of care for patients while building a more sustainable operation,” stated Andy McGibbon, Managing Partner at Sonder Capital in a March press release

According to Investopedia, Series A financing refers to “an investment in a privately-held start-up company after it has shown progress in building its business model and demonstrates the potential to grow and generate revenue. It often refers to the first round of venture money a firm raises after seed and angel investors.”

Vitestro says it will utilize the capital from this financing round to accelerate production development, prepare market authorization in the European Union, and initiate production. 

Vitestro's autonomous blood drawing machine

Vitestro’s autonomous blood drawing device prototype (above) has been tested on more than 1,000 volunteers and patients. Vitestro plans to continue its studies on the device this year and anticipates entering the European market with the device sometime in 2024. Development of this technology is something that phlebotomists and clinical laboratory managers will want to track. (Photo copyright: Vitestro.)

Coming to a Clinical Laboratory Near You

“Medical robotics will make optimal outcomes available to everyone. I strongly believe Vitestro will set the world standard in autonomous blood drawing,” said Fred Moll, MD, Managing Partner of Sonder Capital in the press release. Moll, who has been heralded as the “father of robotic surgery,” was also appointed as a non-executive board member of Vitestro. Moll co-founded Intuitive Surgical, Inc., Hansen Medical, Restoration Robotics, and Auris Health (acquired by Ethicon, a Johnson and Johnson company).

On April 12, Vitestro announced that leading Dutch clinical laboratory OLVG Lab will be the first healthcare provider to begin using their blood-drawing device. A number of hospitals, clinical laboratories, and blood drawing departments are preparing to use the device and OLVG Lab plans to have the system fully operational by late next year, according to a press release. OLVG lab provides laboratory services to hospitals, clinics, and care providers in the greater Amsterdam area. 

“Robotization has become an important topic in diagnostics. Vitestro’s technology will improve the standardization and optimization of the sampling procedure. And it helps solve staff shortages in our blood drawing department,” said Anja Leyte, director of OLVG Lab, in the press release. “But more importantly, the patients are also very positive. Our staff are really enthusiastic as well and can’t wait to start using this breakthrough technology in our healthcare.”

Vitestro’s device is still in the testing phase but could prove to be very beneficial to clinical laboratories and help alleviate the shortage of trained phlebotomists. An automated blood draw machine might also improve the consistency of the blood draw experience for both patients and healthcare professionals.   

—JP Schlingman

Related Information:

Vitestro Raises EUR 12 Million in Series A Financing Round to Bring the World’s First Autonomous Blood Drawing Device to the European Market

Amsterdam-based OLVG Lab Adopts Vitestro’s Autonomous Blood Drawing Devices

Rutgers University Researchers Develop Desktop Venipuncture Robot Capable of Drawing Blood Samples and Rendering Analyses Outside of Medical Laboratories

Artificial Intelligence and Computational Pathology

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