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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Walgreens, CVS Add New Healthcare Services and Technology to Their Retail Locations; Is Medical Laboratory Testing Soon to Be Included?

Expanding healthcare services into communities is expected to increase orders for clinical laboratory tests, promote precision medicine, and lower overall costs

Clinical laboratories continue to adapt to servicing providers in non-traditional healthcare settings. These include freestanding urgent care centers as well as mini-clinics in retail locations. Dark Daily has covered this trend extensively in previous e-briefings.

To secure a share of this new market, national retailers, pharmacy chains, and grocery stores are increasing their health and medical service offerings and forging partnerships with other organizations, such as tech developers.

One such recent partnership involves Walgreens Boots Alliance Inc. (NYSE:WBA) and the Microsoft Corporation (NASDAQ:MSFT). In January, both parties announced a joint venture to develop new healthcare solutions that will improve patient outcomes while lowering cost through research and development, funding, and technology.

“Our strategic partnership with Microsoft demonstrates our strong commitment to creating integrated, next-generation, digitally-enabled healthcare delivery solutions for our customers, transforming our stores into modern neighborhood health destinations, and expanding customer offerings,” said Stefano Pessina, Executive Vice Chairman and Chief Executive Officer of Walgreens, in a Microsoft press release.

Through this partnership, Walgreens plans to provide personalized healthcare (aka, precision medicine) by connecting its customers to pertinent health information through digital devices and in-store expert advice. The goal is to proactively engage patients in their own care to improve medication adherence, reduce emergency room visits, decrease hospital readmissions, and provide customers with lifestyle management solutions.

In addition, the two companies will share each other’s market research and work with consumers, payers, providers, and pharmaceutical manufacturers to devise solutions that improve health outcomes while lowering costs.

“[Walgreens Boot Alliance] will work with Microsoft to harness the information that exists between payers and healthcare providers to leverage, in the interest of patients and with their consent, our extraordinary network of accessible and convenient locations to
deliver new innovations, greater value, and better health outcomes in healthcare systems across the world,” Pessina said in the press release.

As part of this partnership, Walgreens will move the majority of its IT infrastructure onto Microsoft Azure, a cloud computing and artificial intelligence (AI) platform. Walgreens also will provide Microsoft 365 to more than 380,000 employees and stores located throughout the world. Microsoft 365 is a business solution which bundles Windows 10 and Office 365 with advanced security features.

Other Walgreens Collaborations That Provide Healthcare at Retail Locations

Walgreens also announced several collaborations with other companies to become more competitive and secure their share of the healthcare market.  

Through its partnership with Chicago-based VillageMD, a national provider of primary care clinics, Walgreens will open five primary care clinics next to Walgreens stores in the Houston area. These clinics, called “Village Medical at Walgreens,” will offer customers comprehensive primary care services, pharmacists, nurses, and social workers.


“This collaboration with VillageMD demonstrates our ongoing commitment to create neighborhood health destinations that bring affordable healthcare services to customers and provide a differentiated patient experience to the communities we serve,” stated Patrick Carroll, MD (above), Chief Medical Officer, Clinical Programs and Alliances, Walgreens, in a Walgreens press release. “VillageMD has a strong track record nationally of improving outcomes and reducing the cost of healthcare through their transformative primary care model.” (Photo copyright: Walgreens.)

Another collaboration involves Verily Life Sciences, a research arm of Alphabet Inc. (NASDAQ:GOOG), Google’s parent company. The agreement is for multiple projects to improve health outcomes for patients with chronic illnesses. The two companies will be exploring the use of technology, such as sensors, and software to help prevent, manage, screen, and diagnose disease with the ultimate goal of deploying those technologies at Walgreens retail locations. 

“The continued rise in chronic diseases today can be costly to patients as well as to our healthcare system,” Pessina told Business Wire. “Working with Verily, we’ll look at how we can best support integrated and value-based care to meet our patients’ needs, as well as opportunities to address other chronic conditions over time.”

Service Agreements with LabCorp and Quest

In 2018, Walgreens announced a significant expansion of their collaboration with LabCorp, to increase the number of patient service center (PCS) locations within Walgreens stores. The two companies agreed to open at least 600 additional LabCorp-at-Walgreens facilities across the US over the next four years. At the time of the announcement, LabCorp operated 17 facilities at Walgreens in Florida, Colorado, North Carolina, and Illinois.

Along the same lines, Quest Diagnostics (NYSE:DGX) also has opened hundreds of patient-serviced centers within various food and drug retail stores throughout the US, which Dark Daily reported in 2017.

“Healthcare is too complicated, too big, and if I can say, a little too messy,” Pessina told Digital Commerce 360. “We cannot be helpful to our patients if we don’t team up with many, many different, practically all, the players in this industry.”

CVS HealthHubs Offer Blood Testing, Health Screenings, and Other Services

To remain competitive, CVS also is trying new ways to capitalize on the growing healthcare market.

In February, CVS announced the creation of three newly designed stores in the Houston area as pilot projects. These stores, called HealthHubs, will include expanded health clinics with medical laboratories for blood testing and health screenings. They’ll also feature dieticians, respiratory specialists, and dedicated space to assist customers with the management of some chronic health conditions, as well as wellness rooms for yoga classes and health seminars.

“We’re pleased and surprised pleasantly with the ecosystem of healthcare that we’ve created here and how approachable it is, how much people are interested in it, and there are certain things we can take to all stores,” Kevin Hourican, Executive Vice President, CVS Health and President, CVS Pharmacy, told Becker’s Hospital Review

With more retailers adding an ever-increasing number of healthcare services to their offerings, the number of medical laboratory tests available at those locations will likely also increase. Although this trend may boost competition for clinical laboratories, it could also benefit them by creating new opportunities to provide value-added services to their clients.

—JP Schlingman

Related Information:

Microsoft, Walgreens Team up to Develop New Healthcare Delivery Models

Walgreens Boots Alliance and Microsoft Establish Strategic Partnership to Transform Health Care Delivery

CVS Unveils HealthHub Store Design

Walgreens and VillageMD to Offer Primary Care Services in the Houston Area

Walgreens Boots Alliance and Verily Announce Strategic Partnership to Innovate on New Solutions to Improve Health Outcomes

Walgreens and LabCorp to Open at Least 600 LabCorp at Walgreens Patient Service Centers

Walgreens Works with Microsoft to Design Digital Health Corners in Stores

UnitedHealth Group’s MedExpress and Walgreens Boots Alliance Initiate Pilot Program to Put Urgent Care Centers in Walgreens Pharmacies

CVS Announces Plans to Add More Clinical Services to Its Minute Clinic Locations, Including Certain Medical Laboratory Tests

Patients Who Post Negative Comments about Healthcare Experiences on Social Media Review Sites Are Being Sued by Physicians and Hospitals; Clinical Laboratories Might Be Similarly Vulnerable to Being Drawn into Lawsuits

Defamation, libel, harassment, and causing emotional distress are some of the charges patients who launched online negative review campaigns are defending themselves against in court

Healthcare systems, surgeons, family practitioners, clinical laboratories, anatomic pathologists—none are immune to receiving negative online reviews from patients who believe they’ve been damaged by their caregivers. And these reviews can have such an impact on practice revenues, doctors and hospitals have begun suing patients for damages caused by harmful online reviews. And they are winning.

Several notable cases involve high-profile healthcare systems. One such lawsuit involved the Cleveland Clinic. A patient who claimed a 2008 prostate surgery left him impotent and incontinent due to negligence on the part of the surgeon launched a negative campaign that spanned a decade, USA Today reported.

David Antoon, a retired Air Force Colonel, filed a malpractice lawsuit against urologist, Jihad Kaouk, MD, and the Cleveland Clinic. Antoon alleged Kaouk was not present in the operating room during his surgery, even though he insisted that only Kaouk perform the procedure. Antoon also claimed the Cleveland Clinic’s urology department did not have the proper credentials to operate the robotic device used during his surgery.

In addition to filing the lawsuit, Antoon complained to the federal Centers for Medicare and Medicaid Services (CMS) and the State Medical Board of Ohio.

However, Antoon also vented his frustrations on social media, as well as sending e-mails to Kaouk, which the doctor felt were threatening and made him concerned about the situation escalating. “What would be next—showing up at my door?” Kaouk asked during the criminal trial against Antoon. “That’s what we feared.”

Jihad Kaouk, MD (above), a urologist with the Cleveland Clinic, giving testimony at Cuyahoga County Common Pleas Court during a lawsuit involving patient David Antoon, a retired Air Force Colonel. Kaouk and the Cleveland Clinic prevailed in that lawsuit and the State Medical Board of Ohio closed a five-year investigation into Kaouk without reprimanding him. (Photo copyright: USA Today.)

Antoon posted unfavorable online comments about Kaouk for a decade. The urologist eventually petitioned the court, which granted him a civil stalking protective order against Antoon. It banned Antoon from contacting the doctor. Nevertheless, the day after that order was granted, Antoon posted another bad review about Kaouk on Yelp and urged people to avoid Kaouk when seeking medical care.

Antoon was later arrested on felony charges of menacing by stalking, telecommunications harassment, and violating a protection order. He faced up to one year in prison if indicted. In addition to spending two days in jail, he paid $40,000 for a defense attorney and a $50,000 bond after being arrested. He also agreed to pay $100 as part of a plea deal.

Above is David Antoon (left), Col USAF Ret, and Don Malarcik (right), an attorney with Malarcik, Pierce, Munyer, and Will in Akron, Ohio. Malarcik argued that “the Yelp review doesn’t violate the protection order because Antoon did not make direct contact with Kaouk,” Cleveland.com reported. (Photo copyright: USA Today.)

Other Lawsuits Against Patients Involving Social Media

Joon Song, MD, PhD, a New York City area gynecologist sued patient Michelle Levine over critical reviews she left about his practice on several online sites. Though Levine removed her posts from the sites after being sued, Song wants her to pay $1 million in legal fees and damages. The doctor accused Levine of defamation, libel, and causing emotional distress. Sound familiar?

Two Scottsdale, Ariz., doctors—Albert Carlotti, MD, and Michelle Cabret-Carlotti, MD, DDS,—successfully sued patient Sherry Petta for defamation after she posted negative statements about the doctors online. After filing a complaint with the Arizona Medical Board and clashing with Carlotti over access to her medical records, Petta posted unfavorable reviews about the practice on several online sites and created a website to warn others about Carlotti. The doctors claimed the statements Petta made were untrue and portrayed them in a false light. A jury agreed and awarded the doctors $12 million, which was later vacated on appeal.

Cleveland cosmetic surgeon Bahman Guyuron, MD, sued a former patient after she posted adversarial reviews on several online review sites about her dissatisfaction with a nose job. The patient, who remains unidentified, alleges that Guyuron acted in an untrustworthy and unprofessional manner, that she received no follow-up care, and that Guyuron urges people to post erroneous positive reviews online. She also claims that there was no informed consent to the procedure and that her nose is now twice as large as before.

Guyuron is seeking monetary damages, an injunction against the patient to prevent her from posting negative reviews about him online, and an order to remove all existing statements about him from the Internet.

Clinical Laboratories Vulnerable to Negative Reviews

Healthcare is complicated and positive outcomes can never be guaranteed. When patients do not get satisfaction by complaining to the doctors and facilities, they may seek other ways to be heard. And negative comments made on social media and online review websites can harm the reputations and businesses of physicians and medical facilities.

“It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people,” Lisa McGiffert, former head of the Consumer Reports Safe Patient Project, told USA Today. “This is what happens when your system of oversight is failing patients.”

However, Ryan Lorenz, Petta’s attorney warns consumers to be aware of the consequences of posting critical online reviews, especially if they post factually inaccurate information. “Make sure what you are saying is true—it has to be truthful,” he told USA Today.

Similar situations can arise in the clinical laboratory industry as well. There were multiple postings on Yelp in 2014 and 2015 by patients criticizing blood-testing company Theranos regarding discordant test results they’d received from Theranos’ lab, which Dark Daily covered in multiple e-briefings.

Trust is the hardest thing to earn, the easiest thing to lose, and once gone, can be impossible to get back. Clinical laboratories are just as susceptible to negative reviews as hospitals and doctors.

Worse yet, labs can be drawn into lawsuits simply because they service the hospital systems and caregivers involved. Preparing in advance for this possibility should be on every clinical laboratory manager’s do list.

—JP Schlingman

Related Information:

Doctors, Hospitals Sue Patients Who Post Negative Comments, Reviews on Social Media

Doctor Sues Patient for $1 Million for Posting Negative Reviews Online

I Wrote a Negative Yelp Review—and it Made My Life a Nightmare

Hospital Sues Over Facebook Post and Picketing

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

Federal Appeals Court Rules Yelp Not Responsible for Bad Reviews; Labs Advised to Examine Their Online Presence

Online Negative Reviews Can Threaten Clinical Laboratories Not Prepared to Address Feedback or Manage Their Internet Presence

Online Negative Reviews Can Threaten Clinical Laboratories Not Prepared to Address Feedback or Manage Their Internet Presence

As consumers increasingly choose physicians and service providers based on other people’s feedback on review websites, Internet-based customer service programs are becoming critical business tools for clinical laboratories and pathology groups

Clinical laboratory managers are becoming increasingly aware that negative reviews on anonymous online review sites, such as Yelp and others, can negatively impact revenues.

Official sources and surveys, such as Medicare’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), already provide information and ratings on healthcare service providers. However, recent coverage in Healthcare Dive highlights how consumers are finding the narrative reviews on websites such as Yelp more accessible and relatable. And, that these reviews focus on the criteria consumers find most important.

“We’re moving to a health system where patient ratings are becoming more important, [one] where top-down ratings are really inaccessible to patients and probably not that useful,” Yevgeniy Feyman, PhD, told Healthcare Dive. Feyman, along with Paul Howard, PhD, co-authored the Manhattan Institute report, “Yelp for Health.”

In the report, they examined the correlation between Yelp reviews of New York hospitals and objective measures of hospital quality. “We find that higher Yelp ratings are correlated with better-quality hospitals and that they provide a useful, clear, and reliable tool for comparing the quality of different facilities as measured by potentially preventable readmission rates (PPR), a widely accepted metric,” they stated.

This is a significant finding for clinical laboratory administrators and pathologists. It demonstrates that how patients review their provider experiences does align with objective measures of provider quality that may be public, but are not as easy for consumers to find as websites like Yelp, Healthgrades, and others.

Online Reviews: A Metric for Determining Healthcare Value and Quality?

Andrea Ducas, Senior Program Manager with the Robert Wood Johnson Foundation (RWJF), told Healthcare Dive the primary considerations patients use to pick providers include:

  • “Treats patients with respect;
  • “Accepts insurance;
  • “Shares in decision-making;
  • “Responsiveness to phone calls; and,
  • “Professional skill.”

Research into how patients find/choose their physicians conducted by OnePoll and commissioned by Binary Fountain determined that, of more than 1,000 adults surveyed:

  • “95% of respondents regard online ratings and reviews as ‘somewhat’ to ‘very’ reliable;
  • “75% of Americans say online ratings and review sites have influenced their decision when choosing a physician; and,
  • “30% of consumers share their own healthcare experiences via social media and online ratings and review sites.”

Common research sources listed by respondents included:

Can Online Reviews Damage Healthcare Providers?

“Given that the majority of quality measures out there … aren’t really that accessible for patients, this is a very good proxy,” Feyman told U.S. News in a report on physicians’ concerns about the use and popularity of review sites.

“[T]he emphasis placed on a small number of patient opinions—far fewer patients leave reviews than are treated in a typical health system—makes it harder for doctors to do their job for fear of a career-harming bad review. And a few negative posts from disgruntled patients could unfairly skew public perception—and eventually, a provider’s bottom line,” U.S. News noted.

Despite this, Luther Lowe, Yelp’s Senior Vice President of Public Policy and Government Affairs, assured Healthcare Dive they have processes to “filter spam and quell suspicious activity daily.”

Online reviews recently played an important role in the Wall Street Journal (WSJ) exposé on Theranos, which Dark Daily covered in 2016. Investigative reporter John Carreyrou (above) used Yelp to locate patients who reported negative experiences with specific healthcare services and practices. He described how he used the platform during a presentation to the Association of Health Care Journalists (AHCJ) in April 2018. Click on this link to watch a video of Carreyrou’s presentation. (Photo copyright: Association of Healthcare Journalists.)

Negative Reviews: A Critical Concern for Medical Laboratories

Consumers continue to use Internet platforms to both share ratings and compare information on healthcare professionals and the clinical laboratories supporting them. Thus, to prevent damage from negative reviews, labs must actively monitor feedback, pursue inaccurate information posted online, and encourage consumers to provide positive feedback and opinions.

According to data from Alexa, Yelp is the 32nd most visited website in the United States. Yelp’s own data reports that more than 150-million reviews have been added to the site since its inception 13 years ago.

And, Yelp categorizes 7% of the reviewed businesses as “health-related.”

Between easy-to-access information distributed online and an increased push for transparency, clinical laboratories and other healthcare service providers must work to take charge of the narrative created about their businesses and encourage positive feedback on these developing platforms.

Failing to do so could cost laboratories the physicians’ practices they service.

“There are some providers who are trying to get ahead of the curve and post reviews directly on their website,” Ducas told Healthcare Dive. “Another thing they can do is encourage their patients to read some reviews online and invite them to leave feedback. That’s a radical invitation but it’s certainly something they can do.”

As healthcare customers increasingly turn to review sites for feedback about healthcare facilities and the service providers supporting them, clinical laboratories and anatomic pathology groups must focus on their Internet presence and respond quickly to any negative review feedback with great customer service.

—Jon Stone

Related Information:

Providers Jittery over ‘Yelpification’ of Healthcare

Highlights from the Healthcare Consumer Insight and Digital Engagement Survey

Yelp Proving to Be Reliable for Hospital Reviews, Addresses 12 More Measures than HCAHPS Scores

Using Yelp for Your Health

Most Top Hospital Online Reviews Are Lukewarm or Negative

Hospitals That Receive Top Marks in Quality Rankings Earn Mediocre Reviews Online, Analysis Finds

Study: Nearly 63% of Yelp Reviewers Give Top-Ranked Hospitals Mediocre to Poor Ratings

Study Suggests Yelp Can Help People Find Quality Healthcare

Yelp for Health: Using the Wisdom of Crowds to Find High-Quality Hospitals

Federal Appeals Court Rules Yelp Not Responsible for Bad Reviews; Labs Advised to Examine Their Online Presence

Direct-to-Consumer Clinical Laboratory Test Developer, EverlyWell, Receives $1 Million in Funding from Shark Tank Investor

Direct-to-consumer medical laboratory testing company gets a major shot in the arm as developers find ready investors and increasing consumer demand

Clinical laboratory tests, usually performed without fanfare, were thrust into the limelight during a recent episode of Shark Tank, an American reality TV show on which aspiring entrepreneurs compete for the attention and partnership funds of various investors.

EverlyWell, a direct-to-consumer (DTC) company that offers at-home lab tests without lab visits or doctor referrals, obtained a $1-million line of credit from Lori Greiner, one of Shark Tank’s participating entrepreneurs, according to MobiHealthNews. EverlyWell has consumers collect their own specimens at home, which are then sent to a medical laboratory testing facility.

Based in Austin, Texas, EverlyWell was founded in 2015 by Julia Taylor Cheek, CEO, with an aim to “make lab tests accessible, simple, and meaningful,” according to a news release. Cheek is also a Venture Partner with NextGen Venture Partners and formerly the Director of Strategy and Operations with the George W. Bush Institute.

“It’s incredible for the industry that we were selected and aired on a show like Shark Tank. It really shows the intersection of what’s happening in consumer healthcare and the high cost in healthcare and that people are really responding to new solutions,” Cheek told MobiHealthNews.

“I think the product is brilliantly crafted,” Greiner stated during the episode’s taping, according to MobiHealthNews. “It’s really nice; it’s really easy. It’s super clear. I think the state of healthcare in our country now is so precarious. I think this gives people an empowered way … to know whether or not they have to go find a doctor,” she concluded.

Greiner offered the $1 million line of credit (with 8% interest) in exchange for a 5% equity stake in EverlyWell, explained Austin360. According to SiliconHillsNews, she did so after reviewing certain EverlyWell financial indicators, including:

  • $2.5 million in revenue in 2016;
  • $5 million expected revenue in 2017; and
  • 20% monthly growth rate.

Julia Cheek, CEO and Founder of EverlyWell (above), in a news release following her success on reality show Shark Tank, said, “We’re leading a major shift in the consumer health marketplace by bringing the lab to consumers’ doorsteps, and we are moving quickly to expand our channels, launch innovative tests, and deliver a world-class customer experience.” (Photo copyright: Forbes/Whitney Martin.)

Physician Review Still Part of Home-testing Process

EverlyWell lists 22 home lab tests on its website and a market share that encompasses 46 states. Shoppers can search for specific tests based on symptoms or by test categories that include:

  • General Wellness;
  • Men’s Health;
  • Women’s Health;
  • Energy and Weight; and
  • Genomic Test (through a partnership with Helix, a personal genomics company).

The most popular test panels include:

  • Food sensitivity;
  • Thyroid;
  • Metabolism;
  • Vitamin D; and,
  • Inflammation.

Prices range from $59 for a glycated hemoglobin (HbA1c) test (found under the general wellness category) to $399 for a women’s health testing kit. EverlyWell explains that it has no insurance contracts for these diagnostic tests, which do not require office or lab visits.

The testing process, according to EverlyWell’s website, proceeds as follows:

  • After ordering and paying online, kits arrive at the customer’s home;
  • The consumer self-collects a sample (such as blood spots, dried urine, or saliva) and returns it by prepaid mail to a medical laboratory that partners with EverlyWell. The company notes that it works with CLIA (Clinical Laboratory Improvement Amendment)-certified laboratories;
  • A board-certified doctor reviews the lab results; and,
  • A report is available online in a few days.

“Our goal is not to remove the importance of physician review. It’s to make the experience easier for the consumer,” Cheek told Texas CEO Magazine. “We designed a platform that is all about access and empowering consumers to have access to and monitor their own health information,” she continued.

Texas CEO Magazine explained that Cheek was inspired to create the company following “a bad personal experience with health and wellness testing that sent her to seven different specialists, cost $2,000 out of pocket, and left her with pages of unreadable results.”

Since then, the three-year old start-up company has garnered more than $5 million in venture capital, noted the news release.

Many Choices in Direct-to-Consumer Lab Company Market

EverlyWell is not the only player in the DTC clinical laboratory test space. According to MedCityNews, there are at least 20 other DTC lab test companies in the market including:

  • 23andMe;
  • Laboratory Corporation of America (LabCorp);
  • Mapmygenome;
  • Pathway Genomics;
  • Quest Diagnostics (Quest);
  • Sonora Quest Labs;
  • Theranos; and others.

The direct-to-consumer lab test market grew from $15 million to about $150 million in 2015 and includes both large and small clinical laboratory test developers, noted Kalorama Information.

Clearly, the DTC testing market is expanding and garnering the attention of major developers and investors alike. This growing demand for home-testing diagnostics could impact anatomic pathology groups and smaller clinical laboratories in the form of reduced order testing and decreased revenue.

—Donna Marie Pocius

Related Information:

Mail-Order Lab Test Startup EverlyWell Makes Million Dollar Deal on ABC’s Shark Tank

EverlyWell Raises Additional Capital, Bringing Total to $5 Million

This Austin Entrepreneur Scored Historic Deal on Shark Tank

Austin-based EverlyWell Lands Deal on Shark Tank

Innovative Texas Businesses: Empowering Consumers; Julia Cheek’s EverlyWell’s Health and Wellness Testing

Meet the Start-up Revolutionizing the Lab Testing Industry

20 Key Payers in the Direct-to-Consumer Lab Testing Market

Direct-to-Consumer Services Put Down Roots in US Lab Testing Market

Clinical Pathology Laboratories Should Expect More Direct-to-Consumer Testing

Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private

Real-time In Vitro Diagnostic Results at the Point of Care? Possible? One San Diego-based IVD Developer Says “Yes!”

Genalyte’s cloud-based Maverick Detection System could potentially change how and when doctors order blood draws, altering long-standing clinical laboratory workflows

Anatomic pathologists and medical laboratory leaders may be aware of efforts in the in vitro diagnostics (IVD) industry to perform clinical laboratory tests with smaller quantities of blood. The most high-profile company to try and fail is Theranos, which both Dark Daily and its sister print publication The Dark Report reported on as events unfolded.

So far, though, continued efforts to dramatically reduce the amount of blood needed for most typical medical laboratory tests have come up dry. But this has not stopped innovative companies from trying to do so.

One such company is San Diego-based Genalyte. The biomedical diagnostics developer has announced it is readying its new Maverick Detection System (Maverick), which, according to the company’s website, “completes a comprehensive battery of blood tests in the physician’s office with results in 15 minutes.”

According to a news release, “Genalyte is laying the groundwork to move the business of biomedical diagnostics online, with the idea of creating an integrated delivery service for test results that can be generated from a drop of blood.” If successful, Maverick may be poised to disrupt the phlebotomy and clinical laboratory industries in a big way.

Fifteen Minutes from Fingerprick to Clinical Lab Test Results

Maverick, according to its developers, “[will] send digital samples to the cloud for quality review before releasing to the physician and patient. Our central lab handles tests that cannot be completed onsite.

“At the core of our cloud-based, diagnostic laboratory offering is revolutionary technology that uses silicon photonic biosensors to perform multiple tests off a single drop of whole blood in 15 minutes,” notes Genalyte’s website.

In a MedCity News article, Cary Gunn, Genalyte’s founder and CEO, said, “There will always be a need for esoteric testing that needs to be referred to a laboratory. But for the vast majority of routine testing, there’s no reason why that can’t be done in the doctor’s office.”

How Maverick Completes Medical Laboratory Tests in Doctor’s Offices

According to Genalyte’s website, “The Maverick Detection System performs real-time detection of macromolecules in crude samples using biologically functionalized silicon photonic biosensors lithographically printed on disposable silicon chips.”

About the width of a pencil erasure, Maverick biosensor chips “are individually functionalized with unique probe molecules and are individually interrogated, making highly multiplexed analysis possible. As a sample flows over the chip, the probes on the sensors bind with their corresponding ligands. This binding results in a localized change in refractive index on the sensor surface; this change is directly proportional to analyte concentration.”

“The silicon chip itself is watching the chemical reactions take place. Anytime two molecules bind, we can see that happen. So, the technology is capable of almost an infinite number of tests,” Gunn explained in the MedCity News article.

According to the developer, test results are available “in 10-30 minutes depending on the type of assay performed.”

Cary Gunn PhD

Cary Gunn, PhD, Genalyte’s Founder and Chief Executive Officer, said in a news release that the San Diego-based biomedical diagnostics company wants “to put a rapid and powerful suite of diagnostic tests in every physician’s office.” (Photo copyright: Genalyte.)

Pilot Studies Show Test Feasibility in Doctor’s Offices

The company also announced completion of two pilot studies of the platform’s effectiveness in performing anti-nuclear antibody (ANA) testing. The purpose of study “one” was to “evaluate the feasibility of using this novel instrument to perform ANA 8 tests in the clinic and to compare those results to the same sample tested in Genalyte’s CLIA registered laboratory.” Study “two” focused on “Detection of anti-nuclear antibodies for the diagnosis of connective tissue diseases (CTD).”

The ANA test is often ordered by physicians for diagnosis of CTDs, including:

• Rheumatoid arthritis;

Systemic lupus erythematosus;

•  Raynaud syndrome; and,

Systemic scleroderma, according to an article in Rheumatoid Arthritis News.

“We are starting with rheumatology, but I call that our entry point,” Gunn told MedCity News. “Our goal is to decentralize the vast majority of diagnostic testing to be near the patient and near the physician.”

The two studies together involved about 750 patients, who were tested by Genaltye’s Maverick system over four months. Results of their blood tests, via fingerprick in the doctor’s office, were compared to traditional medical laboratory procedures and patient diagnoses.

How Maverick Technology Works video

According to the Genalyte video above, “The Maverick Detection System … directly detects the binding of proteins or antibodies to the sensor in real-time and results are analyzed simultaneously with the accompanying Genalyte software. Almost all of the most time consuming and expensive parts of assay development and sample testing are reduced or eliminated.” Click on the image to view the video. (Caption and video copyright: Genalyte.)

According to the news release and the published clinical abstracts, the researchers concluded that:

• Positive and negative results on whole blood tested on the Maverick system highly correlated with serum tested on previously approved devices;

• Multiplex ANA testing on whole blood in physician offices is feasible;

• Venous draw and fingerstick blood samples highly correlated; and

• Maverick has the propensity to improve patients wait times for diagnosis and to enhance their testing convenience.

“There is extremely high correlation for absolute value between venous blood and fingerstick blood, and between positive and negative results seen with whole blood on the Maverick and serum on the FIDIS Connective 10,” noted study “one” researchers.

“I’m impressed,” Patricia Jones, PhD, former President of the American Association for Clinical Chemistry (AACC), told Bloomberg News. “The game-changing part of this would be being able to do testing and potentially make a diagnosis immediately, instead of having to send out lab tests, wait several days, and then call the patient,” she added.

Can One Drop Do It All? Some Researchers Advise Caution

The controversy surrounding point-of-care fingerprick capillary blood draws performed on in-office automated blood analyzers, versus clinical laboratory venous draws performed on high-volume laboratory systems, is not new. Dark Daily has reported on several blood test studies in the past.

One such study involved bioengineers at Rice University. It concluded that fingerpricked capillary blood may not be accurate or reliable enough for clinical decision-making.

Their study acknowledged the value of such capillary blood testing in remote areas. But it also urged caution about use of measurements from a single drop of fingerprick blood.

“Using both a hematology analyzer and POC hemoglobinometer, we found the variability of blood component measures to be greater for successive drops of fingerprick blood than for multiple drops of venous blood,” the researchers wrote in The American Journal of Clinical Pathology (AJCP).

Research will no doubt continue until a viable, accurate, and affordable blood analyzer system that conducts dozens of clinical laboratory tests based on a few drops of blood comes to market. It’s basically inevitable in today’s world where computers can be built from molecules and miniature medical laboratories can be placed in chips, skin patches, and needles.

Pathologists and clinical laboratory leaders would be well advised to monitor the development of these various new diagnostic technologies. For most of the past decade, there has been a steady parade of companies and research teams announcing new discoveries that could revolutionize clinical diagnostics as performed today. However, few disruptive clinical laboratory tests or analyzers based on these technologies have made it into the clinical marketplace.

—Donna Marie Pocius

Related Information:

Can Genalyte Achieve What Theranos Touted?

Genalyte Takes Aim at Lab Testing Giants with Cloud-Based Service

Genalyte Raises $36 Million From Khosla for its One-Drop Blood Test

AACC President Calls Genalyte’s Blood Diagnostic Tests ‘Game-Changing’

Drop-to-Drop Variation in the Cellular Components of Fingerprick Blood: Implications for Point-of-Care Diagnostic Development

Genalyte Diagnostic Tool Shows Potential to Improve Turnaround Time in RA, Other Conditions

Application of a Novel Anti-Nuclear Antibody Multiplex Test Using Finger Stick and Venous Whole Blood in a Rheumatology Clinic—Demonstration of Feasibility

Rice University Researchers Publish Study About Variation in Drop-to-Drop Samples of Capillary Blood Collected by Fingerprick and Used for Clinical Laboratory Testing

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Score for Theranos After AACC: Fail

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