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Amazon Expands Its Virtual Primary Care Service, including Clinical Laboratory Testing, to All 50 States along with More Locations for One Medical Clinics

Consumer demand for telehealth services and convenient healthcare locations fuels Amazon’s quest to ‘reinvent’ healthcare

Amazon’s stated goal of disrupting traditional healthcare processes and workflow continues. During the COVID-19 pandemic, Amazon built several large clinical laboratories to do its own SARS-CoV-2 testing. Then, last February, Amazon acquired One Medical, a San Francisco-based primary care provider that offers telehealth services, for $3.9 billion. Now, Amazon is opening new One Medical locations and expanding its primary care service nationwide.  

Dark Daily covered Amazon’s 2022 announcement to purchase One Medical in “Amazon Signs Agreement to Purchase One Medical for $3.9 Billion, Aims to ‘Reinvent’ Healthcare.” We reported how, for years, Amazon has tried to develop medical services that disrupt the US healthcare industry in the same way its digital book business upended traditional book publishing.

Acquiring One Medical gave Amazon dozens of existing physical healthcare locations. There are currently more than 125 One Medical clinics offering clinical laboratory testing and primary care services—including telehealth and live chat consulting—in several large metropolitan areas around the country.

For an annual fee of $199, patients who utilize One Medical receive access to year around 24/7 on-demand, virtual care. Other services, such as in-office doctor visits and clinical laboratory testing, can be billed to most major insurance health plans.

The trend of shifting clinical services from in-person, medical-office visits to other approaches, such as virtual care, continues to expand throughout the healthcare industry driven by consumer demand.

Amazon now offers virtual healthcare services in all 50 states and the District of Columbia. The company appears committed to delivering what it believes are better alternatives to existing primary care, clinical laboratory, and retail pharmacies.

“We’re on a mission to make it dramatically easier for people to find, choose, afford, and engage with the services, products, and professionals they need to get and stay healthy, and coming together with One Medical is a big step on that journey,” said Neil Lindsay, Senior Vice President of Amazon Health Services in a press release. Clinical laboratories in areas where One Medical operates may want to investigate opportunities to collaborate with Amazon. (Photo copyright: Advertising Age/Daniel Berman.)

Does One Medical Represent the Future of Healthcare?

In August, Amazon announced the opening of new One Medical offices in Connecticut and San Francisco. A new facility will also be opened in Milwaukee in the fall with more new locations planned for 2024. 

“If you fast forward 10 years from now, people are not going to believe how primary care was administered. For decades, you called your doctor, made an appointment three or four weeks out, drove 15-20 minutes to the doctor, parked your car, signed in and waited several minutes in reception, eventually [you] were placed in an exam room, where you waited another 10-15 minutes before the doctor came in, saw you for five to ten minutes and prescribed medicine, and then you drove 20 minutes to the pharmacy to pick it up—and that’s if you didn’t have to then go see a specialist for additional evaluation, where the process repeated and could take even longer for an appointment,” said Amazon CEO Andy Jassy in a One Medical news release.

“Customers want and deserve better, and that’s what One Medical has been working and innovating on for more than a decade. Together, we believe we can make the healthcare experience easier, faster, more personal, and more convenient for everyone,” he added.

These are some of One Medical’s offerings according to the news release:

  • Around-the-clock access through the One Medical app.
  • On-demand virtual care services, like 24/7 video chats and easy in-app messaging, included in membership at no extra cost.
  • Same and next-day in-office or remote visits.
  • Walk-in availability for on-site clinical laboratory services.
  • Clinical and digital integrations with leading hospital networks across the US.
  • Easy access to vaccine and medical records, prescription renewals, specialty referrals, and lab results in the One Medical app.

“One Medical has set the bar for what a quality, convenient, and affordable primary care experience should be like,” said Neil Lindsay, Senior Vice President of Amazon Health Services in the news release. “We’re inspired by their human-centered, technology-forward approach and excited to help them continue to grow and serve more patients.”

Not Amazon’s First Attempt at Delivering Healthcare

This latest venture is not Amazon’s first dive into the healthcare market. The company initially began offering medical services through its Amazon Clinic in limited locations starting last November. 

According to its website, Amazon Clinic can quickly treat common health issues via 24/7 video visits with a clinician. No appointments are needed, and health insurance is not a requirement.

Other Amazon ventures into healthcare have not been successful. In 2020, their Haven Healthcare project failed less than three years after its launch. Despite partnering with Berkshire Hathaway and JPMorgan Chase, Haven Healthcare faltered mostly due to insufficient market power, unacceptable incentives, and poor timing because of the COVID-19 pandemic, according to Harvard Business Review.

Amazon also shuttered Amazon Care, a pilot program for their employees that blended telehealth and primary healthcare services, at the end of last year. 

With an increase in the number of companies moving into the healthcare market, patients may have access to better options, more reasonable pricing, and faster and more convenient access to services in the future, including clinical laboratory testing.

“At the end of the day, all patients, all customers, all people want to be healthy,” said Nworah Ayogu, MD, Amazon Clinic General Manager and founding Medical Director for CityBlock Health, during a CNBC Healthy Returns Summit virtual event earlier this year. “The reason why they’re not healthy is because the health system has all these barriers, so whether that is cost, confusion … some are societal, some within the healthcare system, so that’s really on us to remove those barriers and think through how we do that.”

Clinical laboratories operating in areas serviced by Amazon’s One Medical clinics may find an opportunity to help support Amazon’s goal of providing affordable healthcare in convenient locations. At the same time, pathologists and lab executives may find it timely to recognize how primary care is poised to be transformed by disruptors, such as Amazon and those national retail pharmacy chains now building primary clinics in their stores.

—JP Schlingman

Related Information:

Amazon Clinic Expands Doctor Visit Marketplace to 50 States

Amazon-owned One Medical Begins Opening New Locations Across US

Amazon-Owned One Medical Celebrates Grand Opening in Darien

Primary Care Designed Around You

One Medical Joins Amazon to Make It Easier for People to Get and Stay Healthier

Amazon Clinic Dr. Nworah Ayogu at CNBC Healthy Returns Summit 2023

Why Haven Healthcare Failed

Amazon, Berkshire Hathaway, and JPMorgan Chase Close Haven Healthcare After Only Three Years in Operation

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

Teladoc Reports $13.7B Loss for 2022, Just Two Years after Livongo Acquisition

Loss could indicate an industrywide slowdown in digital health adoption and suggests medical laboratories will want to continue developing a virtual care strategy

Only two years after Teladoc Health (NYSE:TDOC) completed acquisition of Livongo, a data-based health coaching company, the virtual healthcare provider reported a 2022 net loss of $13.7 billion, a company press release announced.

The loss, which has been described as “historic,” is “mostly from a write-off related to the plummeting value of its Livongo acquisition. … By comparison, in 2021 [just a year earlier], Teladoc posted a net loss of $429 million,” Fierce Healthcare reported.

However, during Teladoc’s fourth quarter earnings call, CEO Jason Gorevic said, “We are pleased with the strong fourth quarter and full-year operating results. Despite a challenging macro environment, we were able to expand our product offerings and enhance the level of care delivered across our integrated whole-person platform.” Teladoc Health’s 2022 revenue was $2,406,840 compared to $2,032,707 in 2021. That’s an 18% increase over last year’s revenue, according to the earnings report. Nevertheless, a month before the earnings call Teladoc laid off 300 non-clinician employees, Fierce Healthcare noted.

Jason Gorevic

“Teladoc Health has been at the forefront of the adoption curve, and we believe that our scale, breadth of product offering, and proven outcomes will enable us to maintain and expand our position in the market,” said Teladoc Health CEO Jason Gorevic during February’s earnings call. Clinical laboratory leaders may view the company’s $13B loss as indication that adoption in telehealth by physicians, healthcare providers, and patients of digital-based health services is not happening as swiftly has been predicted. (Photo copyright: The Business Journals.) 

Predictions in Telehealth Adoption Fall Short

Teladoc Health, based in Purchase, New York, acquired Livongo of Mountain View, California, in October 2020 for $18.5 billion. 

A news release at that time declared that the merger was “a transformational opportunity to improve the delivery, access, and experience of healthcare for consumers around the world.

“The highly complementary organizations,” the release stated, “will combine to create substantial value across the healthcare ecosystem, enabling clients everywhere to offer high quality, personalized, technology-enabled longitudinal care that improves outcomes and lowers costs across the full spectrum of health.”

The deal was hailed as advancing telemedicine and digital health services. As it turned out, though, the demand for those types of services fell far short of the Teladoc’s expectations. One way to interpret the cause of the multi-billion dollar write-down is that adoption of digital health services by physicians, healthcare providers, and consumers is not happening as fast as Teladoc projected.

It may also be that companies allocated too much money to deals during the COVID-19 pandemic, an unstable period of time for making major business decisions.

In fact, worldwide digital health funding fell 57% in 2022 after a high in 2021, according to a CB Insights State of Digital Health 2022 Report.

Teladoc to Reduce Costs while Pursuing Increased Adoption of Virtual Care

Gorevic told analysts during the earnings call that the company needs to reduce costs and reach a market that is “in the early innings.” Year-over-year growth of 6% to 11% is expected in 2023, he said.

“You should expect us to balance growth and margin with an increased focus on efficiency going forward. Part of that approach is rightsizing the cost structure to reflect the current growth rates of the business,” Gorevic said. “The more balanced approach does not mean that we will stop relentlessly pursing growth and increased adoption of virtual care across the industry. Virtual care’s role within the healthcare industry remains underpenetrated, and we will continue to invest to expand our leadership position,” he added.

Digital Health Investing Falls Off

However, citing digital health market data in the new CB Insights report, Becker’s Hospital Review(Becker’s) suggested the digital health bubble may have “popped,” and that funding by investors is falling fast from the “Golden Age” of 2021.  

The digital health category grew by 79% in 2021 to $57.2 billion, a record high, according to data cited by Becker’s. In the fourth quarter of 2021, there were 13 new digital health companies with valuations of at least $1 billion each. But by the end of 2022, digital health funding dropped to $3.4 billion. That’s “a five-year low,” Becker’s reported.

“The drop in funding in digital health companies I feel is a response to the volatility in healthcare where over 50% of hospitals and healthcare providers have posted losses for 2022 and a bleak outlook for 2023,” Darrell Bodnar, Chief Information Officer at North Country Healthcare in Lancaster, New Hampshire, told Becker’s.

And, in a statement about hospitals’ financial health, Fitch Ratings said providers in 2022 reported “weaker profitability and liquidity” as compared to 2021. For most providers, a “rapid financial recovery” is not expected, Fitch noted.

Labs Need Telehealth Strategies

All of this uncertainty in the telehealth/virtual care markets may ultimately benefit clinical laboratories and lab investors who delayed investing in technology that enables supporting physicians and patients using telemedicine visits. Still, it would be smart for medical laboratory leaders to develop a digital health strategy to meet consumer demand for lab testing services in tandem with virtual care visits with healthcare providers. 

—Donna Marie Pocius

Related Information:

Teladoc Health Reports Fourth Quarter and Full Year 2022 Results

Teladoc Sinks $13.7B Loss in 2022 Tied to Plummeting Value of Livongo Acquisition

Teladoc Health and Livongo Merge to Create New Standard in Global Healthcare Delivery, Access, and Experience

State of Digital Health 2022 Report

What is Digital Health?

Teladoc Health Reports $13B Loss in 2022

Early Not-for-Profit Hospital Medians Show Expected Deterioration, Will Worsen

Did the Digital Health Bubble Pop? CIOs Weight In

Clarapath Acquires Crosscope, Bridging Histology Automation with Digital Pathology

Clarapath is working to automate manual processes in histology while also capturing data to better inform clinical laboratories

Looking to provide an end-to-end digital pathology solution, medical robotics maker Clarapath has acquired Crosscope, a medical artificial intelligence (AI) software company that develops AI-powered telepathology for medical image information extraction and precision medicine diagnostics.

The deal will enable Crosscope’s digital pathology platform to layer around Clarapath’s histology automation hardware, a combination that could improve quality and efficiencies in diagnostic services for future customers, according to a Clarapath press release.

Clarapath’s goal with its products is to automate certain manual processes in histology laboratories, while at the same time reducing variability in how specimens are processed and produced into glass slides. In an exclusive interview with Dark Daily, Eric Feinstein, CEO and President at Clarapath said he believes the resulting data about these activities can drive further changes.

“A histotechnologist turns a microtome wheel and makes decisions about a piece of tissue in real time,” noted Feinstein, who will speak at the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management on April 25-26 in New Orleans. “All of that real-time data isn’t captured. Imagine if we could take all of that data from thousands of histotechnologists who are cutting every day and aggregate it. Then you could start drawing definitive conclusions about best practices.”

Eric Feinstein

“Clarapath’s foundation is about creating consistency and standardizing steps in histology—and uncovering the data that you need in order to accomplish those goals as a whole system,” Eric Feinstein (above), CEO and President at Clarapath told Dark Daily. “A histology lab’s workflow—from when the tissue comes in to when the glass slide is produced—should all be connected.” Many processes in histology and anatomic pathology continue to be manual. Automated solutions can contribute to improved productivity and reducing variability in how individual specimens are processed. (Photo copyright: Clarapath.)

Details Behind Clarapath’s Deal to Acquire Crosscope

As part of its acquisition, Clarapath of Hawthorne, New York, has retained all of Crosscope’s employees, who are located in Mountain View, California, and Bombay, India. Financial terms of the deal were not disclosed.

Clarapath’s flagship histology automation product is SectionStar, a tissue sectioning and transfer system designed to automate inefficient and manual activities in slide processing. The device offers faster and more efficient sample processing while reducing human involvement. Clarapath expects SectionStar be on the market in 2023. The company is currently taking pre-orders. 

Meanwhile, Crosscope developed Crosscope Dx, a turnkey digital pathology solution that provides workflow tools and slide management as well as AI and machine learning to assist pathologists with their medical decision-making and diagnoses.

Adoption of Digital Pathology and Automation Can Be Challenging

Digital pathology has experienced growing popularity in the post-COVID-19 pandemic world. This is not only because remote pathology case reviews have become increasingly acceptable to physicians but also because of the ongoing shortages in clinical laboratory staffing.

“A pain point today for clinicians and laboratories is labor. That’s across the board,” Feinstein said. “We can help solve that with SectionStar.”

In “Recent Separate Business Transactions by Fujifilm and GE Healthcare Suggest Bullish Outlook for Faster Adoption of Digital Pathology,” Dark Daily reported that vendors have their eyes open for deals and partnerships in digital pathology.

Feinstein does not believe adoption of digital pathology and histology automation is proceeding slowly, but he does acknowledge barriers to healthcare organizations installing the technologies.

“There are lots of little things that—from a workflow perspective—people have outsized expectations about,” he explained. “Clinicians and administrators are not used to innovating in a product sense. They may be innovating on how they deliver care or treatment pathways, but they’re not used to developing an engineering product and going through alpha and beta stages. That makes adopting new technology challenging.”

Medical laboratory managers and pathologists interested in pursuing histology automation and digital pathology should first determine what processes are sub-optimal or would benefit from the standardization hardware and software can offer. Being able to articulate those gains can help build the case for a return on investment to decision-makers.

Another resource to consider: Feinstein will speak about innovations for remote histology laboratory workers at the upcoming Executive War College for Clinical Laboratory, Diagnostics, and Pathology Management on April 25-26 in New Orleans. His session is titled, “Re-engineering the Classic Histology Laboratory: Enabling the Remote Histotechnologist with New Tools That Improve Productivity, Automate Processes, and Protect Quality.”

Scott Wallask

Related Information:

Clarapath Acquires Crosscope and Combines Tissue Processing Robotics with AI Powered Digital Pathology for Building the Lab of the Future

Histopathology is Ripe for Automation

UCLA’s Virtual Histology Could Eliminate Need for Invasive Biopsies for Some Skin Conditions and Cancers

2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management Announced for April 25-26

Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage

In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs).

But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate committees urging passage of legislation that would enable some regulation of LDTs, the VALID Act was ultimately omitted from the year-end omnibus spending bill (H.R. 2617).

That may be due to pressure from organizations representing clinical laboratories and pathologists which lobbied hard against the bill.

The American Association for Clinical Chemistry (AACC), American Society for Clinical Pathology (ASCP), Association for Molecular Pathology (AMP), Association for Pathology Informatics, and Association of Pathology Chairs were among many signatories on a May 22 letter to leaders of the US Senate Committee on Health, Education, Labor and Pensions that described the bill as “very flawed, problematic legislation.”

The Association of American Medical Colleges (AAMC) also signed the letter, as did numerous medical laboratories and health systems, as well as the American Society of Hematology and the Clinical Immunology Society.

Emily Volk, MD

Responding to criticism of its stance on FDA oversight of LDTs, in a May 2022 open letter posted on the organization’s website, anatomic pathologist and CAP president Emily Volk, MD, said “we at the CAP have an honest difference of opinion with some other respected laboratory organizations. … We believe the VALID Act is the only viable piece of legislation addressing the LDT issue. … the VALID Act contains many provisions that are similar to policy the CAP has advocated for regarding the regulation of laboratory tests since 2009. Importantly, the current version includes explicit protections for pathologists and our ability to practice medicine without infringement from the Food and Drug Administration (FDA).” (Photo copyright: College of American Pathologists.)

Organizations on Both Sides Brought Pressure to Bear on Legislators

“University laboratories and their representatives in Washington put on a full-court press against this,” Rep. Larry Bucshon, MD, (R-Indiana) told ProPublica. Bucshon, who is also a cardiothoracic surgeon, co-sponsored the VALID Act along with Rep. Diana DeGette (D-Colorado).

The AAMC and AMP were especially influential, Bucshon told ProPublica. In addition to spending hefty sums on lobbying, AMP urged its members to contact legislators directly and provided talking points, ProPublica reported.

“The academic medical centers and big medical centers are in every state,” Bucshon said. As major employers in many locales, they have “a pretty big voice,” he added.

CAP, on the other hand, was joined in its efforts by AdvaMed, a trade association for medical technology companies, the American Cancer Society Cancer Action Network, Association for Clinical Oncology (ASCO), Association of Black Cardiologists, Friends of Cancer Research, Heart Valve Voice US, LUNGevity Foundation, and The Pew Charitable Trusts.

Discussing CAP’s reasoning behind its support of the VALID Act in a May 26 open letter and podcast, CAP president Emily Volk, MD, said the Valid Act “creates a risk-based system of oversight utilizing three tiers—low, moderate and high risk—in order to target the attention of the FDA oversight.”

While acknowledging that it had room for improvement, she lauded the bill’s three-tier risk-based system, in which tests deemed to have the greatest risks would receive the highest level of scrutiny.

She also noted that the bill exempts existing LDTs from an FDA premarket review “unless there is a safety concern for patients.” It would also exempt “low-volume tests, modified tests, manual interpretation tests, and humanitarian tests,” she wrote.

In addition, the bill would “direct the FDA not to create regulations that are duplicative of regulation under CLIA,” she noted, and “would require the FDA to conduct public hearings on LDT oversight.”

Pros and Cons of the VALID Act

One concern raised by opponents relates to how the VALID Act addressed user fees paid by clinical laboratories to fund FDA compliance activities. But Volk wrote that any specific fees “would need to be approved by Congress in a future FDA user fee authorization bill after years of public input.”

During the May 2022 podcast, Volk also cast CAP’s support as a matter of recognizing political realities.

“We understand that support for FDA oversight of laboratory-developed tests or IVCTs is present on both sides of the aisle and in both houses of Congress,” she said. “In fact, it enjoys wide support among very influential patient advocacy groups.” These groups “are very sophisticated in their understanding of the issues with laboratory-developed tests, and they do have the ear of Congress. There are many in the laboratory community that believe the VALID Act goes too far, but I can tell you that many of these patient groups don’t believe it goes far enough and are actively pushing for even more restrictive paradigms.”

Also urging passage of the bill were former FDA commissioners Scott Gottlieb, MD, and Mark B. McClellan, MD, PhD. In a Dec. 5 opinion piece for STAT, they noted that “diagnostic technologies have undergone considerable advances in recent decades, owing to innovation in fields like genomics, proteomics, and data science.” However, they wrote, laws governing FDA oversight “have not kept pace,” placing the agency in a position of regulating tests based on where they are made—in a medical laboratory or by a manufacturer—instead of their “distinctive complexity or potential risks.”

In their May 22 letter, opponents of the legislation outlined broad areas of concern. They contended that it would create “an onerous and complex system that would radically alter the way that laboratory testing is regulated to the detriment of patient care.” And even though existing tests would be largely exempted from oversight, “the utility of these tests would diminish over time as the VALID Act puts overly restrictive constraints on how they can be modified.”

CLIA Regulation of LDTs also Under Scrutiny

The provision to avoid duplication with the Clinical Laboratory Improvement Amendments (CLIA) program—which currently has some regulatory oversight of LDTs and IVCTs—is “insufficient,” opponents added, “especially when other aspects of the legislation call for requirements and activities that lead to duplicative and unnecessary regulatory burden.”

Opponents to the VALID Act also argued that the definitions of high-, medium-, and low-risk test categories lacked clarity, stating that “the newly created definition of moderate risk appears to overlap with the definition of high risk.”

The opponents also took issue with the degree of discretion that the bill grants to the US Secretary of Health and Human Services. This will create “an unpredictable regulatory process and ambiguities in the significance of the policy,” they wrote, while urging the Senate committee to “narrow the discretion so that stakeholders may better evaluate and understand the implications of this legislation.”

Decades ago, clinical laboratory researchers were allowed to develop assays in tandem with clinicians that were intended to provide accurate diagnoses, earlier detection of disease, and help guide selection of therapies. Since the 1990s, however, an industry of investor-funded laboratory companies have brought proprietary LDTs to the national market. Many recognize that this falls outside the government’s original intent for encouragement of laboratory-developed tests to begin with.

—Stephen Beale

Related Information:

The Tests Are Vital. But Congress Decided That Regulation Is Not.

Message from the CAP President on the VALID Act

Better Lab Test Standards Can Ensure Precision Medicine Is Truly Precise

Healthcare Groups Urge Congress to Pass Diagnostic Testing Reform Before Year’s End

Califf: FDA May Use Rulemaking for Diagnostics Reform If VALID Isn’t Passed

Is FDA LDT Surveillance Set to Improve as VALID Act Heads to Resolution?

Congress Needs to Update FDA’s Ability to Regulate Diagnostic Tests, Cosmetics

FDA User Fee Reauthorization: Contextualizing the VALID Act

They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated “Wild West.”

InsideHealthPolicy: Pew, AdvaMed, Others Push for VALID as Clock Ticks on Government Funding

AdvaMed Leads Letter Urging Lawmakers to Support Bipartisan Diagnostics Reform

Amazon Signs Agreement to Purchase One Medical for $3.9 Billion, Aims to “Reinvent” Healthcare

Company also launches Amazon Clinic virtual healthcare services and announces it will terminate Amazon Care by end of year

Clinical laboratory leaders and pathologists may understandably struggle to keep abreast of Amazon’s moves in the healthcare space. For years, Amazon has tried to develop medical services that disrupt the US healthcare industry in the same way its digital book business upended traditional book publishing. It is clear that Amazon is heavily investing in healthcare ventures that deliver what it believes are better alternatives to existing primary care, clinical laboratory, and retail pharmacy options.

Now, the Seattle-based global e-commerce company has announced plans to acquire One Medical, a membership-based primary care organization, for $3.9 billion according to a news release.

Headquartered in San Francisco, One Medical has primary care offices in 12 major US markets and offers its members 24/7 virtual care, according to the company’s website.

Neil Lindsay

“We think healthcare is high on the list of experiences that need reinvention,” said Neil Lindsay (above), SVP of Amazon Health Services, in a news release announcing the planned acquisition of One Medical. “We love inventing to make what should be easy easier, and we want to be one of the companies that helps dramatically improve the healthcare experience over the next several years,” he added. However, clinical laboratory leaders have watched Amazon’s efforts to disrupt healthcare come and go. (Photo copyright: Advertising Age/Daniel Berman.)

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As One Medical Grows, Amazon Launches Virtual Care Clinic

“One Medical’s philosophy is rooted in quality care, patient-centered design, and a smart application of technology,” Greg Hayes, MD, District Medical Director for One Medical, Preston Center, Dallas, told Texas News.

For its part, One Medical, which currently has more than 125 clinic locations, sees opportunity to grow its services as part of Amazon (NASDAQ:AMZN). “Joining Amazon is a tremendous next step in innovating and expanding access to high-quality, high-value healthcare,” said Amir Dan Rubin, One Medical Chief Executive Officer, in a blog post.

One Medical (NASDAQ:ONEM) is the operating name for 1Life Healthcare, Inc., a chain of primary care clinics that has 815,000 members, a 14% increase over last year. According to a news release on the company’s third quarter 2022 financial results, its revenue was $261.4 million, up 73% over the same period last year. More than 8,000 companies and organizations work with One Medical, the company’s website notes.

Meanwhile, Amazon is also launching Amazon Clinic, a virtual health service “that delivers convenient, affordable care for common conditions” to people in 32 states, an Amazon news release states.

Amazon Clinic offers virtual care services for 20 common conditions including allergies, acne, migraines, and urinary tract infections. Patients complete a questionnaire through a message-based portal prior to meeting with clinicians.

Clinical laboratory managers and pathologists will want to note that Amazon Clinic will need medical laboratory testing performed to properly diagnose patients and determine the best treatments. Since Amazon Clinic will be a virtual care service, Amazon can be expected to explore such options as sending collection kits directly to individuals using the virtual care service, allowing them to collect needed samples that can be returned to traditional clinical laboratories for testing. Amazon’s existing courier and delivery service would make it easy for the internet giant to deliver either specimen collection kits or home-test kits to obtain the necessary diagnostic data.

Patients needing prescriptions can use the company’s online pharmacy Amazon Pharmacy, or other retail pharmacies, noted Becker’s Hospital Review.

“Amazon Pharmacy and One Medical (once the deal closes) are two key ways we’re working to make care more convenient and accessible. But we also know that sometimes you just need a quick interaction with a clinician for a common health concern. … That’s why today were also introducing Amazon Clinic, a message-based virtual care service,” Amazon said in its news release.

What’s Next for Amazon?

Separately, Amazon announced it will terminate Amazon Care at the end of 2022. Amazon Care is a virtual and in-home care service it launched in 2019.

In “Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing,” Dark Daily reported how Amazon was piloting Amazon Care as a benefit for its 53,000 Seattle-area employees and their families, and how it could indicate that the world’s largest online retailer was planning a move into the primary care space.

However, in a 2022 internal email, senior vice president of Amazon Health Services Neil Lindsay said Amazon Care wasn’t a sustainable, long-term solution for its enterprise customers, according to Fierce Healthcare.

“This decision wasn’t made lightly and only became clear after many months of careful consideration,” he said. “Although our enrolled members have loved many aspects of Amazon Care, it is not a complete enough offering for the large enterprise customers we have been targeting and wasn’t going to work long-term.”

Will Amazon Provide Clinical Laboratory Services?

Now that Amazon is set with primary care, pharmacy, and virtual health services, might it next explore medical laboratory testing or other diagnostics relationships?

In “Amazon Now Interested in Home Testing Services,” Dark Daily’s sister publication The Dark Report noted that actions Amazon took during the COVID-19 pandemic suggest it may be “serious about clinical laboratory services.”

The Dark Report was alluding to US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, which was to be performed at clinical laboratories “designated by STS Lab Holdco (a subsidiary of Amazon.com Services LLC) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests,” according to Healthcare Purchasing News.

However, on July 19, the FDA revoked its EUA of the Amazon test.

But this apparently has not slowed Amazon’s drive to gain a foothold in the primary care and virtual health services market. Therefore, clinical laboratory leaders should advance their outreach to healthcare providers who are caring for Amazon employees, customers, and soon patients, in new ways and offer their lab services.   

—Donna Marie Pocius

Related Information:

Amazon and One Medical Sign an Agreement for Amazon to Acquire One Medical

Amazon and One Medical Have Landed in Dallas

What is Amazon Clinic?

Amazon Care Shutting Down End of 2022

One Medical Announces Results for Third Quarter 2022

Update from One Medical on Agreement to be Acquired by Amazon

Amazon Clinic Makes Debut: Six Things to Know

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services that Include Clinical Laboratory Testing

Amazon Now Interested in Home Testing Services

Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 Receives FDA EUA

Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

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