The IVD industry’s consolidation surge continues unabated, as advances in AI-driven genomics and a flurry of private equity deals reshape the sector for a data-driven decade ahead.
The in vitro diagnostics (IVD) market is entering a new phase of transformation, defined by innovation at the technology level and consolidation at the corporate level, as strategic buyers and investors reshape the competitive landscape.
In the latest move, QIAGEN announced plans to acquire Parse Biosciences for up to $280 million, a deal that will expand QIAGEN’s Sample technologies into the rapidly growing single-cell sequencing market. The acquisition gives QIAGEN access to Parse’s Evercode technology and massive-scale datasets—critical assets as AI-driven drug discovery and predictive biology become central to life sciences. The move underscores QIAGEN’s bet that future diagnostic and therapeutic breakthroughs will hinge on scalable, data-rich technologies rather than traditional instrument-based models.
The Dark Report noted recently in its ranking of top IVD companies that Qiagen was #10, a jump of three spots up from its prior ranking.
Alex Rosenberg, PhD, CEO and co-founder of Parse Biosciences added, “As our team joins QIAGEN, we want to accelerate that mission and extend the reach of our technology to more customers around the world. QIAGEN’s strong commitment to Sample technologies and its global infrastructure make it an ideal partner for our next stage of growth.” (Photo credit: Parse Biosciences)
M&A Highlights
The QIAGEN–Parse deal follows months of high-profile M&A activity reshaping the diagnostics sector.
In October, Hologic agreed to an $18.3 billion buyout by Blackstone and TPG, marking one of the largest private equity transactions in healthcare this year. The move takes a top-15 IVD and imaging company private, reflecting both investor confidence in the steady revenues of women’s health diagnostics and a broader pattern of capital consolidation in the space. Analysts suggest that private equity firms are seeking predictable, cash-generating platforms while large corporations increasingly focus on growth through specialization or divestment.
That strategy is on display at Siemens Healthineers, which is reportedly exploring a $7 billion divestiture of its diagnostics division to firms including Blackstone, KKR, and CVC Capital Partners. Such a sale would streamline Siemens’ portfolio around imaging and oncology technologies, while potentially placing one of the world’s largest IVD suppliers under new ownership.
Taken together, these deals highlight a defining moment for the diagnostics industry. Major corporations are repositioning their portfolios around data, AI, and precision medicine, while investors are moving aggressively to capture value in an industry that proved its resilience during and after the pandemic.
For laboratory leaders, the implications are clear: consolidation is accelerating, supply chains and vendor relationships may shift, and innovation is increasingly concentrated among fewer, but more powerful, players.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
The bipartisan RESULTS Act, designed to overhaul Medicare’s payment system for clinical laboratory testing, is on hold amid the ongoing government shutdown. With cuts of up to 15% set to hit 800 common lab tests in 2026, laboratory leaders warn that the delay threatens patient access and lab stability nationwide.
Efforts to reform how Medicare pays for clinical laboratory testing have hit a standstill as the ongoing federal government shutdown freezes legislative progress on Capitol Hill, delaying long-awaited relief for labs facing steep payment cuts in 2026.
The bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act—introduced in September by Senators Raphael Warnock (D-GA) and Thom Tillis (R-NC)—was gaining momentum as a fix to long-standing problems in the Medicare Clinical Laboratory Fee Schedule (CLFS). But with Congress largely at a standstill, the bill and several other healthcare measures are now in limbo, leaving labs anxious about their financial outlook heading into next year.
At stake are payment reductions of up to 15% for more than 800 commonly ordered laboratory tests, scheduled to take effect on January 1, 2026. Laboratory organizations warn that without swift action, the cuts could destabilize the nation’s diagnostic infrastructure, threaten patient access, and further weaken community and hospital outreach laboratories already strained by workforce shortages and inflation.
Organizations Pen Letter
In a letter sent to congressional leaders on October 30, more than two dozen healthcare and laboratory organizations, including the American Clinical Laboratory Association (ACLA), the College of American Pathologists (CAP), the American Hospital Association (AHA), and the American Medical Association (AMA), urged Congress to pass the RESULTS Act to “protect patient access to clinical laboratory services.”
“Timely access to innovative clinical laboratory tests is critical to the prevention, early detection, therapy selection, and effective management of chronic and life-threatening diseases,” the coalition wrote. “Without action, around 800 laboratory tests will be subject to payment cuts of up to 15% on January 1, 2026, threatening patient access to routine and life-saving diagnostics.”
The letter highlights a decade-long problem stemming from the Protecting Access to Medicare Act (PAMA) of 2014. That law aimed to align Medicare reimbursement with private market rates but relied on limited data reporting—less than 1% of lab data nationwide—resulting in artificially low payment rates. In its first three years alone, PAMA implementation cut nearly $4 billion from the CLFS. Congress has since delayed those cuts five times, but advocates say temporary fixes are no longer sustainable.
“The time for permanent reform is now,” the coalition urged.
Shutdown Leaves Critical Medicare Lab Payment Fix Hanging in the Balance
The RESULTS Act seeks to overhaul the payment process to ensure rates reflect the full diversity of the laboratory market, including independent, hospital outreach, and physician office laboratories. It would reduce administrative burdens on both labs and the Centers for Medicare & Medicaid Services (CMS), cap annual payment reductions at 5% instead of 15%, and extend data reporting cycles to every four years. The bill would also empower CMS to work with an independent third party to collect more representative market data and make rates subject to administrative or judicial review.
Supporters say these reforms would promote innovation and stabilize Medicare reimbursement. Industry groups agree that without reform, continued cuts could push smaller community and regional labs, particularly those serving rural or underserved populations, to close their doors.
ACLA president Susan Van Meter underscored the importance of laboratories in guiding medical decisions. “Clinical laboratories deliver essential information that individuals need to better understand their own health status, while also serving as the backbone of our healthcare system, providing the results that inform 70% of medical decisions,” she said.
ACLA president Susan Van Meter noted, “As our industry continues to innovate and tailor healthcare solutions through personalized medicine, the RESULTS Act is a critical step to safeguard access to these life-saving tools, reinforce our healthcare infrastructure, and support continued innovation in laboratory medicine.” (Photo credit: ACLA)
However, with the government shutdown halting normal committee business and delaying budget negotiations, the RESULTS Act—along with various other bipartisan healthcare bills—remains stuck in legislative limbo. For laboratory leaders, that means more uncertainty and a narrowing window for action before the 2026 cuts take effect.
The coalition letter concluded, “We stand ready to help advance the RESULTS Act to achieve fundamental reform of the flawed Medicare clinical laboratory payment system.”
A new KFF poll shows Americans’ trust in the CDC has dropped to its lowest point since COVID-19, creating an opportunity for clinical laboratories to become trusted local voices in public health.
An article from CIDRAP recently reported that public trust in the Centers for Disease Control and Prevention (CDC) has fallen to its lowest level since the start of the COVID-19 pandemic, according to a KFF poll. The decline comes amid renewed misinformation about vaccines and autism and reflects growing skepticism toward the agency from both sides of the political spectrum.
The survey, conducted September 23–29 among more than 1,300 adults, found that only 18% of respondents have “a great deal” of trust in the CDC to provide reliable vaccine information, and 32% have “a fair amount.” That means just half of Americans have at least some trust in the CDC—down from 63% in 2023 and 57% as recently as mid-2025.
The findings followed remarks by President Donald Trump linking acetaminophen use in pregnancy to autism and calling for the measles, mumps, and rubella (MMR) vaccine to be split into three separate shots, claims that lack scientific evidence.
The erosion of trust, however, extends beyond political statements. While conservatives have long viewed the CDC with suspicion over perceived government overreach during COVID-19, many liberals now express frustration with what they see as inconsistency and political influence within the agency.
Higher Trust in Professional Medical Organizations
Interestingly, trust remains higher in professional medical organizations. Sixty-nine percent of parents polled said they trust the American Academy of Pediatrics, and 64% said they trust the American Medical Association.
“It’s encouraging, if far from ideal, that as trust in our nation’s scientific agencies crumbles, the public does trust the professional associations who have stepped forward,” said KFF president and CEO Drew Altman, PhD, in the organization’s press release. (Photo credit: KFF)
Support for Health and Human Services Secretary Robert F. Kennedy Jr. and his “Make America Health Again” (MAHA) movement was also low, with 62% disapproving of his handling of vaccine policy and 59% disapproving of his overall job performance.
What Labs Can Do
Amid this erosion of trust in federal health leadership, local clinical and public health laboratories may be poised to fill an emerging gap. Because labs are often the first to detect spikes in testing volume or positive results, they have a front-line view of disease trends—sometimes days or weeks before such patterns are visible nationally. If skepticism toward the CDC continues to grow, local labs could play an increasingly vital role in identifying and communicating outbreaks, especially during flu season or in the event of a new respiratory virus surge.
Beyond surveillance, labs can also help rebuild confidence in science by engaging their communities directly. Educational outreach, transparent data sharing, and collaboration with local healthcare providers can position laboratories as trusted sources of public health information, at a time when trust in national institutions is faltering.
As the CDC works to rebuild its credibility, laboratories across the country have a unique opportunity to step into the information void by translating data into understanding, and helping restore the link between diagnostics, public awareness, and trust in science.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Lawmakers are renewing efforts to tackle the national clinical lab staffing crisis with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025, a bipartisan bill that would expand training grants and loan forgiveness programs to strengthen the medical laboratory workforce.
Efforts to address the nation’s clinical laboratory staffing crisis have regained momentum with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025. The bipartisan legislation, introduced by Rep. Jen Kiggans (R-VA-02) and Rep. Deborah Ross (D-NC-02), seeks to bolster recruitment and retention across a profession facing severe shortages.
According to a September press release from Kiggans and Ross, the bill is designed to “address the nationwide shortage of clinical laboratory professionals” by expanding eligibility for the National Health Service Corps (NHSC) to include medical laboratory personnel and establishing new federal grants for accredited colleges and universities to train future lab workers.
“Across the country, clinical laboratories face vacancy rates as high as 25%,” the release stated. “These shortages strain healthcare delivery, lead to longer wait times for patients, and contribute to burnout among existing lab staff.” The lawmakers noted that laboratory professionals are essential to healthcare operations, as “doctors depend on the diagnostic work done by laboratory professionals for nearly 70% of their medical decisions.”
“As a nurse practitioner, I know that access to quality healthcare depends on having the right professionals in place at every level,” said Congresswoman Kiggans in the press release. “That’s why I’m proud to join Congresswoman Deborah Ross on the Medical Laboratory Personnel Shortage Relief Act. This important legislation will add medical laboratory professionals to the National Health Service Corps and provide grants to accredited institutions to train more laboratory scientists and technicians.
Rep. Jen Kiggans (R-VA-02) said, “Our nation faces a severe shortage of clinical laboratory professionals—a problem that will only worsen as our population ages. Without enough trained experts, our clinical labs cannot keep pace with the growing demand and complexity of medical testing, which is essential for diagnosing and treating patients. Investing in our medical laboratory workforce strengthens our health system, supports patients, and ensures we are prepared to meet future challenges.” (Photo credit: https://kiggans.house.gov/)
Medical Laboratory Personnel Shortage Relief Act of 2024
The proposal is built upon the Medical Laboratory Personnel Shortage Relief Act of 2024, introduced the previous year before the November elections, as reported by G2 Intelligence. The updated version continues provisions that would amend the Public Health Service Act (42 U.S.C. 254e) to direct the Health and Human Services Secretary to identify areas suffering from shortages of qualified laboratory professionals and deploy NHSC members to those locations.
The act would also establish a Medical Laboratory Personnel Education Program, operated through grants and contracts awarded to accredited nonprofits, allied health schools, and hospitals. These funds would expand training capacity, support internships required for certification, and help recruit qualified faculty which have been longstanding barriers to increasing the pipeline of lab professionals.
In an interview with G2 Intelligence, Jim Flanigan, CAE, executive vice president of the American Society for Clinical Laboratory Science (ASCLS), said the act offers two major advantages: “the establishment of a federal grant program that would allow educational programs to expand the number of students they can train at a given time” and the inclusion of laboratory professionals in the NHSC, which would make them eligible for student loan forgiveness. “Both efforts will help in attracting individuals to the lab career path,” he said.
Rodney Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSC, chair and professor of clinical laboratory science at Texas State University, told G2 Intelligence that he “cannot overemphasize the impact that establishing a program for lab personnel loan repayment will have for building our pipeline in recruiting and retention of students interested in the medical laboratory major and career path.” He added, “Laboratory testing follows patients throughout their lives, from cradle to grave, and it drives about two-thirds of all medical decisions made by doctors and other healthcare professionals.”
Despite the strong backing from organizations such as ASCLS, the Association for Diagnostics and Laboratory Medicine, and the American Clinical Laboratory Association, the bill’s path forward remains uncertain amid fiscal restraint on Capitol Hill. “All programs that incur significant costs are going to face challenges in getting passed,” Flanigan noted.
Still, as G2 Intelligence reported, supporters see the act as a vital “investment in our public health and our invaluable laboratory workforce.”
With Blackstone and TPG acquiring Hologic in an $18.3 billion deal, the IVD industry sees yet another high-value transaction, following the BD-Waters merger and Siemens’ reported divestiture talks.
For laboratory leaders, another major consolidation in diagnostics is underway, according to a press release. Hologic, Inc., a key player in women’s health diagnostics, imaging, and molecular testing, has agreed to be acquired by Blackstone and TPG in a deal valued at up to $18.3 billion, signaling continued investor confidence in the in vitro diagnostics (IVD) sector despite ongoing market volatility.
Industry professionals are taking notice of the broader implications. On LinkedIn, Bruce Carlson, an IVD market specialist with Kalorama Information, noted that Hologic’s sale, “including imaging and IVD assets,” comes at “a 4½x multiple,” calling it “a lot of lettuce, as they used to say.” Carlson added that with multiple large IVD transactions this year, “the question is whether people want out of the business, or want to cash in on values that are up. This multiple seems to argue the latter.”
Featured in the August 4 edition of The Dark Report, a similar move unfolded with Waters Corporation and BD, which recently announced a $17.5 billion merger combining BD’s Biosciences & Diagnostic Solutions business with Waters. The deal will create a major player spanning life sciences and diagnostics, another sign of consolidation and growing investor interest across the IVD sector.
On September 19, Dark Daily reported that according to BloombergSiemens Healthineers is in early talks with Blackstone, KKR, and others about selling its diagnostics division, potentially valued at over €6 billion ($7 billion). If completed, the move would mark another major shake-up in the IVD sector, coming on the heels of the
Waters-BD Diagnostics merger, and could signal further consolidation and portfolio realignment among top diagnostic manufacturers.
The Agreement
Under the terms of the agreement, Hologic shareholders will receive $76 per share in cash, plus a non-tradable contingent value right (CVR) worth up to $3 per share, tied to revenue targets in the company’s Breast Health division in fiscal years 2026 and 2027.
The deal represents a 46% premium over Hologic’s May 23, 2025 closing price, before reports of a potential sale surfaced.
Private equity firms Blackstone and TPG will lead the acquisition, with minority investments from the Abu Dhabi Investment Authority (ADIA) and GIC.
The transaction, pending shareholder and regulatory approval, is expected to close in the first half of 2026, after which Hologic will be taken private and delisted from Nasdaq.
Hologic Chairman, president, and CEO Stephen P. MacMillan said “With their resources, expertise and commitment to women’s health, Blackstone and TPG will help accelerate our growth and enhance our ability to deliver critical medical technologies to customers and their patients around the world.
Hologic Chairman, president, and CEO Stephen P. MacMillan also noted that, “This transaction delivers immediate and compelling value to Hologic stockholders, reflecting the dedication of our employees whose hard work has made this milestone possible.” (Photo credit: Hologic)
For laboratory executives, this move underscores the ongoing realignment of the diagnostics sector, where high valuations and strong post-pandemic revenues continue to draw private equity interest. The deal could influence valuations for mid-tier lab tech firms and diagnostic innovators as investors seek scalable platforms with stable revenue streams.
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Reducing wasteful pre-op testing doesn’t just save money, it streamlines lab operations and strengthens value-based care. Here’s how Michigan hospitals achieved lasting change.
For laboratory leaders, efforts to reduce unnecessary pre-operative testing strike at the intersection of clinical quality, efficiency, and resource management. A new University of Michigan–led study offers evidence that hospitals can safely scale back low-value pre-surgical tests without compromising patient outcomes. Laboratories play a crucial role in making that happen. By streamlining test utilization and aligning ordering practices with true clinical need, labs can help health systems cut costs, reduce workload, and focus resources on the diagnostics that truly guide surgical care.
“Our results show the importance of understanding what factors influence testing decisions at each hospital, and tailoring a multidimensional intervention to that environment,” said Lesly Dossett, MD, MPH, senior author of the paper and a surgeon and healthcare researcher at U-M Health.
The study, published in JAMA Network Open, tracked outcomes at three Michigan hospitals, two community hospitals and one academically affiliated facility, participating in statewide collaborative quality initiatives. Before RITE-Size was implemented, 68% of healthy patients having gallbladder removals, hernia repairs, or breast lumpectomies received at least one unnecessary pre-op test. Six months later, that number had dropped to about 40%, with one hospital achieving a near-zero rate of wasteful testing.
Tailored Interventions Drive Measurable Change
The RITE-Size program was developed through the Michigan Program on Value Enhancement (MPrOVE), a joint initiative of Michigan Medicine and the U-M Institute for Healthcare Policy and Innovation. It builds on earlier work by MPrOVE to identify and eliminate low-value testing in elective surgery settings.
Lead author Nicole Mott, MD, MSCR, a National Clinician Scholar at U-M and general surgery resident at the University of Colorado, said the effort’s success came from a “tailored, team-based approach.” Hospitals began by assessing which tests were routinely ordered for low-risk surgeries, then convened meetings with surgical and pre-op leaders to understand local habits and barriers.
The RITE-Size team provided targeted education, coaching, and easy-to-use support materials. Regular data reports helped teams track their progress and maintain engagement.
Tests targeted for reduction included electrocardiograms, echocardiograms, cardiac stress tests, chest X-rays, urinalysis, and common blood panels. These procedures don’t often influence surgical outcomes for otherwise healthy patients.
An invited commentary accompanying the paper highlighted a key factor in RITE-Size’s success: inclusion of pre-operative nurses. “Too often implementation and quality improvement studies fail to recognize both the value and power held by nurses as part of the health system,” said Clifford Sheckter, MD, MS, of Stanford University. “This study is a great example of how understanding and including this factor led to success of their pilot intervention.”
Expansion Signals a Shift Toward Smarter Utilization
According to Dossett, the findings underscore that waste reduction isn’t simply a matter of enforcing new rules but requires understanding each hospital’s culture and workflow.
Lesly Dossett, MD, MPH, senior author of the paper and a surgeon and healthcare researcher at U-M Health noted, “Tailoring interventions to the local environment and engaging all members of the care team—including nurses and front-line staff—is essential. (Photo credit: U-M Health)
The study was funded by the Agency for Healthcare Research and Quality (Grant 5R01HS029306-02). The collaborative quality initiatives involved are supported by Blue Cross Blue Shield of Michigan.
As hospitals nationwide continue to face pressure to deliver high-quality, efficient care, the Michigan team’s results provide a roadmap for reducing wasteful practices. “We’ve shown it’s possible to right-size testing—and to keep it that way,” Dossett said.
