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

Hosted by Robert Michel

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

Hosted by Robert Michel

Sign In

Abbott Moves to Acquire Exact Sciences

Abbott has announced a $21 billion deal to acquire Exact Sciences, which could accelerate early cancer detection, expand at-home testing, and reshape the diagnostics landscape globally.

Abbott announced on Nov. 20 that it has entered a definitive agreement to acquire Exact Sciences, a move that would expand its presence in the rapidly growing cancer diagnostics market and potentially reach millions more patients. The deal values Exact Sciences at around $21 billion, with shareholders set to receive $105 per share.

If approved, the acquisition would give Abbott control of one of the most influential diagnostics portfolios in the industry, including Cologuard, Oncotype DX, and a growing lineup of liquid biopsy technologies aimed at earlier cancer detection and more precise treatment guidance. The transaction positions Abbott as a key player in the $60 billion U.S. cancer screening and precision oncology market, one of the fastest-growing sectors in healthcare.

The combination of Abbott’s scale with Exact’s oncology innovations underscores a broader shift in the clinical diagnostics market: prevention, early detection, and home-based testing are rapidly evolving from niche innovation strategies into mainstream commercial imperatives. That is a development that clinical lab professionals and pathologists must watch given Abbott’s interest.

The acquisition is expected to be immediately accretive to Abbott’s revenue growth and gross margins, with Exact projected to generate more than $3 billion in revenue this year and sustain high-teens organic growth.

Abbott Chairman and CEO Robert B. Ford described the deal as a natural extension of Abbott’s longstanding focus on high-impact healthcare challenges.

Abbott Chairman and CEO Robert B. Ford noted, “Exact Sciences’ innovation, its strong brand and customer-focused execution are unrivaled,” Ford said. (Photo credit: Abbott)

Exact Sciences CEO Kevin Conroy echoed the sentiment, calling the acquisition an opportunity to expand earlier detection and broaden access worldwide.

Positioning Screening as Part of Primary Care Services

Industry observers agree the deal has vast implications—whether or not it ultimately closes. Consultant and principal at Natel, Eliad Josephson, described in a post on LinkedIn the moment as “a pivotal shift” for the entire ecosystem. “Diagnostics is on fire with Abbott potentially taking over Exact Sciences,” Josephson wrote in a shared analysis.

Josephson highlighted Exact’s strong at-home screening franchise, anchored by Cologuard, and its strategic fit with Abbott’s global reach and deep ties to primary care. Abbott’s footprint in clinics and retail settings could embed cancer screening more deeply into routine visits, transforming the “front door” of care by making early detection more accessible.

“The ability to shift screening into primary care is huge,” Josephson explained.

He added that if Abbott accelerates adoption of Cologuard and next-generation blood-based screening tests, payer coverage and health system integration could move faster than previously expected, reshaping reimbursement and care pathways.

Beyond the U.S., Abbott’s international presence could propel Exact’s products into new markets far more rapidly than the company could manage alone. With cancer incidence rising globally—affecting more than 20 million people each year—expanding access to early detection tools represents both a commercial opportunity and a major public health imperative.

Navigating Cultural and Operational Hurdles

Still, Josephson cautioned that integration will not be straightforward. He pointed to cultural and operational differences between device-centric organizations like Abbott and lab-centric ones like Exact, as well as regulatory timelines and reimbursement uncertainties.

“Will this be easy? No,” he wrote. “Integrating these models is not easy. But regardless if the deal closes, this moment signals where diagnostics is heading.”

Industry stakeholders—from labs and payers to health systems and investors—will need to reassess how they position themselves in a world where cancer detection is increasingly decentralized, data-driven, and integrated into everyday healthcare.

The deal is expected to close in the second quarter of 2026, pending regulatory and shareholder approvals. If approved, Exact Sciences will operate as an Abbott subsidiary, maintain its Madison, Wisconsin presence, and have CEO Kevin Conroy remain in an advisory role to support the transition.

For now, the industry is watching closely.

As Josephson put it: “Scale matters. Outcomes matter. At-home access matters. Preventive screening is becoming mainstream.”

This article was created with the assistance of Generative AI and has undergone editorial review before publishing.

—Janette Wider

UC San Diego Health Launches First US Blood Test for Testicular Cancer, Setting New Standard for Lab Diagnostics

The CAP- and CLIA-validated microRNA-371a-3P assay promises earlier detection, fewer CT scans, and more precise treatment decisions for a high-risk patient population.

According to a press release, UC San Diego Health has become the first health system in the United States to offer a clinically validated blood test for testicular cancer. This advance could potentially redefine diagnostic workflows, reduce reliance on imaging, and sharpen treatment decisions for a patient population that often faces both overtreatment and missed recurrences.

The assay, more than a decade in development, measures microRNA-371a-3P, a biomarker shown to detect the presence of testicular cancer cells with about 90% accuracy. Until now, clinicians and clinical laboratories have had limited tools to determine which patients require surgery, chemotherapy, or simply surveillance, especially when imaging is inconclusive.

“This CAP and CLIA clinical validation process and test implementation allows us to translate years of research findings into clinical decisions that can genuinely help patients,” said Sarah Murray, PhD, director of medical genetics and genomics at the UC San Diego Center for Advanced Laboratory Medicine and the laboratory leader who oversaw the test’s validation. “The rigorous standards we’ve met ensure that this test is reproducible, reliable and has analytic validity.”

Diagnostic Gap Labs Have Long Aimed to Close

Testicular cancer strikes roughly 10,000 people annually, primarily men between 18 and 45, yet existing serum markers fail to capture the majority of cases. As a result, laboratories and oncologists have historically struggled with staging uncertainty, unnecessary chemotherapy, and delayed recognition of recurrence. About one-third of patients experience relapses after orchiectomy despite normal CT imaging.

The press release explained that the biomarker’s sensitivity and specificity offer a clearer, earlier signal of active cancer biology—information that can materially change treatment plans.

Further, the test can be used across the care continuum. Before surgery, it can help confirm whether an abnormal testis is malignant and guide surgical decision-making. Post-operatively, it can help determine which patients truly need systemic therapy or further intervention. During surveillance, it may detect recurrence earlier than imaging, allowing less intensive and more precisely timed treatment.

For laboratories, one of the most consequential implications is the potential to reduce the reliance on repeated CT scans, as they carry radiation exposure, cost burdens, and logistical challenges. A validated blood-based alternative, if adopted more widely, could shift surveillance algorithms across health systems.

A Model for Translational Collaboration

The test is currently available for patients at UC San Diego Health and will open to external referrals later this year, allowing outside clinicians and pathology departments to submit samples. It is fully CAP-accredited and CLIA-certified, positioning it for broader adoption by cancer centers seeking higher-resolution molecular insight without expanding imaging capacity.

Diane Simeone, MD, director of the Moores Cancer Center at UC San Diego Health noted that international patient inquiries have already begun and emphasized the test’s potential to recalibrate global standards for testicular cancer management.

“This breakthrough represents the kind of investment in innovation that can save lives while improving quality of life for cancer survivors,” said Diane Simeone, MD, director of the Moores Cancer Center at UC San Diego Health. (Photo credit: UC San Diego Health)

For the urology and oncology teams, the test represents years of translational research. For laboratories, it represents a milestone in bringing microRNA-based diagnostics into routine clinical use.

Integrating Results into Multidisciplinary Care

Each test result will feed into UC San Diego Health’s molecular tumor board, a multidisciplinary group that meets every two weeks to review every patient case and interpret biomarker findings in the context of clinical, imaging, and pathological data. For laboratory professionals, this embedded oversight ensures that results are used appropriately and helps refine test performance insights over time.

For labs nationwide, the launch signals a turning point: a real-world, regulated microRNA test with immediate clinical impact—and a template for how laboratory medicine can lead in closing long-standing diagnostic gaps.

This article was created with the assistance of Generative AI and has undergone editorial review before publishing.

—Janette Wider

Johns Hopkins Researchers Develop Blood Test That Detects Cancer Years before Symptoms Occur

Promising results showcase benefits of MCED lab tests and provide hope for continued advancements

In impressive new research, Johns Hopkins School of Medicine has developed a clinical laboratory blood test that detects the presence of cancer years before symptoms present, aiding physicians with early diagnosis and treatment.

The identification of cancer cells comes via bloodstream analysis showing genetic materials shed by tumors and showcases the promise of multicancer early detection screening (MCED) to spot all types of cancer in early stages.

“Three years earlier provides time for intervention. The tumors are likely to be much less advanced and more likely to be curable,” Yuxuan Wang, MD, PhD, lead researcher and assistant professor of oncology at Johns Hopkins, told SciTechDaily.

Kimmel Cancer Center, Ludwig Center, the Bloomberg School of Public Health also participated in the study with the support of the National Institutes of Health (NIH).

The researchers published their findings in the journal Cancer Discovery titled, “Detection of Cancers Three Years prior to Diagnosis Using Plasma Cell-Free DNA.”

Senior study author Nickolas Papadopoulos, PhD, professor of oncology at Johns Hopkins School of Medicine and senior author of the study, notes that an appropriate course of clinical care will be required following any positive result from the new cancer diagnostic blood test. (Photo copyright: Johns Hopkins.)

Johns Hopkins Study Details

To complete their research, the scientists studied plasma samples that came from the NIH study on Atherosclerosis Risk in Communities (ARIC), which was created to examine cardiovascular disease risk factors in heart failure, strokes, and heart attacks, SciTechDaily reported.

The researchers analyzed the samples using “highly accurate and sensitive sequencing techniques to analyze blood samples from 26 participants in the ARIC study who were diagnosed with cancer within six months after sample collection, and 26 from similar participants who were not diagnosed with cancer, ” SciTechDaily noted.

At the time of sample gathering, eight of the study participants had received a positive score on the MCED test. Six of them provided additional blood samples dating back 3.1 to 3.5 years. Four of those samples showed mutations, SciTechDaily reported.

Value of MCED Screening

While the sample size in the Johns Hopkins study is small, results of the tests give patients and their physicians a head start on identifying appropriate treatments and demonstrate the strides already made with MCED screening.

MCED tests are relatively new, and while they continue to lack FDA-approval, their ability to discern various types of cancer and provide advanced detection with helpful results make them a promising approach to early cancer screening, the American Cancer Society (ACS) notes.

“For cancers of all stages, therapies are more effective with a lower disease burden,” the scientists wrote in Cancer Discovery.

MCED tests use blood, saliva, urine, or other body fluids to seek out cancer signs through RNA, DNA, or proteins from abnormal cells that may be cancerous. Current screening can assist with cervical, breast, colorectal, prostate, or lung cancer, the ACS added.

Spotting Cancer Earlier

The Johns Hopkins scientist believe detection beyond three years early is likely. “In four of these six participants, the same mutations detected by the multicancer early detection test could be identified, but at 8.6- to 79-fold lower mutant allele fractions. These results demonstrate that it is possible to detect [circulating tumor DNA] more than three years prior to clinical diagnosis and provide benchmark sensitivities required for this purpose,” the Cancer Discovery study notes.

“Detecting cancers years before their clinical diagnosis could help provide management with a more favorable outcome,” Nickolas Papadopoulos, PhD, professor of oncology at Johns Hopkins School of Medicine and senior author of the study, told SciTechDaily.

“Of course, we need to determine the appropriate clinical follow-up after a positive test for such cancers,” he added.

—Kristin Althea O’Connor

;