Diagnostics is undergoing a transformation

Abbott’s roughly $21 billion acquisition of cancer screening firm Exact Sciences lays out the company’s future strategy. Analysts said the acquisition not only marks Abbott’s foray into cancer diagnostics, but it also denotes a shift toward preventive care, mirroring broader industry trends and Abbott’s corporate priorities.

The purchase is the largest medtech deal announced in 2025, and would be the largest under Abbott CEO Robert Ford’s tenure, Stifel analyst Rick Wise wrote in a research note

“We have been waiting and expecting that a clearer picture of ‘what’s next’ strategically for Abbott to emerge,” Wise wrote. 

He added that Exact Sciences’ portfolio of cancer screening tests could be Abbott’s next major business opportunity, giving the company access to a roughly $60 billion total addressable market in the U.S. 

Exact Sciences’ flagship product, Cologuard, is a stool-based test for colorectal cancer screening. The company is in the process of rolling out a newer version of the test, Cologuard Plus, RBC Capital Markets analyst Shagun Singh wrote in a research note. 

Cologuard accounts for about 13% of the $18 billion colorectal cancer screening market, Singh added.

Exact Sciences also makes a tumor profiling test used in breast cancer, and recently launched a multi-cancer early detection test and a molecular residual disease test.

Growth of diagnostics business

Abbott expects Exact Sciences to generate more than $3 billion in revenue in 2025.  The medtech giant plans to integrate the company as a subsidiary, bringing sales in its diagnostics business above $12 billion. 

UBS analyst Danielle Antalffy wrote in a research note that a deal makes sense because Abbott has the cash on hand and experience selling to primary care offices with its Libre glucose sensors. Antalffy added that the acquisition could also help performance in Abbott’s diagnostics business, which has been weak. 

Currently, the companies expect about $100 million in pre-tax synergies by 2028, but the analysts see more opportunities. Since most of Exact Sciences’ sales are in the U.S., Stifel’s Wise said that Abbott could help grow its international footprint. Support from Abbott could also help speed up innovation initiatives at the company.

Looking to the long-term, Abbott may face questions about the future of Exact Sciences’ Cologuard franchise as competitors introduce blood-based cancer tests, BTIG analyst Marie Thibault wrote in a research note. Abbott views blood-based tests as expanding the broader market, and Exact Sciences also has an exclusive licensing agreement with Freenome for its blood-based colorectal cancer screening.

Freenome said its updated blood-based colorectal cancer screening test met its primary and secondary endpoints in a pivotal validation study. Called SimpleScreen CRC, the new test showed improvement over an earlier version, particularly in detecting precancerous lesions. 

Abbott, which inked a collaboration agreement with Freenome in August 2025 to bring SimpleScreen CRC to market, will commercialize the test when it gains Food and Drug Administration approval, Freenome said.

The latest study results set up Abbott to be the dominant player in colorectal cancer screening, Evercore ISI analysts said in a note to clients.

Freenome’s screening assay will compete with Guardant Health’s Shield test, which is the first blood test approved by the FDA for primary colorectal cancer screening in average-risk adults age 45 and older.

Blood-based tests to screen for colorectal cancer are intended as an option for people who are resistant to taking a stool test or undergoing a colonoscopy procedure. Freenome said blood-based tests have the potential to reach people who might otherwise remain unscreened.

Abbott, through its $21 billion acquisition of Exact Sciences, sells the Cologuard stool-based test for colorectal cancer screening. 

Freenome’s updated test achieved 80.4% sensitivity for detecting colorectal cancer and 18.2% sensitivity for advanced precancerous lesions. The company’s first-generation test demonstrated 79.2% sensitivity for colorectal cancer and 12.5% sensitivity for detecting advanced precancerous lesions.

Improvements in sensitivity move the updated SimpleScreen test closer to matching the performance of certain stool-based CRC screening tests, with potentially higher patient adherence, Aasma Shaukat, professor of medicine at New York University Grossman School of Medicine, said in a Freenome statement.

Freenome, which submitted a premarket approval application to the FDA in August 2025 for the first-generation version of the SimpleScreen CRC test, said it expects that review to be completed in mid-2026. The company intends to submit a supplemental PMA to the FDA for the next-generation SimpleScreen test.

Freenome’s commercial collaboration agreement with Abbott included a milestone payment tied to the outcome of the study. The payment will be set at $70 million, pending FDA approval of the next-generation test and a successful transfer of the technology to Abbott, Freenome said. Freenome and Abbott are also collaborating on a multi-year R&D program focused on improving assay performance.

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By JR Automation

The medical device sector is confronting a new set of challenges: rising cost pressures, rapid product proliferation, regulatory complexity and shifting global supply chains. Senior leaders are being asked to deliver speed, precision and scalability—all at once. In response, manufacturers are transforming how they design, build and operate production systems through a blend of automation, digitalization and strategic partnerships.

Responding to accelerated product cycles

Product portfolios are growing rapidly, with more launches occurring each year. At the same time, expectations for facility buildouts and production readiness continue to compress. This dynamic is forcing manufacturers to rethink traditional timelines.

Agility has become a competitive differentiator. Companies are prioritizing automation systems that can be deployed quickly and scaled seamlessly, enabling faster transitions from concept to commercialization. Those that can align manufacturing readiness with product innovation cycles will outperform peers in both speed and market responsiveness.

Navigating technology complexity

The expanding technology landscape presents both opportunity and risk. With more vendors offering similar capabilities, selecting the right partners has become increasingly complex.

Successful manufacturers are prioritizing partners who understand the available technology options, offer interoperability across systems and provide long-term scalability. Strategic partnerships are no longer transactional—they are essential to ensuring that operational investments align with broader business objectives.

Flexibility for high-mix production

The rise of personalized and specialized devices has introduced high-mix, low-volume production challenges. Traditional fixed automation models struggle to deliver cost efficiency under these conditions.

Flexible automation is emerging as a critical solution. By enabling rapid changeovers and supporting multiple product configurations, manufacturers can maintain efficiency even with smaller production runs. This flexibility allows organizations to balance customization with profitability—an increasingly essential capability as product diversity expands.

Scaling without reinvention

As organizations expand globally, the question is no longer whether to scale—but how. Leading manufacturers are avoiding costly reinvention by standardizing production platforms. Modular, repeatable automation systems allow companies to replicate validated lines across geographies with minimal redesign.

This fleet-based approach reduces engineering effort, accelerates deployment timelines and improves compliance consistency. For executives, the takeaway is clear: scalable infrastructure is no longer a capital expense decision alone—it is a strategic lever for speed and efficiency.

Digitalization as a core capability

Digital transformation is reshaping the manufacturing landscape. Production environments are evolving into interconnected ecosystems where data drives decisions in real time. Integrated platforms now manage everything from machine control to quality inspection and compliance reporting.

Artificial intelligence and advanced analytics are further enhancing performance by enabling predictive maintenance and real-time optimization.  The focus for leaders is now on integrating systems across IT, operations and cybersecurity to unlock full value.

Accelerating deployment through digital engineering

To keep pace with compressed timelines, manufacturers are leveraging digital engineering tools such as simulations and digital twins. These technologies allow teams to design, test and validate production systems before physical equipment is built.

By identifying issues early and optimizing workflows virtually, companies reduce risk and shorten commissioning cycles. What once required years can now be accomplished in significantly less time—providing a decisive advantage in fast-moving markets.

Advancing quality with a “Right First Time” mindset

Quality expectations continue to rise alongside regulatory scrutiny. In response, manufacturers are shifting from reactive quality control to proactive quality assurance.

Real-time data capture, AI-driven monitoring and integrated analytics enable early detection and correction of process deviations. This “Right First Time” approach minimizes rework, reduces compliance risk and embeds traceability directly into operations. The result is a more resilient quality framework that supports both efficiency and regulatory performance.

Technology as a strategic differentiator

Ultimately, how manufacturers respond to these market challenges will define their competitive position. Technology decisions—spanning automation, digital infrastructure and system integration—are now central to long-term success.

Organizations that take a disciplined, strategic approach will build operations that scale efficiently, adapt quickly and maintain high-quality standards. In a market defined by complexity and change, technology is not just an enabler—it is the defining factor in whether manufacturers lead or lag.

The Food and Drug Administration has approved Guardant Health’s new blood-based genomic test.

Guardant designed the liquid biopsy panel to profile more than 740 genes, compared with the 74 covered by its existing product.

Wall Street analysts, who noted the approval arrived earlier than anticipated, expect Guardant to leverage the benefits of the new test to secure a higher price next year.

The FDA approved Guardant’s previous tumor mutation profiling test, Guardant360 CDx, in 2020. Initially sold as a laboratory-developed test, the new product, Guardant360 Liquid CDx, has 100-fold wider coverage than its predecessor to enable physicians to identify more mutations that may inform cancer treatment. The FDA transferred the legacy test’s seven companion diagnostic approvals to the new assay.

Half of the estimated 200,000 Guardant360 tests sold are LDTs, Leerink Partners analysts said in a note to investors. The analysts expect LDT users to “shift wholesale to this new assay.” Moving customers to the new assay could increase Guardant’s average selling price for the Guardant360 business. 

The Guardant360 CDx price under the Centers for Medicare and Medicaid Services’ advanced diagnostic laboratory test program is $5,000, the analysts said. The LDT version of the new test also commands a $5,000 price, TD Cowen analysts said in a note to investors.

Based on talks with Guardant, TD Cowen analysts estimate the FDA-approved version of the new test could achieve an ADLT price of $6,000 to $9,000. The analysts’ base case is $7,500, while their peers at Leerink said a $9,700 list price is possible. 

TD Cowen and William Blair analysts forecast Guardant could secure a new price in early 2027. Leerink analysts said ADLT pricing could arrive slightly earlier than the previously suggested timeline of 2027. The expectation that Guardant will benefit from higher pricing for most of 2027 is informing forecasts, with TD Cowen analysts seeing a 9% upside to the company’s revenues in 2027. 

The approval could increase volumes of the test, which will face fewer restrictions on its use than the LDT version, William Blair analysts said. Leerink analysts estimate Guardant has maintained a more than 50% share of the market despite “multiple competitive entrants.”

Companies including Roche’s Foundation Medicine compete with Guardant.

Labcorp has made the colorectal cancer screening test ColoSense available nationwide, boosting access to a challenger to Exact Sciences’ Cologuard.

The nationwide rollout comes weeks after the Centers for Medicare and Medicaid Services approved coverage for ColoSense, and the American Cancer Society named the test as a preferred option in its colorectal cancer screening guidelines.

Labcorp secured the right to distribute the test from Geneoscopy in 2023. The Food and Drug Administration approved the test in 2024 and authorized a collection kit in 2025.

Like Cologuard, which the FDA approved in 2014, ColoSense is a stool-based screening test for colorectal cancer. Cologuard detects abnormal DNA and blood, while ColoSense tests for RNA markers and blood. A Geneoscopy-sponsored clinical trial found ColoSense and Cologuard had comparable levels of sensitivity for colorectal cancer and advanced adenomas. 

Geneoscopy has identified the stool sample collection process as a way to differentiate ColoSense from Cologuard. Exact Sciences, now part of Abbott, requires Cologuard users to scrape the surface of their stool with a probe. Users ship the probe and the stool sample in separate containers. 

The ColoSense collection kit eliminates the need to scrape the stool. Users only collect and ship their stool samples. A Labcorp survey found that 41% of at-home screening test users were uncomfortable preparing the sample, and 34% said the process felt messy. ColoSense offers a cleaner, simplified collection process that minimizes sample handling to lower barriers to screening, Labcorp said. 

Exact Sciences has continued to grow Cologuard in the face of competition from ColoSense. Screening sales, which primarily include laboratory service revenue from Cologuard and PreventionGenetics tests, increased roughly 20% to $2.53 billion in 2025. 

In 2023, Exact Sciences filed a lawsuit against Geneoscopy, alleging patent infringement. Geneoscopy hailed a win in the legal battle in February 2026, claiming that a decision removed the last patent hurdle in the way of ColoSense. The Patent Trial and Appeal Board has invalidated all patent claims asserted by Exact Sciences in the litigation, according to Geneoscopy.

Hologic has agreed to be acquired by funds managed by Blackstone and TPG in a take-private deal valuing the company at up to $18.3 billion.

Hologic, which makes diagnostic tools including mammography machines and cervical cancer screening tests, would be delisted from Nasdaq upon completion of the transaction. The company would keep its brand and current headquarters in Marlborough, Massachusetts.

The acquisition is expected to close in the first half of 2026, subject to shareholder and regulatory approval. Hologic’s board unanimously approved the deal.

The proposal follows reports of previous attempts by Blackstone and TPG to take Hologic private. In May 2025, the Financial Times reported that the private equity groups made a $16 billion offer, but Hologic rejected the deal. In September, Bloomberg reported that Blackstone and TPG had renewed their interest in an acquisition.

The latest offer would give Hologic’s stockholders $76 per share, with an additional up to $3 per share if the company meets certain revenue goals for its breast health business in fiscal years 2026 and 2027. The price is a roughly 46% premium to Hologic’s closing price on May 23, 2025, according to the announcement, the last trading day before reports about a potential deal began to circulate.

The deal includes a debt financing commitment letter from Citi, Bank of America, Barclays, Royal Bank of Canada and SMBC, and equity commitment letters from funds managed by Blackstone and TPG. It also includes significant minority investments from a subsidiary of the Abu Dhabi Investment Authority and an affiliate of GIC, Singapore’s sovereign wealth fund.

The agreement includes a 45-day “go shop” period for Hologic to consider alternative proposals.

“We think that this is a fair price for [Hologic] and that other bidders are unlikely,” Needham analyst Mike Matson wrote in a research note.

Matson added that Hologic’s slower revenue growth and potential antitrust issues due to the company’s high share of the U.S. mammography market could dissuade bids from other medtech firms.

Roche has agreed to acquire PathAI, a Boston-based digital pathology firm, for up to $1.05 billion.

Roche plans to pay $750 million upfront and up to $300 million in additional milestone payments, according to a company announcement.

The acquisition is expected to close in the second half of 2026, subject to customary closing conditions, including antitrust and regulatory approvals.

Digital pathology can help automate manual workflows, creating digital images from physical tissue on slides. By having access to digital images, pathologists can use artificial intelligence tools for diagnostic workflows and provide faster results to patients.

PathAI makes AI models that help with the analysis of patient tissue samples and diagnostic tools. Roche has partnered with the company since 2021, expanding their agreement in 2024 to include the development of AI-enabled companion diagnostic algorithms. With the acquisition, Roche plans to scale PathAI’s digital pathology platform globally.

Roche Diagnostics CEO Matt Sause said the company plans to combine PathAI’s digital pathology tools with Roche’s oncology diagnosis platforms.

“Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens,” Sause said in a statement.

PathAI also has solutions for clinical trial support and translational research, which Roche believes will pair well with its expertise in companion diagnostics, helping biopharma companies identify new biomarkers and potential drug targets.

Digital pathology has been the focus of other recent deals. In early 2026, Labcorp expanded a collaboration with PathAI to use its platform at Labcorp’s anatomic pathology labs and hospital sites. In 2025, Tempus AI acquired digital pathology firm Paige for just over $81 million.

The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.

The FDA issued a new final rule that changes the definition of in vitro diagnostics back to language that was in its regulations before the 2024 rule was enacted.

The amendment follows a federal district court order in March 2025 that vacated the controversial 2024 rule after lab industry groups sued to stop its implementation. The FDA declined to appeal the district court’s ruling.

With the now-revoked rule, the FDA had sought to bring LDTs, a category of tests created and used within a single lab, under the same regulatory framework as medical devices and other in vitro diagnostics.

LDTs are currently regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments, with the FDA having enforcement discretion.

“The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely,” the American Hospital Association’s Roslyne Schulman said in a statement.

“This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government,” said Schulman, the AHA’s director of outpatient payment, emergency readiness and public health policy.

The FDA estimated the LDT rule would have cost between $1.29 billion and $1.37 billion annually over 20 years.

Along with the significant growth of genetic testing over the past two decades has come a rise in test fraud schemes targeting Medicare beneficiaries.

Now, the Trump administration is requesting public input on potential regulatory changes to stop fraud in laboratory testing, including genetic and molecular diagnostics. New approaches to regulating the tests could become part of a proposed rule to expand the Centers for Medicare and Medicaid Services’ efforts to combat fraud across federal healthcare programs.

The CMS issued the request for information in February 2026 in a package of actions that included a six-month moratorium on enrollment of new durable medical equipment, prosthetics and orthotics companies in the Medicare program and a pause on $259.5 million in federal Medicaid funds to Minnesota to prevent payment of “questionable” claims under investigation.

In the RFI, the CMS asked stakeholders for input on new statutory or regulatory authorities that could empower the agency to be more effective in preventing and addressing lab test fraud. The request also seeks suggestions for potential tools, data analytics and methods to boost program integrity related to lab tests.

Fraudulent genetic testing has been an ongoing focus of federal law enforcement efforts. In 2019, an investigation by the Department of Justice, Department of Health and Human Services' Office of Inspector General and the FBI resulted in charges against 35 people for allegedly billing Medicare more than $2.1 billion for fraudulent testing. Medicare beneficiaries were lured into signing up for genetic tests that were medically unnecessary.

“There have been a number of cases where people were getting little old ladies to let them do a cheek swab at a health fair or at a nursing home and running genetic tests and never even necessarily giving them the results,” said attorney Danielle Sloane of the law firm Bass, Berry and Sims.

Genetic testing played a key role in another big crackdown in 2025, when 49 defendants were charged with submitting more than $1.17 billion in alleged fraudulent claims to Medicare from telemedicine and test fraud schemes.

“Those cases, in combination with the increase in spending, explains the focus on genetic testing,” said Sloane.

Higher genetic test spending

The RFI pointed to an HHS-OIG report, issued in January 2026, that showed genetic tests make up a rising share of Medicare Part B lab spending. Of the $8.4 billion paid for lab tests in 2024, genetic tests accounted for 43% of the spending but only 5% of the tests, the report found. The portion spent on genetic tests in 2024 more than doubled from 18% in 2018.

“What I take away from that is these are really expensive tests,” said Caroline Farrell, attorney at law firm Foley Hoag. Farrell said costs of fraud related to genetic testing, if prevalent, would add up quickly.

Still, payments for lab services remain a small share — less than 1% — of total Medicare spending, even as beneficiary access to genetic testing continues to grow, said Susan Van Meter, president of the American Clinical Laboratory Association.

The trade group supports the CMS’ anti-fraud initiative, including in diagnostic testing. “Fraudulent actors harm patients, waste taxpayer dollars, and undermine trust in legitimate health care services,” Van Meter wrote in an email to MedTech Dive.

The ACLA is reviewing the RFI and plans to provide detailed comments to the agency. Van Meter said the group would work with the CMS on an evidence-based approach that strengthens program integrity while continuing to support Medicare beneficiary access to lab services, from routine tests to advanced diagnostics.

“These precision diagnostics are the foundation of personalized medicine, providing clinicians with the critical information needed to ensure patients receive the right care at the right time by helping to guide treatment decisions, identify which therapies are most likely to benefit a patient, and avoid unnecessary procedures, ineffective treatments, or preventable complications,” Van Meter wrote.

Foley Hoag’s Farrell said ridding the industry of bad actors is good for legitimate testing companies, but government enforcement efforts that are too broad could create issues for those businesses. While the Trump administration has touted an aggressive deregulatory agenda to support innovation, increasing anti-fraud regulations could have a chilling effect.

“Companies may not want to expand into new areas, test types, because they're concerned about being a target,” said Farrell.

Whether that happens ultimately depends on the government’s ability to come up with precise detection and prevention strategies that can thwart fraudsters.

“At the end of the day,” said Farrell, “the devil’s going to be in the details.”

MolDX as a prototype?

Of specific interest to the CMS is the Molecular Diagnostic Services program, or MolDX, administered by Medicare contractor Palmetto GBA.

MolDX sets Medicare coverage policies for molecular diagnostic tests across 28 states. The CMS, in its RFI, asked for feedback about the program’s impact on fraud risk in testing and what prompted payers and Medicare Advantage organizations that are not located in a MolDX state to require labs to register in the program.

Farrell said the CMS could be looking to propose a mandatory version of MolDX registration.

“The request for comments will help steer what any proposal like that might look like,” said Farrell.

Bass, Berry and Sims’ Sloane said labs in the MolDX program face a higher administrative cost burden. With many labs operating on tight margins, there is a delicate balance between ensuring accurate testing that is serving the practitioner caring for patients and not stifling innovation. 

“If there's going to be expanded use of the MolDX program by Medicare, the government should provide consistency and oversight to make sure it is applied uniformly,” said Sloane.

The Food and Drug Administration has authorized the first artificial intelligence tool to predict patients’ five-year breast cancer risk from a routine mammogram. 

Boston-based startup Clairity developed the tool, called Clairity Breast. The company planned to launch the risk assessment feature by the end of 2025, according to an announcement.

“We're doing something radically different than what I've done my whole career in the area of computer-aided detection and diagnosis of breast cancer,” Connie Lehman, founder of Clairity and a diagnostic radiologist at Mass General Brigham, said in an interview. 

AI has been used to detect breast cancer for decades; the first computer-aided detection system for breast cancer was approved in 1998, Lehman said. However, most of these tools are used to detect cancer, not predict future risk.

“What we’re doing here is doing something humans can’t do,” Lehman said. “It’s extracting subtle cues in the mammogram that the human eye can’t see, the human brain can’t process.”

About 2.3 million new cases of breast cancer were diagnosed worldwide in 2022, according to the latest data from the World Health Organization. Current risk models factor in age and family history, but most people diagnosed have no family history.

Lehman, who has focused most of her career on better ways to detect breast cancer early, expects the new approach will “expand the net out to more women who truly are at high risk, and until now we haven’t been able to identify.”

Clairity Breast was developed using Hologic’s 2D screening mammography systems. It would be used as part of a patient’s routine mammogram.

The company was careful to train its AI models on a diverse group of patients, Lehman said, as historically, breast cancer risk prediction models were built on data from predominantly white women. 

Clairity plans to launch the predictive tool starting with select centers and expanding access later this year, Lehman said. The company last year hired Jeffrey Luber as CEO to help lead the market launch. Luber is the former CEO of testing firms Binx Health and Exact Sciences.

Clairity received a $1 million investment from the Breast Cancer Research Foundation in January 2025.

The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.

The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count.

Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.

Sepsis is a severe response to an infection and is responsible for nearly 270,000 deaths each year. It requires prompt treatment, but symptoms can vary across different people. 

Because it is such a big problem, software companies and hospitals have dedicated resources to building early detection tools that can alert clinicians when a patient may be at risk of developing sepsis. These tools have recently come under scrutiny after researchers published a study in 2021 finding a widely used tool developed by electronic health record company Epic Systems only correctly predicted the risk of sepsis 63% of the time before clinician intervention. 

Prenosis CEO Bobby Reddy Jr. said the company decided to take a different approach, seeking FDA clearance before the agency set out that requirement. The company received de novo authorization in April 2024, which will allow its software to serve as a predicate for other sepsis tools. 

Reddy pointed to a culture clash in the space with some companies breaking the rules by marketing their AI products without authorization.

“You have companies that are really used to regulation and rely on trust,” Reddy said in an interview with MedTech Dive, adding that some firms are excited about AI, but don’t have as much of an understanding or culture around regulations. 

“We don’t think it’s right to have this out on the market without third-party validation,” the CEO added. 

The Sepsis Immunoscore has four risk categories: a patient’s rate of sepsis within 24 hours, in-hospital mortality, length of stay in the hospital and ICU admission in 24 hours. The tool is integrated into the electronic health record and displays a number from 0-100 to indicate the risk of sepsis. It also provides a list of all 22 parameters, ranking them in the order of which contributed the most to the increased risk for that patient.

“A lot of clinicians don’t trust AI products for multiple reasons,” Reddy said. “We are trying very hard to counter that skepticism by making a tool that was validated by the FDA first, and then the second piece is we’re not trying to replace the clinician.” 

The tool was cleared based on a 750-person study across three sites. Prenosis ran sub-analyses to assess the tool’s performance across gender, race and health comorbidities. 

Roche Diagnostics started collaborating with the company in 2020 to expand Prenosis’ core dataset and help it work toward FDA clearance.