Clinical laboratories should closely watch the Trump administration as it contemplates a court appeal, a revised LDT rulemaking, or abandoning the rule altogether
With a US District Court judge’s decision to vacate the Food and Drug Administration’s (FDA) rule on laboratory-developed tests (LDTs), perhaps the most intriguing aspect for clinical laboratories is what the next move will be by the federal government.
It’s hard to predict whether the administration of President Donald Trump will either appeal the judge’s decision, direct the FDA to come up with a new version of the rule that passes legal muster, or simply back off further scrutiny of LDTs.
Let’s look more closely at the options for clinical laboratory professionals to monitor.
US District Court Judge Sean Jordan, JD (above), vacated the federal Food and Drug Administration’s final rule to regulate laboratory-developed tests (LDTs) on March 31, 2025. In a lawsuit, the Association for Molecular Pathologists and the American Clinical Laboratory Association accused the FDA of overstepping its legal authority in issuing the LDT rule in 2024. The outcome of this ruling will affect clinical laboratories’ future development their own tests. (Photo copyright: Jackson Walker LLP.)
Will the Trump Administration Appeal the LDT Decision?
The FDA’s final rule—which came out in 2024 and was about to hit its first compliance milestone on May 6, 2025—had been discussed for at least 10 years prior, covering multiple presidential administrations. Because the final rule was published by the FDA under former President Joe Biden, it surprised some observers to see Trump’s Department of Justice defend the FDA’s right to implement the rule during oral arguments in February before Judge Sean Jordan in US District Court for the Eastern District of Texas.
That hearing was the culmination of a combined lawsuit from American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) challenging the LDT rule. The suit sought summary judgment on the matter, which Jordan granted on March 31 in his decision to vacate the FDA’s rule.
“The Court vacates and sets aside, in its entirety, the FDA’s final rule titled Medical Devices; Laboratory Developed Tests,” Jordan wrote. “The Court remands this matter to the secretary of Health and Human Services for further consideration.”
Trump’s legal team set a precedent early in the president’s second term to aggressively challenge any court decisions that buck his authority. From that perspective, an appeal of the LDT judgment seems probable, although there is no official word yet about that.
Trump ran on an anti-regulatory, smaller government platform. In that sense, the DOJ’s defense of the FDA’s standing to carry out the LDT rule was a surprise.
Will the FDA Create a Revised Version of the LDT Rule?
The court sent the rule back to the FDA, which leaves the door open for the agency to construct and issue a new rule.
The clinical laboratory industry argued that LDTs should not be classified as medical devices, which the rule instead emphasized. That could be an area where a new version of the rule bends.
Congress could also step in here. For many years, a proposed bill known as the VALID Act (formally the Verifying Accurate Leading-Edge IVCT Development Act) was filed in the House of Representatives to increase LDT oversight.
But then—after the FDA’s LDT rule came out—the VALID Act looked to be the lesser of two evils to lab professionals. It’s possible labs and lawmakers could work out a new version of the VALID Act to avoid another potentially onerous FDA-issued rulemaking.
Will Trump and the FDA Do Nothing?
Even though it would go against the current pattern of challenging court decisions, the Trump administration could simply step back and choose to do nothing with the FDA’s vacated rule.
In that case, presumably LDTs would continue to be overseen by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The medical lab industry has long preferred to see CLIA reform as the pathway to regulating LDTs in the future rather than formal FDA involvement. The FDA referred to this arrangement as “enforcement discretion,” as LDT oversight has always been on the books at the FDA, but the agency deferred to CLIA for many years.
Of related interest was a news release last week from the federal Department of Health and Human Services (HHS) announcing a sweeping number of layoffs under its individual agencies. The FDA is slated to lose 3,500 employees, although the “reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors,” HHS noted in a fact sheet.
Revisiting an LDT rule that will require more reviewers and inspectors seems at odds with a shrinking FDA.
Clinical Labs Must Monitor the Near-term Future of LDTs
After coming out ahead in one of the biggest court showdowns in clinical lab history, medical laboratory scientists and industry leaders now must keep their eyes on the various avenues that LDT regulation could head down in the near future.
Watch for further analysis of the business implications of this court decision in The Dark Report.
Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.
“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”
“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)
Arguments For and Against FDA LDT Regulation of LDTs
Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.
Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.
In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.
“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.
“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.
Actions Clinical Laboratory Managers Can Take
Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:
Contact their representatives in Congress.
Find out whether any trade associations they belong to have taken a position on the VALID Act.
Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.
Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs.
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.
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
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.
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.
Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’
Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through.
As Dark Daily’s sister publication The Dark Report, noted in “VALID and SALSA Acts Still Pending in Congress,” a standalone vote on either bill is unlikely this year. Instead, they would need to be attached to the larger spending bill. (If you’re not a subscriber to The Dark Report, check out our free trial.)
In an article for STAT, former FDA Commissioners Scott Gottlieb, MD (left), and Mark McClellan, MD, PhD (right), wrote, “The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The [VALID Act] would strengthen protections for consumers and patients for both diagnostic tests and cosmetics and make it easier for manufacturers to introduce better products.” (Photo copyrights: FDA/American Well.)
Political Parties Negotiating
At press time, a draft spending bill had not yet been introduced to Congress as lawmakers from both political parties negotiate funding levels.
A source told The Dark Report that until legislators hammer out those details, add-ons such as the VALID Act or SALSA are stalled. There is no guarantee either lab measure will be added to the spending bill.
“We don’t have agreements to do virtually anything,” said Senate Minority Leader Mitch McConnell (R-KY) to reporters on Dec. 6, according to Reuters. “We don’t even have an overall agreement on how much we want to spend,” he added. Reuters reported that Democrats and Republicans in the Senate were $25 billion apart in their proposals.
Congress could also pass a continuing resolution to keep the government open for a short time, which would allow lawmakers more opportunity to negotiate.
Former FDA Chiefs Weigh In
Meanwhile, proponents of the VALID Act have publicly turned the heat up for the bill. For example, STAT recently ran two commentaries—including a joint piece from a pair of former FDA commissioners—in support of the VALID Act.
Currently, LDTs are regulated through the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, supporters of the VALID Act argue that the complexity of modern LDTs deserves more scrutiny.
“The VALID Act would create a consistent standard for all tests, regardless of the kind of facility they were developed in or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests,” wrote Scott Gottlieb, MD, and Mark McClellan, MD, PhD, in STAT on Dec. 5.
Gottlieb and McClellan served as FDA commissioners from 2017-2019 and 2002-2004 respectively. They both currently serve on various boards for biotech and healthcare companies.
Pathologists, Clinical Lab Directors Express Concerns about VALID Act
Opponents of the VALID Act contend that LDT innovation will be stifled if clinical laboratories, particularly those at academic medical centers, need to spend the time and money to go through formal FDA approval. There is evidence that working pathologists in academic settings have legitimate concerns about the negative consequences that might result if the VALID Act was passed as currently written.
In “Might Valid Act Support Be Waning in Congress?” The Dark Report covered how on June 1 more than 290 pathologists and clinical laboratory directors sent a grassroots letter to a Senate committee asking for a series of concessions to be made for academic medical center labs under the VALID Act.
It is reasonable to assert that the majority of clinical laboratory professionals and pathologists are supportive of the SALSA bill, which would stop the next round of scheduled price cuts—as much as a 15% price reduction to many tests—to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). That is not true of support for the VALID Act, as currently written. Sizeable segments of the diagnostics industry have taken opposing positions regarding passage of that legislation.
For these reasons, both bills will be closely watched in coming weeks as Congress works to fund the federal government while, at the same time, incorporating a variety of other bills under the omnibus bill, which is a considered a “must pass” by many senators and representatives.
Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing
As former FDA commissioner Scott Gottlieb, MD, explained on Face the Nation, “this kind of technology is a real game changer … it’s a very rapid test that could be used in a doctor’s office. Doctors now have about forty thousand of these Sofia machines already installed in their offices … you do a simple nasal swab and the test itself scans for the antigens that the virus produces.
“The test is about 85% sensitive. So, let’s say a hundred people come into a doctor’s office who have COVID-19, eighty-five of them are going to be able to be tested positive with this test very quickly. It’s a cheap test. It’ll probably be about five dollars a test and you can get a result within five minutes … you’re getting a very fast result and you can start to take action immediately.
“The company itself said that they’re going to be able to produce about two hundred thousand of these tests starting right away. But in several weeks, they’ll be able to produce up to 1.5 million a week. So, this dramatically expands our testing capacity as long as doctors are able to run these tests in their offices.”
In an interview on CBS’ Face the Nation, former FDA Commissioner Scott Gottlieb, MD (above), said, “These antigen-based tests aren’t as reliable, meaning they’re not as sensitive. So, they’re going to miss some patients who have COVID. But in the hands of a doctor who already has a high index of suspicion that the patient may have the disease … they allow you to dramatically expand testing. And they’re very cheap. They’re very easy to perform. And again, most doctors have these machines already in their offices.” (Photo copyright: US Food and Drug Administration.)
Other LDTs That Have Received EUAs
Here’s a look at other laboratory-developed tests from major manufacturers that have received emergency-use authorizations from the FDA:
This test is designed for use with Abbott’s m2000 RealTime system, which is installed in about 200 US medical laboratories, the company says. It can run up to 470 patient samples in 24 hours. As of a May 11 statement, the company said it had shipped more than two million tests in the US.
This test is designed for use with Abbott’s Alinity m system, which the company describes as its “most advanced laboratory molecular instrument,” with the ability to run up to 1,080 tests in 24 hours, according to a press release.
This is a rapid test designed for use with the ID Now system, a compact portable instrument for point-of-care settings such as urgent care clinics. As of May 11, Abbott said it had shipped more than 1.7 million tests in the US, and that it planned to increase manufacturing capacity to two million tests per month.
However, the test has encountered some stumbling blocks. On May 14, the FDA issued an alert stating that the ID Now COVID-19 test could produce inaccurate negative results. This came after researchers at NYU Langone Health, Northwell Health, and Cleveland Clinic reported problems with the test, according to MedTech Dive. Abbott issued a statement suggesting that the problems were due to improper sample collection and handling, however, the FDA said that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.
This is a qualitative test designed to detect the presence of IgG antibodies following a SARS-CoV-2 infection. The FDA authorized use of the assay on Abbott’s Architect i2000SR system in April, and then followed up with a May 11 EUA for its use on the Alinity i system. In a statement, Abbott said it planned to ship 30 million tests globally starting in May.
In a March statement, the FDA touted this as the first point-of-care COVID-19 test to receive an EUA. The company estimates the detection time as approximately 45 minutes. It is designed for use with Cepheid’s GeneXpert Dx diagnostic software and GeneXpert Infinity systems, which have nearly 5,000 US installations, according to a Cepheid statement.
This test runs on Hologic’s Panther system, which, according to a Hologic press release, can provide results in about three hours and run more than 1,000 tests per day. The company claims that more than 1,000 Panther systems are installed in US labs, and that it expects to produce an average of one million tests per week.
Ortho’s antibody test is designed for use with its VITROS XT 7600, 3600, 5600, and ECi/ECiQ immunodiagnostic systems, which, the company says are installed in more than 1,000 US labs. The Total Reagent Pack is a qualitative test that detects the presence of all antibodies against SARS-CoV-2.
On April 24, Ortho announced it had received another FDA EUA, this one for its Anti-SARS-CoV-2 IgG test, which detects the presence of IgG antibodies. In a statement, the company said it expects to produce “several million” IgG tests per month.
This test is designed for use with Roche’s cobas 6800 and 8800 systems. The 6800 can process up to 384 results in an eight-hour shift, Roche says, compared with 1,056 results for the 8800 model. The company says results are available in about 3.5 hours. In a statement, Roche said it planned to ship 400,000 tests per week.
Roche describes this as a qualitative antibody test that can be used on cobas e series immunoassay analyzers. Testing time is 18 minutes. As of May 19, the test was live at more than 20 US labs, “with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week,” the company stated in a press release.
It’s likely the FDA will continue to issue emergency-use authorizations as the agency receives more applications from IVD manufacturers.
