Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA
Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer.
In the survey, which was conducted by Dark Daily, 91% of respondents said FDA pre-market approval of LDTs would decrease clinical laboratories’ ability to bring innovative tests to market. (See Figure 1.) The other 9% felt it would have no effect on innovation. Zero of the respondents said FDA involvement would increase innovative tests.
Figure 1: “How might a requirement of FDA pre-market approval impact the ability of your lab (or a lab you work for) to bring innovative tests to market?“
“Development of LDT tests has been the mission of most of the labs, and it meets the need for patient care,” noted one respondent in the survey. “Moving LDTs under FDA will create more obstacles for labs to offer the tests.”
To be fair, the survey had limited responses—34 in total. The poll went out to thousands of Dark Daily readers. We found that response rate surprising given how many labs will be affected if the VALID Act becomes law.
The VALID Act is a bipartisan bill that proposes FDA oversight of laboratory developed tests. The bill continues to make its way through the U.S. Senate and the House of Representatives.
A counterproposal called the Verified Innovative Testing in American Laboratories Act (VITAL Act) is also before Congress but has less momentum behind it. The VITAL Act seeks to keep LDTs under CLIA while also calling for reforms to account for modern lab tests.
Looking at survey results, 80% “strongly disagreed” or “disagreed” that new LDT requirements, such as those found in the VALID Act, are needed. (See Figure 2.)
Figure 2: “FDA pre-market approval of LDTs should be required, as proposed in the VALID Act.”
By comparison, 65% “strongly agreed” or “agreed” with modernizing CLIA requirements for LDTs, as called for in the VITAL Act.
Those numbers shifted somewhat depending on the lab setting of the respondent. For example, just looking at commercial labs, opposition to the VALID Act remained similar, but support for modernizing CLIA jumped up to 88%. When looking at just hospitals, independent labs, and academic labs, numbers for both topics remained consistent.
When filtering the answers, the number of lab employees in a setting had little effect on survey results.
Political Battle Continues Over Laboratory Developed Tests
Clinical laboratory industry groups and others have been amassing to oppose or support the VALID Act. For example, the Advanced Medical Technology Association and The Pew Charitable Trusts are behind the bill.
However, the American Association for Clinical Chemistry, Association for Molecular Pathology, and new Coalition for Innovative Laboratory Testing are against the VALID Act.
Gottlieb will speak about the state of AI in healthcare at the event May 11-12
Medical technicians in clinical laboratories and pathology groups may worry that artificial intelligence (AI) will eventually put them out of their jobs.
However, that’s not likely to be the case, according to former Food and Drug Administration (FDA) Commissioner Scott Gottlieb. He was just announced as a top speaker at the Artificial Intelligence in Healthcare and Diagnostics (AIHD) Conference, which takes place May 10-11 in San Jose, Calif.
Instead, expect AI in healthcare to help labs better aggregate and analyze an ever-growing repository of clinical data.
“As we start to digitize more of this information, build out bigger repositories, and correlate more of this information with experimental evidence that’s also captured digitally, it’s going to become an immensely powerful tool,” Gottlieb said during a 2021 webinar hosted by Proscia, which develops pathology software embedded with AI.
Former FDA Commissioner Scott Gottlieb said AI in healthcare will “become an immensely powerful tool.” (Photo courtesy of: Worldwide Speakers Group)
“[AI is] going to be a predictive tool,” he continued. “So, now you start to think about digital data from traditional pathology, digital data from characterizing tumors to sequencing, alongside digital data capture through electronic health records. And you start to have a really powerful, robust set of information.”
Writing for MobiHealthNews last year, Liz Kwo, MD, also noted the potential of AI to deal with unstructured data—in other words, information that is not in a pre-set data model and thus difficult to analyze.
“In many cases, health data and medical records of patients are stored as complicated unstructured data, which makes it difficult to interpret and access,” wrote Kwo, who is Deputy Chief Clinical Officer at insurer Anthem and Faculty Lecturer at Harvard Medical School.
“AI can seek, collect, store, and standardize medical data regardless of the format, assisting repetitive tasks and supporting clinicians with fast, accurate, tailored treatment plans and medicine for their patients instead of being buried under the weight of searching, identifying, collecting and transcribing the solutions they need from piles of paper formatted EHRs,” she added.
AIHD conference to explore the state of artificial intelligence in healthcare
At AIHD, Gottlieb will take part in a fireside chat and also contribute to a panel discussion with other keynote speakers.
“There’s no better individual than Dr. Gottlieb to address AIHD participants about the state of artificial intelligence, where it’s going, how it’s regulatory oversight will unfold, and what’s likely to be the most surprising contribution of AI in patient care,” said Robert Michel, founder of AIHD, Executive Director of the Precision Medicine Institute, and Editor-in-Chief of clinical lab intelligence publication The Dark Report.
The event will bring together senior-level representatives from AI companies, hospitals, physician offices, and diagnostic providers.
Gottlieb promoted greater use of digital tools for clinicians
“I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today,” Gottlieb stated at the time. “These tools can provide more time for intervention, identifying effective therapies and ultimately saving lives.”
During and after his tenure at the FDA, he has been a prolific commentator about the SARS-CoV-2 pandemic and steps public health agencies have taken to curb COVID-19.
Gottlieb is currently a Senior Fellow at the American Enterprise Institute, a public policy think tank. He is also partner at venture capital firm New Enterprise Associates and serves on the boards of Pfizer and Illumina.
Senators Edward M. Kennedy (D-MA) and Gordon H. Smith (R-OR) yesterday introduced a bill in the Senate that aims squarely to control laboratory-developed tests, also known as ‘home brew” tests. The trigger for this bill is the growing role of genetic technology in laboratory testing. Also, the appearance of Web sites purporting to sell genetic tests directly to consumers has created a concern in some quarters that regulation of laboratory tests can help keep scam artists and bad science out of the marketplace.
First and foremost, the bill, S.736, would require all laboratory-developed tests to be labeled with their intended use, along with a statement if the test has not been approved under this new Laboratory Test Improvement Act [Jude – Publish the PDF of the Bill on DarkDaily.com somewhere and link to it!] for such intended use. Should this bill pass, laboratories would be required to comply within 60 days of the bill becoming law.
Labeling laboratory-developed tests is just one part of this bill. It also mandates creation of a public database of information on validity of laboratory-developed tests. This database will contain explicit details on the intended use of all laboratory-developed tests that are not yet cleared by the Laboratory Test Improvement Act. This database would be maintained by the Secretary of the Food and Drug Administration, and would be available to and searchable by the public on the FDA website. Submission of laboratory-developed test data to the database would be required within one year of the bill passing.
The act also lays out three specific classes of laboratory-developed tests. Class III laboratory-developed tests are tests that are intended for use in the diagnosis of a contagious disease or condition that is highly likely to result in a fatal outcome. It is expected that special provisions will be made to allow these tests to get through the more quickly get through the verification process defined in the Laboratory Test Improvement Act.
How will this bill directly affect labs that produce their own laboratory-developed tests? More red tape…along with more development costs because of the need to properly document all tests and filter the information to federal regulators with appropriate forms. Does this bill amount to better quality of care for patients, as intended by Senators Kennedy and Smith? It certainly aims to make it blatantly obvious as to how each laboratory-developed test is to be used. It also gives the public access to information about which specific tests have or have not passed this Act.
In the long run, enactment of this proposed legislation is likely to impede the ability of legitimate clinical laboratories to develop and offer useful tests to clinicians. After all, many laws do little to deter scamsters and con artists. They continue to rip off consumers by appearing in the nooks and crannies of the system and avoiding law enforcement. It is accredited laboratories, with ongoing compliance programs, that will be forced to endure the burdens of meeting the law’s requirements. Dark Daily also observes that the uncertainty over the consequences of genetic testing is a factor in motivating elected officials to “take action” to protect the public. So the laboratory industry is also likely to see other bills designed to control the genetic genie before it gets out of the lamp.