LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts

Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written.

An LDT is a proprietary diagnostic test developed and performed by an individual medical laboratory. In academic center laboratories, LDTs often are created to address an unmet clinical need. Currently, LDTs are primarily regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

That existing regulatory arrangement will change if one of the two pending bills in Congress were to pass and be signed into law. That proposal is known as the Verifying Accurate Leading-Edge IVCT Development Act, or VALID Act. It is a bipartisan, 245-page bill that proposes FDA oversight of LDTs and is making its way through both the Senate and the House of Representatives.

A smaller, seven-page counterproposal is also before the Senate called the Verified Innovative Testing in American Laboratories Act, or VITAL Act. The VITAL Act would keep LDTs under CLIA but mandate updates to CLIA’s rules to account for modern tests.

Readers: Are you in favor of more or less regulation of LDTs? Take this quick survey and let us know what you think.
Dark Daily wants to know your thoughts about LDT oversight. Click here to take our six-question survey. Results of this survey will be reported in a coming Dark Daily e-briefing.

Alert pathologists and clinical laboratory managers know that behind every bill proposed in Congress is a party with a vested interest that brought the issue to a senator or representative. Once enacted into law, a new bill changes the status quo, generally to the benefit of the private interests that requested that bill. This is true of both the VALID Act and the VITAL Act.

The table at the bottom of this briefing compares the provisions of each act and is current as of March 28.

Who Opposes VALID Act?

The VALID Act is garnering more attention than the VITAL Act.

On March 22, the American Association for Clinical Chemistry (AACC) sent out an email message urging its members to oppose the VALID Act.

“Let your legislators know that that if VALID becomes law, your institution and other hospitals and small commercial laboratories could be forced to stop providing LDTs,” wrote Patricia Jones, PhD, DABCC, FACB, Chair of AACC’s Policy and External Affairs Core Committee. The AACC has long criticized the VALID Act..

The Association for Molecular Pathology also opposes the VALID Act, and the Coalition for Innovative Laboratory Testing—an alliance of labs and scientists formed in early 2021—has created a website against the proposed law.

Who Supports the VALID Act?

On the other side of the debate, Philadelphia-based The Pew Charitable Trusts, a nonprofit that in part analyzes publics policy, has come out in support of the VALID Act’s proposed requirements.

*Two bills are pending in Congress about the future of LDT regulation.*

“Although the [current] LDT regulatory process offers labs significant flexibility and enables a more rapid response to public health needs when no FDA-cleared or -approved test exists, the relative lack of oversight for LDTs puts the health of patients at risk,” Pew wrote in an October 2021 report on LDTs.

The Advanced Medical Technology Association also supports the VALID Act, as do many manufacturers of in vitro test kits and large commercial labs. Proponents also believe FDA regulation is needed for IVCTs because they are similar to medical devices and bring with them patient safety concerns.

The American Clinical Laboratory Association and the National Independent Laboratory Association (NILA) have not taken formal positions on the VALID Act.

Congress Could Roll VALID Act into MDUFA Vote to Win Passage

There may be an effort to attach the VALID Act to the authorization vote for the Medical Device User Fee Agreement V (MDUFA), according to a February health legislation alert from law firm Akin Gump Strauss Hauer & Feld based in Washington.

MDUFA funding provides resources to the FDA’s medical device review program. Congress is set to receive final MDUFA V recommendations in April.

Nineteen healthcare and lab industry groups, including the American Medical Association, AACC, AMP, and NILA, sent a joint letter to four Congress members on Feb. 23 requesting they deliberate the VALID Act separately and not as part of MDUFA.

Again, please complete this survey and tell us what you think about FDA regulation of LDTs, as defined in the VALID Act, compared to continuing LDT oversight via a modernized CLIA in the VITAL Act.

—Scott Wallask

Comparison of VALID Act and VITAL Act

	VALID Act	VITAL Act
Full act name	Verifying Accurate Leading-Edge IVCT Development Act	Verified Innovative Testing in American Laboratories Act
Bill numbers	House Bill H.R.4128 Senate Bill S.2209	Senate Bill S.1666
Sponsors	Sen. Michael Bennet (D-CO) , Sen. Mike Braun (R-IN), Rep. Larry Bucshon, MD (R-IN), Sen. Richard Burr (R-NC), and Rep. Diana DeGette (D-CO)	Sen. Rand Paul (R-KY)
Provisions	Developers shall apply for premarket approval of IVCTs if there is insufficient evidence of analytical validity or clinical validity or if it’s reasonably possible an IVCT will cause serious adverse health effects. Applications shall include a summary of test data and scientific evidence to support analytical and clinical validity of the test. Through a technology certification, developers can submit an IVCT to the FDA for review, and if granted, the certification allows them to develop similar tests without going back for review each time. The FDA must establish a program for rapid review of breakthrough IVCTs that provide effective treatment of life-threatening diseases	The federal government should work to ensure that regulatory oversight of laboratory tests does not limit patient access, impede innovation, or limit a test’s sustainability as a result of being unduly burdensome or beyond the fiscal capacity of the laboratory to reasonably validate and perform. No aspects of LTDs shall be regulated under the FDA. No later than 180 days after enactment of the bill, the secretary of health and human services shall report to the Senate’s Committee on Health, Education, Labor, and Pensions about recommendations to update clinical lab regulations and provide an assessment of LDT use during the 2020 pandemic response.
Exemptions	IVCTs being marketed before the VALID Act goes into effect Low-risk tests IVCTs that are granted emergency use	No new exemptions
Review timelines	The FDA shall make a decision no later than 90 days after an application is submitted.	No new requirements noted.