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Legislators from the House and Senate have released a new version of a draft bill aimed at modernizing regulations for diagnostics. For two years now, Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO), members of the House Energy & Commerce Committee, have been working to advance a draft of the so-called Diagnostic Accuracy and Innovation Act (DAIA) that they penned with extensive input from lab and diagnostic industry players. A few months ago, the US Food and Drug Administration submitted its ideas for regulating diagnostics that departed extensively from that earlier draft, and suggested a precertification program as the centerpiece of a new oversight framework. It seems now that Bucshon and DeGette, with support from members of the Senate Committee on Health, Education, Labor, and Pensions, Michael Bennet (D-CO) and Orrin Hatch (R-UT), have incorporated the agency's ideas into a discussion draft of a bill, called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which features the precertification program. The term IVCT refers to in vitro clinical tests, a new category that was introduced in the earlier draft of the bill, DAIA, and comprises test kits and lab-developed tests. DeGette's office issued a statement upon releasing the draft bill on Dec. 6 highlighting that the aim is to "establish a framework for overseeing IVCTs … at the FDA." "Advanced diagnostics are transforming the way we provide care for patients in the 21st century, giving rise to precision medicine and enabling physicians to provide more individualized treatments for patients. Unfortunately, the regulatory framework for diagnostic testing has become outdated and is still stuck in the 20th century," Bucshon said in a statement. "Our goal with this draft legislation is to ensure patients can get the most appropriate treatment for their disease by creating a new regulatory framework that is risk based, creates a level playing field, allows for leading-edge development to thrive, and assures doctors and patients that their test results are valid and clinically meaningful." The FDA has historically exercised enforcement discretion over LDTs, leaving the Centers for Medicare & Medicaid Services to oversee them under the Clinical Laboratory Improvement Amendments. But, in recent years the FDA has wanted to end its enforcement discretion, which the lab industry and pathologists have fought against, challenging the agency's authority to regulate lab processes and maintaining that such a move would hinder innovation and harm patients. Labs and testmakers, wanting to limit FDA oversight of their industry, had embraced DAIA as a far more workable regulatory option than the draft guidance on LDTs the FDA issued a few years ago. Much to the industry's surprise, in August the FDA provided technical assistance to legislators on DAIA, but instead of providing line edits to the bill's language as is typical, the agency presented legislators with what many experts said was an entirely new framework.

The FDA's version of the bill includes proposals related to premarket approval, provisional approval, and a precertification program, and makes explicit its authority to revoke approval, request raw data, and take corrective action against test developers in order to protect the public health. Anticipating the release of the VALID Act, FDA Commissioner Scott Gottlieb last week issued a definitive public statement on the agency's position on reforming the regulatory framework for diagnostics.  "The marked discrepancy in the scientific review of clinical testing in America doesn't make sense for doctors, patients, innovators, or payors," he wrote. "We know how we got here — FDA historically exercised enforcement discretion over most LDTs. But, today, we need a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that's helping us find new treatments for disease." He noted that the agency aims to focus review resources on the highest-risk tests, and that only around 10 percent of tests will need premarket review. "We'd concentrate individual premarket review on tests that are novel, higher risk, marketed directly to consumers, used at home, or cross-labeled for use with a drug or other therapeutic products," he wrote. The agency also plans to implement post-market mechanisms to track patient harm; require test developers to be more transparent about the performance and limitations of their products; implement lab certification requirements that complement, not duplicate, existing requirements under CLIA, for example; use third-party entities for review and inspection; and advance a pathway to enable earlier patient access to breakthrough tests. The centerpiece of FDA's regulatory reform proposal is precertification, which has intrigued lab industry players as well. In its technical assistance to DAIA, the agency described precertification as a process through which diagnostic developers could garner premarket approval or clearance for one test representative of a group of tests using the same technology and have other elements in common. Approval of that representative test would precertify other tests in the group and allow the lab to launch them without premarket review.

Gottlieb estimated that between 40 percent and 50 percent of tests would qualify for precerfication. "A pre-certification approach would allow the FDA to evaluate a developer and its ability to design and validate a test," he wrote, promoting this as the best way to protect public health and advance innovation. The agency would exempt manual, low risk, custom, low volume, rare disease, forensic, and public health surveillance from pre-market review, though there would be mechanisms in place to allow the FDA to take regulatory action against problematic tests. Currently marketed lab tests would be grandfathered and require the agency's review only if significant changes were made or safety issues came to light. All these ideas have been incorporated into the VALID Act, as a summary of the bill from DeGette's office suggests: "The draft legislation would establish a risk-based approach to IVCT regulation, prioritizing FDA resources for the highest-risk tests that expose patients to serious or irreversible harm. The legislation also would establish a precertification program for lower-risk tests that are not otherwise required to go through premarket review … High-risk tests, such as novel tests, would be required to undergo premarket review to verify analytical and clinical validity. FDA could require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency." It's unclear how industry players will react to the VALID Act. A group of 17 organizations including academic medical centers, physician and top pathologists' groups, wrote to legislators to indicate their disfavor with DAIA, taking particular issue with the extent of oversight the FDA would have over lab processes. The VALID Act makes FDA's authority to regulate IVCTs, and therefore LDTs, explicit. At a conference last month, American Clinical Laboratory Association President Julie Khani noted broadly that there were areas of concern and favorable aspects to the proposal.

The FDA framework is without a clear timeline and would "really immediately place LDTs into that device framework," Khani said. However, the precertification proposal has also "captured the interest" of laboratories, test manufacturers, and academic medical centers as a pathway that might "help with streamlining and setting up efficient regulation," she added.  Meanwhile, statements from legislators co-sponsoring the VALID Act suggest there may be efforts to make this bill a priority next year. "While I am disappointed this bill will not pass this year, I am hopeful that my colleagues will prioritize this legislation in the 116th Congress," said Hatch in a statement. "Americans deserve the assurance that the tests which are utilized in making vital, sometimes life-or-death, decisions, are both accurate and reliable. This bill establishes a sensible, risk-based approach towards regulation of IVCTs that protects innovation in an ever-changing sector of healthcare."