The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.
The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.
The U.S. Court of Appeals for the Federal Circuit has once again ruled on a patent dispute between Masimo Corp., of Irvine, Calif., and a rival firm, this time with Sotera Wireless Inc., of San Diego serving as the adversary. The Federal Circuit sided with Sotera in decreeing that 17 claims in Masimo’s RE47,218 (the ’218 patent) are invalidated due to the existence of prior art that rendered the claims obvious, but the irony in this litigation is that one of the patents cited by Sotera as prior art, the 6,597,933 patent, was authored in part by Joe Kiani, the founder, CEO and board chairman of Masimo.
Providing the right therapy at the right time has proven more difficult in the world of cancer than in other disease areas thanks to the variability in treatment response, but a new study hints that this problem may be at least partly solved for non-small cell lung cancer (NSCLC). A study presented at this year’s meeting of the American Society for Radiation Oncology (ASTRO) in San Diego shows that circulating tumor DNA (ctDNA) can provide therapeutic guidelines for oligometastatic forms of the disease, including when high-dose radiation therapy may or may not be indicated.
Neve Ilan, Israel-based Nano-X Imaging Ltd., had rocked the world of medical imaging with promises of X-ray imaging systems that provide low-cost tomosynthesis, but the U.S. Securities and Exchange Commission says the company overpromised on the low-cost claim. The SEC said the actual production cost of the Nano-X ARC systems is at least double the $12,000 per-unit figure routinely touted by the company’s former CEO, Ran Poliakine, a factual misrepresentation that helped the company raise $165 million in an initial public offering.
Patients with metastatic brain tumors are among the most desperate of patients for at least a modestly effective treatment let alone a cure, and GT Medical Technologies Inc., of Tempe, Ariz., reported the interim findings from a study of 48 patients suffering from a total of 51 brain metastases. Four-month data from this study demonstrate that implant of the Gammatile device is safe as demonstrated by the lack of adverse events, and these results combined with other data suggest that this device can offer this patient population real hope of surviving one of the deadliest series of afflictions known to humankind.
The U.S. Department of Justice (DOJ) reported on October 2 that Genomic Health Inc. (GHI), now a subsidiary of Exact Sciences Corp., has agreed to pay $32.5 million to settle allegations that the company violated the False Claims Act (FCA). The allegations include that GHI had manipulated the dates upon which a test was administered in order to boost revenues from public health programs, an activity that ended up costing the company double damages.
The U.S. FDA has finally let fly with a draft rule for regulation of lab-developed tests (LDTs), an 83-page document that delves into the legal controversies regarding whether the agency has the requisite statutory authority. However, Allyson Mullen, a director in the D.C. office of Hyman, Phelps & McNamara P.C., told BioWorld that the emergence of this draft rule doesn’t mean Congress won’t eventually be dragged back into the LDT fray, particularly if stakeholders litigate to overturn the draft.
The Advanced Research Projects Agency for Health (ARPA-H) reported the opening of a series of regional offices that focus on both administrative and research assignments, a development that may bolster cures and treatments for tough-to-treat conditions. However, the U.S. House and Senate have different ideas about how much money the agency will receive in 2024, casting a cloud of uncertainty over how many projects the agency will be able to finance in the twelve months that will start on Oct. 1, 2023.
