Summary
The FDA cleared Roche’s Elecsys pTau181 test, a blood-based biomarker for Alzheimer’s disease assessment in patients 55 and older. The CAP requested an exception for physician J-1 visa holders, concerned the proposed four-year visa limit could hinder international medical graduates pursuing pathology careers. The Association for Molecular Pathology and CAP published a consensus recommendation for a simplified next-generation sequencing molecular biomarker report template.
FDA clears Roche’s Elecsys pTau181
November 2025—The Food and Drug Administration cleared Roche’s Elecsys pTau181 test, a blood-based biomarker for use in the primary care setting in the initial assessment of Alzheimer’s disease and other causes of cognitive decline. It measures phosphorylated tau 181 protein in human plasma and is intended for patients 55 and older who present with signs, symptoms, or complaints of cognitive decline.
The test’s performance was evaluated in a multicenter, noninterventional clinical study of 312 participants. Results demonstrated that in an early-disease-stage, low-prevalence population reflective of the primary care setting, Elecsys pTau181 could rule out Alzheimer’s pathology with a 97.9 percent negative predictive value.
The test was developed in collaboration with Eli Lilly and Company.
CAP requests exception for physician J-1 visa holders
The CAP has requested that the Department of Homeland Security make an exception for physician J-1 visa holders in the U.S. Immigration and Customs Enforcement proposed rule, “Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media.”
In a Sept. 25 letter to Department of Homeland Security secretary Kristi Noem and ICE acting director Todd Lyons, CAP president Qihui “Jim” Zhai, MD, said the CAP is concerned the proposed policy could adversely impact international medical graduates pursuing careers in pathology.
The proposed rule, issued Aug. 28, would limit the term of J-1 visas (along with J, F, and I visas broadly) to a maximum of four years or the length of the relevant education program, whichever is shorter. Applicants would have to apply for an extension at the end of their original visa term.
“While enacting a four-year cap for J-1 visa holders would be sufficient to complete a pathology residency program,” Dr. Zhai’s letter says, “it would not allow time for any subsequent, separate fellowship training after residency.”
Complications could arise as pathology fellowship applications are typically submitted in the third year of residency, he adds, possibly raising such logistical issues as a “pathology fellowship program being forced to consider accepting an applicant without knowing if they’d received a visa extension or a pathology resident attempting to receive a visa extension without proof of acceptance to a fellowship program.”
Similarly, complications could arise as non-U.S. international medical graduates try to apply to the Conrad 30 waiver program, which permits forgoing the two-year home country requirement post-residency and instead beginning immediately to provide patient care in a rural or underserved area for at least three years before becoming eligible to apply for an immigrant visa or permanent residence.
“The unintended consequences of non-U.S. IMGs and programs being forced to make decisions without knowing whether a visa extension will be granted could result in a loss of opportunities for non-U.S. IMGs and American taxpayers,” the letter says, noting the significant amount of money the U.S. has invested in training non-U.S. IMGs.
Also in September, the CAP signed a letter with dozens of other organizations urging the department to issue clarifying guidance that determines that H-1B physician entry into the U.S. is in the national interest of the country, “thereby exempting them from the Proclamation entitled ‘Restriction on Entry of Certain Nonimmigrant Workers.’” The proclamation implements a $100,000 fee, to be paid by the prospective employer, upon initial application for an H-1B visa.
AMP publishes NGS molecular biomarker report template
The Association for Molecular Pathology and the CAP developed a joint consensus recommendation for a provider-friendly next-generation sequencing molecular biomarker report, published recently online ahead of print (doi.org/10.1016/j.jmoldx.2025.08.011).
The AMP’s clinical practice committee convened a multidisciplinary expert panel to create a simplified biomarker report template that physicians could review and use more effectively in providing care. The template “offers recommendations to help laboratories implement the presentation of complex molecular profiling data in a clear, yet guideline-concordant format specifically designed for oncologists and other health care providers,” said Alanna J. Church, MD, chair of the AMP 2025 clinical practice committee and director of innovation in pediatric cancer genomics at Boston Children’s Hospital, in an Oct. 8 news release.
AMP president Jane S. Gibson, PhD, lead author of the paper, said in the release that the joint consensus recommendation is intended to support broader use of NGS testing. She is professor of pathology, chair of the Department of Clinical Sciences, and director of molecular diagnostics at the University of Central Florida College of Medicine.
“Despite the increasing availability of next-generation sequencing gene panel analysis for cancers,” Dr. Gibson and coauthors write, “published reports suggest underutilization of testing, citing the shortage of credentialed professionals available to assist with the interpretation of test results among the key barriers.”