CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
FDA approves AvertD
March 2024—The Food and Drug Administration approved in December the AvertD test, which assesses whether an individual may have an elevated risk of developing opioid use disorder. Its intended use is to inform the decision-making of patients and physicians about the use of oral opioids for acute pain relief.
The test is not intended for use in patients treated for chronic pain.
AvertD is made by AutoGenomics, which is owned by Solvd Health. Solvd is aiming for a launch date early in the second quarter of this year. Physicians will be able to order the test at www.avertdtest.com.
AvertD uses hybridization capture array with automated detection of multiplex PCR products. It’s designed to identify 15 genetic polymorphisms in genomic DNA from human buccal swab specimens. Solvd says it identifies and uses the presence or absence of the 15 variants to assess genetic risk.
Dr. Donaldson
“AvertD uses an algorithm to determine the genotype call for each gene and utilizes the results to predict the patient’s genetic risk for developing OUD by applying a model and using the genotype information to obtain a risk score,” Solvd founder and CEO Keri Donaldson, MD, tells CAP TODAY. The score range is zero to one, and a risk score of greater than or equal to 0.33 indicates an elevated genetic risk, he says.
“The further a patient’s score is from the cutoff value of 0.33, smaller or greater, the more likely the patient was properly classified,” Dr. Donaldson says.
Although genetic predisposition for OUD explains only a portion of overall risk, he says, “by having a tool that can provide genetic insight and a quantifiable score, the pain management and addiction medicine communities can move one step closer to reducing the pain and suffering of OUD and its public health tolls.”
Dr. Donaldson says Solvd is in conversations with the Centers for Medicare and Medicaid Services and private insurers about pricing and reimbursement.
ABPath introduces Histology Primer
The American Board of Pathology launched in February its Histology Primer, an online learning platform exploring the basics of histology. The primer is designed for pathology residents, medical students, and others interested in learning about the histology of human tissue.
The primer’s learning modules are divided into two content sections: basic tissue components and tissue types by body systems. Each module contains written text or users can opt for mini-lectures with slides. At the end of each module, they can test their knowledge by taking a short quiz with the option to share their scores. The primer also offers an opportunity for pathology residents to become familiar with using the virtual microscopy used in board certification exams.
The Histology Primer can be accessed free at https://histologyprimer.abpath.org. For questions or assistance using the primer, contact ABPath at histology.primer@abpath.org.