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Freenome and Abbott recently announced Food and Drug Administration (FDA) approval of SimpleScreen CRC, a new blood-based screening option for colorectal cancer (CRC) in adults ages 45 and older who have average risk for the disease.
Abbott will exclusively commercialize the test in the United States this fall, the companies said.
The test detects signals associated with colorectal cancer from cell-free DNA in blood. The FDA approval was based on results from a prospective clinical validation study that enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45–85 scheduled for screening colonoscopies. In a prespecified analysis adjusted to match the U.S. census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity, including 30.7% for advanced precancerous lesions with high-grade dysplasia. The test showed 90.4% specificity for advanced colorectal neoplasia.
SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals, Freenome and Abbott said.
SimpleScreen CRC expands choices for healthcare providers and helps remove many barriers that keep people from screening, Abbott officials added.
First diagnostic Ebola Bundibugyo test on WHO Emergency Use Listing
The World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV), a type of Ebola virus, to its Emergency Use Listing (EUL).
WHO assessed the genetic blood test for quality, safety, and performance and ensured it meets minimum international standards and addresses low- and middle-income countries’ needs.
Testing capacity for BDBV had increased from up to 400 tests per day to a broader network of labs with a combined capacity of more than 2,000 tests per day, WHO said in July.
Additional applications for BDBV in vitro diagnostics submitted through the EUL procedure are currently under review.
WHO said it is working with other international health organizations on a joint validation platform to rapidly evaluate the performance of a selection of diagnostic products. These include laboratory-based molecular tests, near-point-of-care molecular tests, and antigen rapid diagnostic tests. The platform will generate critically needed clinical evidence on the performance of these products in outbreak settings.
Vaginitis PCR test gets FDA clearance
The Food and Drug Administration (FDA) has granted Roche 510(k) clearance for its cobas BV/CV assay. This diagnostic PCR test provides results for both bacterial vaginosis (BV) and candida vaginitis (CV) from a single vaginal swab sample.
The test detects DNA targets for multiple organisms associated with BV. They include Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus spp. The test also detects Candida species associated with CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, and C. dubliniensis.
The sample is collected using a clinician-collected or clinician-instructed, self-collected vaginal swab in cobas PCR Media in a healthcare setting. This enables diagnosis from a single sample that also can be used for broader sexual-health testing.
Accurate vaginitis diagnosis is a cornerstone of effective treatment, yet misdiagnosis is close to 50%, raising the risk of recurrence, Roche said. Diagnosis remains challenging because of non-specific symptoms. Meanwhile, most tests, including microscopy and pH testing, lack precision.
FDA Emergency Use Authorization granted for ulcerative skin lesion test
Seegene recently announced Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Allplex HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR test designed to detect multiple viral pathogens associated with clinically overlapping lesion presentations simultaneously.
The assay identifies herpes simplex virus type 1 and type 2, varicella-zoster virus, and monkeypox virus. Allplex is the first multiplex PCR test in the United States market designed to simultaneously and differentially detect viral pathogens of ulcerative skin lesions, Seegene said.
The pathogens that the test detects frequently present with similar clinical symptoms, such as vesicular or pustular lesions. They are difficult to distinguish by appearance alone. When clinicians test for only one pathogen at a time, they can miss cases caused by the untested viruses. This product addresses an unmet market, Seegene said.
FDA clears home test for multiple respiratory viruses
Visby Medical has announced Food and Drug Administration (FDA) clearance for its Visby Medical Flu and COVID-19 Test.
The test detects COVID-19, influenza A, and influenza B. It is the first multiviral PCR home test, the company said.
Visby added that the PCR test, which provides results in 30 minutes, detects disease early in the course of infection when viral levels are lower. Early detection is very important because antiviral medication such as Paxlovid and Tamiflu are most effective when begun early.
The test will be eligible for flexible savings account and health savings account reimbursement, Visby said.
Melanoma gene expression profile test gets FDA Breakthrough Device designation
SkylineDx recently announced it has been granted Food and Drug Administration (FDA) Breakthrough Device designation for Merlin CP-GEP, a clinicopathologic gene expression profile (CP-GEP) test designed to support risk assessment and clinical decision-making in patients with stage IB (T1b/T2a) cutaneous melanoma.
These patients have thin tumors up to 2 mm thick with ulceration or slightly deeper growth that has not spread to nearby lymph nodes or distant parts of the body. The patients are a clinically important population in whom accurate assessment of metastatic potential is critical for guiding management, the company said.
SkylineDx added that Merlin is the only commercially available GEP test that combines clinic CP variables with GEP into a single algorithm. Merlin is also the only GEP test that provides a binary stratification of all patients based on being high or low risk for metastasis, and thereby assigns them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines, SkylineDx said.
In conjunction with other established clinical criteria, Merlin CP-GEP supports patient selection for sentinel lymph node biopsy, may inform discussions regarding follow-up strategies, and facilitates shared decision-making between healthcare providers and patients.
Prior to the designation, CP-GEP had already been recognized by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a predictive GEP test that may be used to support metastatic risk assessment and clinical decision-making in T1b and T2a melanoma patients.