FDA approves improvement to home colorectal cancer test sample collection

Geneoscopy recently announced Food and Drug Administration (FDA) approval to streamline the stool collection process for ColoSense, its RNA-based colorectal cancer (CRC) screening test.

To ease use and reduce barriers to at-home screening, the collection kit no longer requires patients to separate samples into multiple containers, Geneoscopy said.

This improvement is expected to increase patient compliance, lower the rate of collection errors, and reduce the frequency of invalid samples. The ease of use may translate into fewer missed screenings and a greater overall impact on population health, the company added.

ColoSense is indicated for individuals aged 45 and older who are at average risk for CRC. It detects biomarkers associated with CRC and advanced adenomas (AAs). As the only FDA-approved RNA-based test for CRC screening, ColoSense has demonstrated 93% sensitivity for CRC and 45% sensitivity for AA in average-risk individuals overall. Among average-risk individuals ages 45 to 49 who face rising CRC incidence, the test demonstrated 100% sensitivity for CRC and 44% sensitivity for AA, Geneoscopy said.

The National Comprehensive Cancer Network guidelines include ColoSense, based on an evaluation of the strength of its clinical evidence and the robust science behind the technology. The test will be available through Geneoscopy’s strategic collaboration with Labcorp, which expands access for providers and patients across the United States, the company said.

FDA APPROVES ROCHE RESPIRATORY VIRUS TEST WITH NEW TECHNOLOGY

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Roche Diagnostics cobas Respiratory 4-flex, the first FDA-cleared assay utilizing Roche’s innovative temperature-activated generation of signal (TAGS) technology.

TAGS technology streamlines respiratory testing and ensures timely and accurate diagnoses for patients.

The test offers qualitative detection and differentiation of SARS-CoV-2, influenza A and B, and respiratory syncytial virus in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection, along with clinical and epidemiological risk factors.

The test consolidates the targets into a single, efficient assay that integrates seamlessly with Roche’s cobas 5800, 6800, and 8800 molecular lab instruments, Roche said.

The test includes a “digital reflex” option which allows for additional testing from the same sample.

FDA APPROVES COMPANION DIAGNOSTIC FOR NEW NONSMALL CELL LUNG CANCER TREATMENT

Thermo Fisher Scientific has received Food and Drug Administration (FDA) approval for its Oncomine Dx Target Test as a companion diagnostic to identify nonsmall cell lung cancer (NSCLC) patients who may be candidates for Hernexeos (zongertinib tablets), a tyrosine kinase inhibitor developed by Boehringer Ingelheim.

The test allows clinicians and pathologists to assess whether NSCLC tumors harbor human epidermal growth factor receptor 2 (HER2) tyrosine kinase domain activating mutations in ERBB2, the gene that encodes HER2.

Among those diagnosed with NSCLC, approximately 2%−4% of patients present with an ERBB2 mutation. In August, the FDA approved Hernexeos as the first and only orally administered targeted therapy for adult patients with unresectable or metastatic NSCLC whose tumors have ERBB2 tyrosine kinase domain activating mutations as detected by an FDA approved test, and who have received prior systemic therapy.

BIOMÉRIEUX PANEL GETS FDA CLEARANCE AND CLIA WAIVER FOR ANTERIOR NASAL SWAB SPECIMENS

bioMérieux recently announced Food and Drug Administration 510(k) clearance and a CLIA waiver for adding anterior nasal swabs (ANS) as a validated specimen type for the Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini, specifically for use with the respiratory test menu. ANS provides significantly more comfort for the patient compared to nasopharyngeal swabs, the company said.

Since the COVID-19 pandemic, sampling methods also have diversified, especially with the adoption of ANS. The swabs have gained widespread recognition for their ease of collection and comparable reliability with nasopharyngeal swabs.

Launched in the United States in 2024, the Biofire Spotfire R/ST Panel Mini is a single multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory and sore throat infections in about 15 minutes. The test already offered nasopharyngeal swab and throat swab options.

LABCORP GETS IVDR CE MARK FOR PGDX ELIO TISSUE

Labcorp’s PGDx elio tissue received the CE Mark under the European Union’s (EU) new in vitro diagnostic regulation (IVDR), making it the first and only test of its kind in the EU that has been CE-marked for comprehensive solid tumor profiling, the company recently said.

The assay, which also has received clearance from the Food and Drug Administration, supports physicians in delivering guideline-based care for patients with solid tumors. It simultaneously analyzes multiple biomarkers, even with limited tissue samples, to enable insights that can support patient care and clinical management. For many, this could mean the difference between starting an effective patient management plan sooner and facing delays that could impact their prognosis, Labcorp said.

The CE mark provides their biopharma partners with a reliable, regulatory-ready solution to derisk multiyear clinical trial strategies, ensuring continuity in next-generation sequencing testing for trials that will extend beyond the IVDR transition timelines, Labcorp officials said.

MAINZ BIOMED ANNOUNCES REGISTRATION OF COLOALERT IN THE UNITED KINGDOM

Mainz Biomed recently announced today that ColoAlert, a DNA-based colorectal cancer (CRC) screening test, has received official registration with the United Kingdom’s (U.K.) Medicines and Healthcare Products Regulatory Agency and is now authorized for marketing in the U.K.

This milestone follows a technology partnership announced earlier this year with the U.K. lab EDX Medical Group and represents an important step toward making the test broadly accessible to patients across the country.

ColoAlert provides a noninvasive approach to CRC screening by detecting DNA biomarkers in stool samples. The test aims to complement the existing U.K. Bowel Cancer Screening Program — which currently invites around 4 million people ages 50−74 to complete a fecal immunochemical test annually — by providing an additional, accessible option that could help increase participation.

Read the full November-December issue of CLN here.