CLN - Regulatory Roundup
The U.S. Food and Drug Administration (FDA) recently granted Cepheid marketing authorization for the Xpert HCV test and GeneXpert Xpress System, the first point-of care (POC) test for the potentially deadly hepatitis C virus (HCV).
Using a blood sample from the fingertip, the test detects HCV RNA in about an hour. The test may be performed in settings operating under a CLIA waiver, including certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctors’ offices, emergency departments, and urgent care clinics. The test is indicated for adults with symptoms of risk for hepatitis C, but not for use in monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors.
The newly authorized test allows patients to be tested and treated for HCV in a single visit, negating the need for follow-up appointments for test results and treatment. FDA officials said the test may result in hundreds of thousands more HCV patients being diagnosed and treated and less spread of the disease.
The World Health Organization (WHO) has awarded a Roche human papilloma virus (HPV) test prequalification designation for use on the cobas 5800 System and for self-collected samples on the cobas 5800, 6800, and 8800 Systems.
The FDA has also granted the company emergency use authorization (EUA) for its cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated, multiplex, real-time polymerase chain reaction (RT-PCR) assay that runs on the cobas liat system.
The WHO prequalification better enables low- and middle-income countries to use Roche HPV screening solutions, including self-collection, in their national cervical cancer elimination programs, which will greatly increase access, Roche said.
It added that the EUA for the respiratory assay gives the test the potential to provide swift and precise results, expedite clinical decision-making processes, reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes.
bioMérieux’s BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini has received FDA Special 510(k) clearance and a CLIA waiver, the company recently announced.
Used on the BIOFIRE SPOTFIRE system, the test is a multiplex PCR panel that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in about 15 minutes. Samples can be taken from a nasopharyngeal or from a throat swab when a respiratory tract infection is suspected. The BIOFIRE SPOTFIRE system is a POC platform that can run either a large multiplex respiratory test with up to 15 pathogens or the five-pathogen test, allowing clinicians the flexibility to choose the right test, the company said.
The CLIA waiver is key to decentralized testing because it allows non-lab professionals to use the test, especially in urgent care centers, physician offices, local pharmacies, student health clinics, and emergency departments, bioMérieux added.
The FDA granted de novo authorization to the Diasorin Simplexa C. auris Direct kit to test patients with suspected Candida auris (C. auris) colonization and help prevent spread in healthcare settings, Diasorin recently announced.
This real time PCR assay is used for the direct in vitro qualitative detection of C. auris DNA from an axilla/groin swab from patients suspected of C. auris colonization and detects the six C. auris clades that are circulating globally. Run on the LIAISON MDX, the system has a streamlined workflow that yields results in less than 2 hours, Diasorin added.
C. auris is challenging because patients may be asymptomatically colonized. C. auris colonization is a risk factor for invasive infections associated with high mortality rates and often does not respond to commonly used antifungal drugs. The World Health Organization and the U.S. Centers for Disease Control and Prevention have identified C. auris as a fungal pathogen of critical importance.
Diasorin officials said the authorization fills a much-needed gap in C. auris molecular detection and positions their company as the first molecular diagnostic vendor to commercialize a PCR test for the prevention and control of C. auris infection in healthcare settings.
Foundation Medicine recently announced FDA approval for its FoundationOne Liquid CDx test to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech.
AKEEGA is the only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, Foundation Medicine said.
BRCA1- or BRCA2-mutated mCRPC is an aggressive form of the disease, occurring in approximately 11% of diagnoses. The approval allows healthcare providers to leverage a minimally invasive liquid biopsy to identify additional patients with BRCA mutations and insufficient tumor tissue available for traditional biopsy.
FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several other companion diagnostic indications across non-small cell lung cancer, prostate cancer, breast cancer, and colorectal cancer, plus a pan-tumor indication specific to NTRK1/2/3 fusions.
TECHLAB, part of the SSI Diagnostica Group, recently announced that its C. DIFF QUIK CHEK COMPLETE test has received certification under the European in vitro Diagnostic Medical Device Regulation (IVDR).
The C. DIFF QUIK CHEK COMPLETE test is a rapid membrane enzyme immunoassay designed for the simultaneous detection of Clostridioides difficile (C. difficile) glutamate dehydrogenase (GDH) antigen and toxins A and B in a single reaction well. The test provides both GDH and toxin results within approximately 30 minutes, enabling healthcare professionals to differentiate between active C. difficile infection and colonization in a cost-effective and clinically relevant manner, the company said.
The company added that the assay is the first combined GDH plus toxin A/B test to get IVDR certification for a combined GDH plus toxin A/B test.