CLN - Regulatory Roundup
The Food and Drug Administration (FDA) recently announced marketing clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test for early detection of amyloid plaques in plasma associated with Alzheimer’s disease.
Is the first blood test for Alzheimer’s, it is intended for adult patients ages 55 years and older who exhibit signs and symptoms of the disease.
The assay measures the proteins pTau217 and ß-Amyloid 1-42 in plasma and calculates the numerical ratio of the levels of the two proteins. The ratio is correlated with the presence or absence of amyloid plaques in the brain. The test reduces the need for positron emission tomography scans.
Clearance was based on FDA review of a multicenter clinical study of 499 individual plasma samples from adults who were cognitively impaired and tested with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Researchers compared results with amyloid PET scan or cerebrospinal fluid (CSF) test results. They found that 91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had amyloid plaques detected by a PET scan or CSF test result, and 97.3% of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.
This test is intended for patients presenting at specialized care settings with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other clinical information.
The Food and Drug Administration (FDA) recently announced marketing authorization for the Visby Medical Women’s Sexual Health Test, the first assay for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and performed entirely at home.
Intended for women with or without symptoms, the test delivers results in approximately 30 minutes.
A single use test, it includes a powered testing device, which communicates securely to the Visby Medical App. The app displays results when the test is complete.
In a study of individuals with and without symptoms, the Visby Medical Women’s Sexual Health Test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.
The authorization opens the 510(k) pathway to other home tests for sexually transmitted infections, FDA officials said.
Diasorin recently announced Food and Drug Administration 510(k) clearance for the Liaison Plex Gram-Negative Blood Culture Assay in the United States and launch of its Simplexa C. auris Direct kit in all countries accepting the CE mark.
The Liaison Plex is designed to identify 27 targets, including 19 gram-negative bacteria and 8 relevant resistance gene targets. It gives results approximately 2 hours after a Gram stain, allowing swift detection of resistance determinants and certain pathogenic bacteria.
The Simplexa C. auris Direct kit helps identify patients with possible Candida auris (C. auris) colonization, aiding infection control in healthcare settings and preventing potentially deadly infections in vulnerable patients.
The real-time PCR assay is used for the direct in vitro qualitative detection of C. auris DNA from a composite swab of axilla and groin and detects all six C. auris clades identified globally. Performed on the Liaison MDX, the test gives results in less than 2 hours.
The Centers for Medicare & Medicaid Services has granted EntroGen national coverage for its CRCdx RAS Mutation Detection Kit, the company announced recently.
The kit is the first Food and Drug Administration-approved, real-time PCR-based companion diagnostic for identifying patients eligible for treatment with Vectibix (panitumumab), based on the absence of KRAS and NRAS mutations.
The coverage decision gives Medicare beneficiaries better access to precision oncology for colorectal cancer and allows labs and providers to “confidently integrate CRCdx into clinical workflows without the barrier of out-of-pocket patient costs, accelerating the adoption of personalized cancer care,” EntroGen said.
Pillar Biosciences recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted coverage for its oncoReveal pancancer solid tumor in vitro diagnostic (IVD) NGS kit.
The kit uses Pillar’s proprietary stem-loop inhibition-mediated amplification technology to detect single nucleotide variants, insertions, and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens.
Additionally, oncoReveal CDx has been approved as a companion diagnostic to identify patients who may benefit from epidermal growth factor receptor tyrosine kinase inhibitor therapy (class approval) in non-small cell lung cancer and Erbitux and Vectibix for KRAS in colorectal cancer.
The oncoReveal CDx has been Food and Drug Administration-cleared on the Illumina MiSeq Dx.
Mursla Bio recently announced Food and Drug Administration (FDA) Breakthrough Device Designation for EvoLiver, a biopsy-based blood test.
Enabled by a novel platform based on organ-specific extracellular vesicles circulating in blood, the test detects hepatocellular carcinoma — the most common form of primary liver cancer — in high-risk patients with cirrhosis.
The designation follows an announcement of the company’s results from its MEV01 multicenter clinical study in which EvoLiver demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance.
EvoLiver could “transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible, and patient-friendly blood test,” Mursla Bio officials said.
The company is advancing regulatory compliance for EvoLiver as a laboratory developed test in preparation for its planned product launch, while also laying the groundwork for future FDA approval through the premarket approval pathway.
Interpace Diagnostics, a subsidiary of Interpace Biosciences, recently announced it will stop offering PancraGEN, a DNA-based diagnostic molecular test that assesses the risk of pancreatic cyst progression to cancer.nterpace stopped offering the test in May after Medicare stopped reimbursing for its cost. The company explained that PancraGEN was primarily ordered for Medicare patients.
Company officials noted that, as a publicly traded company, Interpace “is obligated to help ensure profitability for our shareholders.” Loss of Medicare reimbursement also necessitates the restructuring of the company, they added.