MeMed, a company focused on advanced host response technologies, recently announced Food and Drug Administration (FDA) 510(k) clearance for the MeMed BV test on whole blood samples. Designed for use on the point-of-care MeMed Key analyzer, the test helps healthcare providers distinguish between bacterial and viral infections in 15 minutes. MeMed BV does this by measuring multiple proteins present in low concentrations in a small volume of whole blood.
An earlier version of the test conducted on serum—cleared by FDA in 2021—is being rolled out in medical centers on the MeMed Key platform and on high throughput analyzers via partnerships with other diagnostic companies.
This newer version of MeMed BV eliminates the need for clotting and spinning and requires minimal handling and maintenance. This ease of use makes it appropriate for decentralized U.S. settings, including urgent care centers, according to the company.
MeMed officials believe the test’s FDA clearance will help more physicians accurately distinguish bacterial and viral infections, reducing unnecessary antibiotics use, a key driver of antibiotic resistance.
T2 BIOSYSTEMS EARNS FDA BREAKTHROUGH DEVICE DESIGNATION FOR CANDIDA AURIS TEST
T2 Biosystems, which specializes in rapid detection of sepsis-causing pathogens and antibiotic resistance genes, has announced Food and Drug Administration (FDA) Breakthrough Device designation for the company’s Candida auris (C. auris) molecular diagnostic test. The test detects C. auris directly from blood in 3-5 hours, eliminating the need to wait days for a positive blood culture. Once the test receives FDA authorization, T2 Biosystems plans to add it to the menu of its FDA-cleared T2Dx Instrument.
C. auris is an often deadly, multidrug-resistant fungal pathogen that poses a serious threat to global health. Because standard laboratory methods do not always correctly identify it, affected patients may get inappropriate treatment.
The recent approval marks the third T2 Biosystems product to receive FDA Breakthrough Device designation. The company was previously granted FDA Breakthrough Device designation for its T2Resistance panel and T2Lyme panel.
FDA APPROVES GASTROINTESTINAL STROMAL TUMOR COMPANION DIAGNOSTIC
The Food and Drug Administration (FDA) has granted approval to Qiagen for its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit) as a companion diagnostic (CDx) to Ayvakit (avapritinib) in patients with gastrointestinal stromal tumors (GIST).
Ayvakit is a tyrosine kinase inhibitor (TKI) approved by FDA in 2020 for adults with unresectable or metastatic GIST who harbor a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. GIST patients with D842V mutations show primary resistance to most TKIs. By detecting these mutations, Qiagen’s test will help clinicians identify GIST patients who might not respond to other TKIs but who could receive Ayvakit.
The therascreen PDGFRA kit uses real-time qualitative PCR and is the first platelet-derived PDGFRA assay to receive FDA approval as a CDx. Qiagen officials hope that the kit’s quick turnaround time will speed treatment decisions for GIST patients. Additionally, the approval expands Qiagen’s already extensive list of FDA-approved companion diagnostics.
COMPANION DIAGNOSTIC FOR TWO CANCER DRUGS RECEIVES EUROPEAN IVDR CERTIFICATION
Agilent Technologies recently announced that its PD-L1 IHC 22C3 pharmDx, Code SK006 assay received companion diagnostic (CDx) Class C IVDR certification. This assay had previously been CE-IVD-marked for sale in the European Union. It is now certified in accordance with the new European Union regulation for in vitro diagnostic medical devices (IVDR).
The test is indicated as an aid in identifying certain cancer patients for treatment with Keytruda (pembrolizumab), Merck’s anti-programmed death-ligand 1 (PD-L1) therapy, and Regeneron’s anti-PD-L1 therapy Libtayo (cemiplimab). The IVDR certification covers five CDx cancer indications for Keytruda. These are non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, and triple-negative breast cancer. The IVDR certification also covers NSCLC for Libtayo.
PD-L1 is a critical biomarker for response to anti-PD-L1 therapy, the company said, and its PD-L1 IHC 22C3 pharmDx is already widely used by pathology laboratories to identify cancer patients eligible for treatment. At the same time, oncologists are increasingly selecting patients for treatment with anti-PD-L1 therapies in indications across a growing range of cancer types.
This IVDR certification allows healthcare professionals and patients to continue to benefit from the assay without disruption to critical diagnostic capabilities in established indications, the company added.
NEXT-GENERATION CANCER TESTS GET CE MARK
Three next-generation sequencing-based cancer kits marketed by Toronto, Canada-based Geneseeq Technology have received the European Union’s CE mark.
The tests with new CE mark designation are GeneseeqPrime NGS Tumor Gene Detection kit (GeneseeqPrime), Geneseeq Homologous Recombination Deficiency Detection kit (GeneseeqPrime HRD), and Geneseeq Blood Cancer Gene Detection kit (Hemasalus DNA/Hemarna RNA).
The GeneseeqPrime kit uses a set of 437 genes linked to solid tumors. The reportable range includes single nucleotide variants, indels, copy number variants, gene translocations and large genomic rearrangements, as well as tumor mutational burden, microsatellite instability, and DNA mismatch repair genes. Test data informs and guides therapeutic decisions and offers crucial insights into pivotal oncogenic genes and possible mechanisms of drug resistance.
Apart from the data provided by GeneseeqPrime, the GeneseeqPrime HRD report also incorporates the homologous recombination deficiency status that can be used for recommendations in PARP inhibitor treatments. The Hemasalus DNA/Hemarna RNA investigates genetic variations and translocations in 475 genes at the DNA level, while also identifying translocations in 232 genes at the RNA level. This kit aids clinical diagnosis and facilitates treatment planning for individuals afflicted by hematological malignancies.