CLN Article

Regulatory Roundup

Meridian Bioscience Gets CE Mark for Malaria Test

Meridian Bioscience has received the CE Mark for illumigene Malaria, a test developed by Meridian with technical assistance from the Centers for Disease Control and Prevention and Cheikh Anta Diop University of Dakar, Senegal. According to a press release by Meridian, the test can detect the malaria parasite with dramatically greater sensitivity than conventional tests. In clinical trials involving more than 200 patients from Senegal, the test demonstrated 100% sensitivity, and it also detected infected patients who were missed by current methods for identifying malaria.

Illumigene Malaria detects the parasite’s DNA by using molecular loop-mediated isothermal amplification (LAMP) technology. Because LAMP is isothermal, the test can be used at room temperature without the need to heat reagents or the sample, in contrast with current rapid malaria diagnostics that use PCR. Illumigene Malariaalso does not require refrigeration. The test produces results in less than 1 hour and is designed for users who do not have a high level of technical expertise.

CE Mark Given to New Beckman Coulter TSH Assay

Beckman Coulter Diagnostics has obtained the CE mark for the Access TSH (3rd IS) assay for use with the company’s Access family of immunoassay systems. This new test represents the next generation of the Access Hypersensitive hTSH and Access Fast hTSH assays for the quantitative determination of human thyroid stimulating hormone (TSH). As a paramagnetic particle, chemiluminescent immunoassay, the Access TSH (3rd IS) uses human serum and plasma samples and provides third-generation TSH results. It is standardized to the World Health Organization 3rd International Standard (IS) for human TSH (IRP 81/565) and is designed to maximize laboratory workflow with a reagent pack size of 100 tests/pack and 200 tests/kit.

FDA Clears Siemens Hemostasis System

Siemens Healthcare has received Food and Drug Administration clearance for the Sysmex CS-5100 system. The system uses simultaneous multi-wavelength preanalytical sample integrity checks to enable automated standardized sample management and detection of unsuitable samples. Featuring a wide optical spectrum, it allows clotting, chromogenic, immunologic, and aggregation testing capabilities on a single platform. The system is designed to help labs streamline workflows with its ability to connect to Siemens’ automation and data-management offerings, including the track-based Aptio Automation and ADVIA LabCell automation solutions.

RPS Diagnostics Receives Canadian Approval for Respiratory Infection Test

Health Canada has issued a Medical Device License to RPS Diagnostics for FebriDx, a rapid, in-office test that uses a fingerstick blood sample to help identify a pathogen-induced immune response to viral and/or bacterial acute febrile respiratory infection. A nurse or technician can perform the single-use, disposable test during a patient’s initial workup and have results available in 15 minutes. This enables an effective patient treatment plan to be established at the point of care, and could help limit the amount of unnecessary antibiotic prescriptions.

The FebriDx test works by simultaneously detecting elevated levels of Myxovirus resistance A (MxA), an intracellular protein that rises in the presence of acute viral infection, as well as C-reactive protein (CRP). The combined detection of MxA and CRP helps differentiate patients more likely to have an acute viral and/or bacterial infection from less clinically significant microbiologically unconfirmed respiratory illnesses.

GenDx Receives CE Mark for HLA Typing Reagents

GenDx has obtained CE marking for the entire AlleleSEQR product line for human leukocyte antigen (HLA) typing by Sanger sequencing. This product line consists of reagents for HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1, which are intended for use with SBTengine software for high resolution analysis of HLA sequencing data. The HLA-A, -B, and -DRB1 product validation files were reviewed by the notified body Dekra, while the kits for HLA-C, -DPB1, and -DQB1 were self-certified by GenDx. These reagents’ receipt of the CE mark represents the final step of transitioning the AlleleSEQR product line from Quest Diagnostics’ subsidiary Celera Genomics to GenDx.

Dako Lands Expanded FDA Approval for Complementary Test to Include Melanoma

The Food and Drug Adminis­tration (FDA) has approved the expanded intended use of Dako’s PD-L1 IHC 28-8 pharmDx complementary diagnostic to include patients with melanoma. The PD-L1 IHC 28-8 pharmDx first received approval from FDA in October 2015 for non-squamous, non-small cell lung cancer. Physicians can now use the complementary test to determine a melanoma patient’s programmed death-ligand 1 (PD-L1) status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on ­progression-free survival from Opdivo (nivolumab), a therapeutic from Bristol-Myers Squibb. Dako, an Agilent Technologies company, notes that these complementary tests are distinct from companion diagnostics, which are essential for the safe and effective use of a drug. Biomarker testing is not required for the Opdivo + Yervoy regimen or Opdivo as a single agent, but it may provide additional information for physicians regarding the use of Opdivo.

FDA Reschedules Public Workshop to Improve POC PT/INR Testing

The Food and Drug Administra­tion has postponed until March 18 the public workshop on point-of-care (POC) prothrombin time/international normalized ratio (PT/INR) in vitro diagnostic devices. At the time that the February issue of CLN went to print, this workshop was scheduled for January 25 and we erroneously stated that the workshop had already been held.

The workshop aims to identify potential solutions to the scientific and regulatory challenges associated with POC PT/INR devices in order to improve clinical management of therapy with the anticoagulant warfarin. It will take place in Silver Spring, Maryland. For more information, visit