FDA Authorizes First CSF Nucleic Acid Test for Multiple CNS Infection Pathogens

The Food and Drug Administration (FDA) has granted BioFire Diagnostics permission to market the FilmArray Meningitis/Encephalitis (ME) panel, making this the first FDA-authorized cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that cause central nervous system infections. The panel received FDA authorization via the agency’s de novo classification process.

Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests. Additionally, identification of the cause of bacterial and viral central nervous system infections may take up to 3 days or more using current methods. The FilmArray ME panel was developed with the aim of surmounting these challenges. The panel, using a small sample of CSF, simultaneously tests for 14 bacterial, viral, and yeast pathogens that cause meningitis and encephalitis. It also provides results in about an hour, which may enable clinicians to make informed treatment decisions earlier.

The bacteria and yeast pathogens identified by the FilmArray ME panel include Escherichia coli K1, Haemophilus influenza, Listeria monocytogenes, Neisseria meningitides, Streptococcus agalactiae, Streptococcus pneumoniae, and Cryptococcus neoformans/gattii. Viruses that the panel identifies include cytomegalovirus, enterovirus, herpes simplex viruses 1 and 2, human herpesvirus 6, human parechovirus, and varicella zoster virus.

However, the FilmArray ME Panel does not detect all causes of central nervous system infections or provide information about which antimicrobial drugs may be most effective for treating bacterial infections. Therefore, standard CSF bacterial and fungal cultures should still be used in conjunction with the panel to confirm results and to determine drug susceptibility when results are positive.

23andMe Receives FDA Authorization for Downsized DTC Genetic Testing Service

After 2 years of work with the Food and Drug Administration (FDA) and extensive user comprehension testing, 23andMe has received FDA authorization to launch an overhauled version of the company’s Personal Genome Service (PGS) that includes carrier status reports in addition to non-healthcare-related wellness, trait, and ancestry reports. For an increased price of $199, PGS now provides detailed genetic information in a format validated by user testing as easy to understand. Building on the FDA authorization 23andMe received for its Bloom Syndrome carrier test, PGS identifies mutations in 36 different genes that can cause diseases ranging from well-known genetic disorders such as cystic fibrosis and sickle cell anemia to rare conditions such as Nijmegen breakage syndrome and Sjögren–Larsson syndrome. 

These tests, however, are only intended to determine carrier status in adults; not to diagnose a disease or to predict the risk of developing a disease in adults, fetuses, or infants. 23andMe has also not received the green light to resume offering more complex genetic tests that estimate the risk of developing diseases such as breast cancer and Alzheimer’s, which the original PGS included.

Luminex Gets FDA Nod for Aries System and HSV Assay

The Food and Drug Administration (FDA) has cleared Luminex’s Aries system, a sample-to-answer system designed to increase laboratory efficiency, ensure result accuracy, and fit with the modern lean laboratory environment. The system uses features such as internal barcode scanning to minimize operator errors, while two independent modules each support from one to six cassettes, enabling both stat and batch testing. IVD and Luminex’s MultiCode analyte-specific reagents can be run simultaneously on the system with a common universal assay protocol. Additionally, an integrated touchscreen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse to maximize bench space. FDA has also cleared Luminex’s Aries HSV 1&2 assay, which is the first test to be authorized for use on the Aries system.

FDA OKs Cepheid Test for Trichomoniasis

Cepheid has received Food and Drug Administration (FDA) clearance for Xpert TV, a qualitative test that identifies trichomoniasis in symptomatic and asymptomatic female patients using urine, endocervical swabs, or vaginal swabs collected by the patient in a clinical setting. Caused by the protozoan parasite Trichomonas vaginalis, trichomoniasis is the most common non-viral sexually transmitted infection and is associated with a two-to-threefold increased risk of HIV acquisition, preterm birth, and other adverse pregnancy outcomes. However, up to 85% of infected individuals have minimal to no symptoms. Recently, the Centers for Disease Control and Prevention recommended the use of nucleic acid amplification tests (NAAT) to detect Trichomonas vaginalis in both symptomatic and asymptomatic patients.

Xpert TV is classed as a NAAT and designed to run on Cepheid’s molecular diagnostic platform, the GeneXpert system, typically producing results in about an hour. It is the 18th test authorized to run on the GeneXpert system, which also includes the Xpert CT/NG, Xpert Group B Strep, and Xpert HPV.

Dako Earns FDA Approval for Lung Cancer Co-Diagnostic

Dako, an Agilent Technologies company, has received Food and Drug Administration (FDA) approval for a companion diagnostic assay that determines whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to the new treatment Keytruda (pembrolizumab). Dako created the test, known as PD-L1 IHC 22C3 pharmDx, in collaboration with Merck, the developer of Keytruda. An immunotherapy, Keytruda has been approved by FDA as a treatment for patients with metastatic NSCLC whose tumors express programmed death-ligand 1 (PD-L1) as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy.

PD-L1 is thought to play a significant role in inhibiting the immune system. Keytruda works by blocking the interaction between PD-L1 and PD-L2 and the receptor to which they bind, PD-1, which enhances the immune system’s ability to detect and fight cancer cells. Currently, PD-L1 IHC 22C3 pharmDx is the only companion diagnostic that has been validated and approved to identify NSCLC patients eligible for Keytruda treatment.

FDA Clears Additional Flu and RSV Strains for Focus Diagnostics Kit

Focus Diagnostics’ Simplexa Flu A/B & RSV Direct Kit has earned Food and Drug Administration (FDA) clearance for 46 additional influenza A and B virus strains and 7 additional respiratory syncytial virus (RSV) strains. FDA initially cleared the Simplexa test kit for select virus strains in July 2012 and cleared a number of additional strains in 2014. With this most recent clearance, the Simplexa test now detects a total of 92 influenza and RSV virus strains, which is more than any other FDA-cleared molecular test kit, according to the company.

These strains include all four influenza types that the World Health Organization has recommended including in vaccines during the northern hemisphere’s 2015–2016 flu season: A/Switzerland/9715293/2013 (H3N2)-like virus; A/California/7/2009 (H1N1)-like virus; B/Phuket/3073/2013-like virus; and B/Brisbane/60/2008-like virus. In addition, the new strains cleared for the Simplexa kit include 20 avian influenza A and two swine flu virus strains that may be increasingly important to detect as avian and swine flu viruses cross over into human populations.