Inova Diagnostics has received Food and Drug Administration clearance for Quanta Flash HMGCR, a test that aids in the diagnosis of idiopathic inflammatory myopathy (IIM). IIM is a group of conditions that affect the skeletal muscles, resulting in progressive muscle weakness and in some cases leading to tissue necrosis and disability. In some instances, IIM develops in patients taking statins to lower blood cholesterol. Inova’s test detects autoantibodies to the enzyme 3-hydroxy-3 methylglutaryl-coenzyme A reductase (HMGCR). These antibodies are a biomarker for IIM and also associated with statin exposure. The test is designed to run on the Bio-Flash instrument, a random access chemiluminescent system. By detecting HMGCR antibodies, the assay is designed to help differentiate between patients on statins with self-limited myopathy who will recover after statin discontinuation and those with progressive disease who are at risk of severe morbidity and often require aggressive immunosuppressive therapy.

FDA Issues Alert About Risks Associated With Rupture of Membranes Tests

The Food and Drug Administration (FDA) has issued a letter to healthcare providers about the serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman’s water has broken—also known as a rupture of the membranes (ROM). The letter reminds providers that the labeling for these tests specifies that they should not be used on their own to independently diagnose a ROM, and that FDA has only cleared these tests for use in conjunction with other clinical assessments. The agency decided to send this letter after an ongoing assessment of medical device reports revealed adverse events related to the use of ROM tests, including 13 fetal deaths and multiple reports of health complications in pregnant women. This information indicates that healthcare providers may be relying solely on ROM tests when making critical patient management decisions, which could increase the risk of fetal harm or death.

FDA has also separately notified the public of a voluntary recall for one brand of these tests, Qiagen’s AmniSure ROM test strips, which were distributed between October 2017 and March 2018. These devices do not exhibit a control line, making it potentially difficult for healthcare providers to interpret results. This recall is unrelated to the improper use of the tests, however, and FDA is not aware of device malfunctions associated with ROM tests made by other manufacturers.

FDA Approves Roche Companion Diagnostic for Lung Cancer Therapy

Roche has received Food and Drug Administration (FDA) approval for the cobas EGFR Mutation Test v2 to be used as a companion diagnostic test for the lung cancer treatment Iressa. Iressa (gefitinib) is a targeted monotherapy for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that is positive for epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. The cobas EGFR Mutation Test v2 uses real-time polymerase chain reaction (PCR) to qualitatively detect 42 defined mutations of the EGFR gene in exons 18-21—including L858R, exon 19 deletions, and T790 mutations—in order to identify patients who are most likely to respond to treatment with Iressa. It is the first FDA-approved EGFR test to include both tissue and liquid biopsy (plasma) as specimen types for testing. The test is performed on the cobas 4800 system, which offers PCR amplification and detection coupled with software that automates result interpretation and reporting.

Grifols Gets FDA Nod for Zika Virus Assay

The Food and Drug Administration (FDA) has approved Grifols’ Procleix Zika Virus assay for the detection of the virus in individual or pooled plasma specimens from human donors, including from volunteer donors of whole blood and blood components for transfusion. Grifols’ assay is also approved for testing plasma or serum specimens in order to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors, as well as human cells, tissues, and cellular and tissue-based products. The assay is performed on the Procleix Panther system automated platform using nucleic acid technology, and is designed to enable blood banks and donor centers to enhance the safety of their blood supplies. It has been in use since June 2016 under an FDA Investigational New Drug protocol to screen donated blood collected in the U.S. In 2016, the Procleix Zika Virus assay was also CE-marked for use in European countries.

Illumina Receives Approval From China for Benchtop NGS System

The China Food and Drug Administration (CFDA) has approved Illumina’s MiSeqDx Sequencing system, making this Illumina’s first CFDA-cleared, next-generation sequencing system in China. A benchtop sequencer designed specifically for clinical laboratories, the MiSeqDx system uses Illumina’s sequencing by synthesis chemistry and includes integrated software that enables run setup, sample tracking, user management, audit trails, and data interpretation. The system is designed for use with a menu of in vitro diagnostic (IVD) assays and also as an open platform for the development of custom IVD tests. MiSeqDx features an automated workflow that starts by extracting genomic DNA from peripheral whole blood specimens or formalin-fixed paraffin embedded tissues. These DNA samples are then used to generate indexed libraries, which are sequenced with a ready-to-use, prefilled, MiSeqDx reagent cartridge.

In addition to China, the MiSeqDx Sequencing system now has regulatory approval in the U.S., Canada, Argentina, European countries recognizing the CE mark, Australia, South Korea, Thailand, and the Philippines.

China FDA OKs Novogene Lung Cancer Co-Diagnostic

Tianjin Novogene Bioinformatics Technology Company, a fully-owned subsidiary of Novogene, has received China Food and Drug Administration (CFDA) approval for its NovoFocus NSCLC CDx test. The NovoFocus uses next-generation sequencing (NGS) to simultaneously analyze tumor samples for multiple genomic mutations associated with the efficacy of several CFDA-approved targeted therapies for non-small cell lung cancer (NSCLC). The NovoFocus was developed on the Thermo Fisher Ion Proton sequencing platform, while the reagent kits for sample processing and library construction, as well as the data analysis and result reporting software system, were developed by Novogene. Following this CFDA approval, healthcare professionals can use results from the test’s sequencing and analysis of three genes, EGFR, ALK, and ROS1, to identify NSCLC patients who might be eligible for treatment with Iressa (gefitinib), Tagrisso (osimertinib), and Xalkori (crizotinib), respectively. The test also provides mutation analyses for three other oncogenes, KRAS, BRAF, and PIK3CA, which can be used with other test results and a patient’s disease characteristics to guide clinical decisions.