regulatory roundupFirst CE Mark Granted to Liquid Biopsy Lung Cancer Co-Diagnostic 

Qiagen has received the CE mark for its liquid biopsy-based companion diagnostic for lung cancer, the therascreen EGFR RGQ Plasma PCR kit. Co-developed by Qiagen and AstraZeneca, this test analyzes circulating tumor DNA to identify advanced non-small cell lung cancer patients who could benefit from treatment with the drug Iressa (gefitinib) when a suitable tumor sample is not available. The launch of this kit coincides with the European Medicines Agency extending the drug label of Iressa to include the detection of oncogenic EGFR mutations in circulating tumor DNA obtained from a blood sample as a way to determine whether Iressa will be effective in a patient. Receipt of the CE Mark, which applies to more than 30 European countries, makes the therascreen EGFR RGQ Plasma PCR kit the first-ever regulated companion diagnostic assay that has demonstrated clinical utility for guiding treatment decisions in patients with solid tumors based on the analysis of molecular biomarkers obtained from a body fluid.

Roche Gets FDA Approval for Blood Screening Test, Emergency Use Authorization for Ebola Test

The Food and Drug Administration (FDA) recently approved one of Roche’s infectious diseases tests and gave emergency use authorization for another. FDA approved the cobas TaqScreen MPX test, v2.0 for the detection and identification of HIV, hepatitis C virus (HCV), and hepatitis B virus (HBV) in donations of human whole blood and blood components, including source plasma. Specifically, the test uses real-time, multi-dye PCR to qualitatively detect RNA from HIV-1 groups M and O, HIV-2, and HCV, as well as DNA from HBV. It runs on the fully automated cobas s 201 system, which enables signal detection in four separate channels, facilitating simultaneous monitoring of the three viral targets. The cobas TaqScreen MPX is the only FDA-approved test to detect and identify HIV, HCV, and HBV simultaneously in one ready-to-use assay.

FDA has also provided an emergency use authorization for Roche’s LightMix Ebola Zaire rRT-PCR test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as travel to and from West Africa. Manufactured by TIB MOLBIOL GmbH and distributed exclusively by Roche, the test is a one-tube duplex assay that qualitatively detects Ebola Zaire virus in whole blood samples using the large installed base of Roche’s LightCycler 480 or cobas z 480 instruments. It also simultaneously detects an endogenous human house-keeping gene that is used as an internal control.

Alere i Influenza A & B Becomes First CLIA-Waived Nucleic Acid-Based Flu Test

FDA has granted the first CLIA waiver to a nucleic acid-based flu test, the Alere i Influenza A & B, which will allow this test to be used in a broad variety of non-traditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other healthcare facilities. FDA first cleared the Alere i Influenza A & B test in June 2014 as a prescription-only device to detect influenza A and B viral RNA in nasal swab samples and categorized it under CLIA as moderate complexity. The agency decided to change this categorization after Alere submitted data demonstrating the test’s ease of use and low risk of false results when used by untrained operators.

The Alere i Influenza A & B test is a point-of-care test that provides results in as little as 15 minutes. The test is intended to aid in diagnosis along with the evaluation of other risk factors; negative results do not rule out influenza virus infection.

First Newborn Screening Test for Severe Combined Immuno-deficiency Gets FDA OK

FDA has granted a de novo classification to PerkinElmer’s EnLite Neonatal TREC kit, making it the first screening test for severe combined immunodeficiency (SCID) in newborns that FDA has permitted to be marketed. SCID is a group of disorders caused by defects in genes involved in the development and function of T-cells and other infection-fighting immune cells.

Infants with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early detection and treatment, death can occur within the infant’s first year, but with early intervention, survival can improve markedly. The Secretary of the U.S. Department of Health and Human Services and the Advisory Committee on Heritable Disorders in Newborns and Children recommend that every state screen newborn infants for SCID. The EnLite Neonatal TREC kit could help states fulfill this recommendation by enabling states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels.

Using a dried blood spot sample, the EnLite kit helps detect SCID by determining whether a certain type of DNA, known as T-cell receptor excision circles (TREC DNA), is low or missing from the newborn’s blood. Newborns with SCID typically have zero or low amounts of TREC DNA compared to healthy infants.

FDA’s review of the EnLite Neonatal TREC kit included a clinical study of approximately 6,400 blood spot specimens from routine screening of newborns, 17 of which had confirmed SCID diagnosis. The EnLite kit correctly identified all 17 SCID cases. After receiving a positive EnLite result, however, additional confirmatory testing is still required to obtain a SCID diagnosis.

FDA Clears Beckman Coulter’s Vitamin D Test

Beckman Coulter has received 510(k) clearance from FDA for the Access 25(OH) Vitamin D Total assay, which is available for use on the company’s Access 2 and UniCel DxI series of immunoassay systems. This new assay is traceable to the gold standard 25(OH) vitamin D reference measurement procedure (RMP) from Ghent University and provides equimolar detection of 25(OH) vitamin D2 and 25(OH) vitamin D3. The Ghent RMP is the reference procedure used by the Vitamin D Standardization Program, an international collaboration established by the Office of Dietary Supplements at the National Institutes of Health with the goal of promoting standardized laboratory measurements of 25(OH) vitamin D around the world. Beckman’s vitamin D assay is also designed to provide stability and facilitate storage through packaging that prevents light-induced reagent degradation.