In This Issue...
Beckman Coulter Receives Clearance for Cardiovascular Disease Assay
The Food and Drug Administration (FDA) has cleared Beckman Coulter's new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems for the diagnosis of myocardial infarction. This follows the June 2013 clearance of the assay on Beckman's Access 2 immunoassay analyzer and means that this test can now be used on all Beckman immunoassay systems, including the UniCel DxC integrated chemistry and immunoassay series. The AccuTnI+3 follows guidelines for contemporary troponin use established by the FDA and uses platform-specific reagents and calibrators.
FDA Clears Luminex Drug Metabolism Test
Luminex Corporation has received FDA clearance for the personalized medicine genotyping assay xTAG CYP2C19 kit. By identifying variants of the P450 2C19 gene that impact patient drug response, this test will help physicians to optimize therapeutic strategy. It analyzes a patient's CYP2C19 genotype using genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples and runs on the Luminex 100/200 or MAGPIX instruments.
NanoString Gets FDA Nod for Breast Cancer Recurrence Assay
FDA has granted 510(k) clearance to NanoString Technologies. for its Prosigna Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company's first FDA-cleared in vitro diagnostic assay, and evaluates a patient's risk of breast cancer recurrence in 10 years. It can be performed using the nCounter Dx Analysis System and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment.
For each patient, the assay calculates the Prosigna Score (also known as the Risk of Recurrence Score) by measuring gene expression levels of RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue. Based on this score and the patient's nodal status, the assay then classifies the patient as being at low, intermediate, or high risk of recurrence. It also automatically generates a personalized full-color patient report. Additionally, the Prosigna features all-in-one assay consumables, including RNA extraction kits, which enable laboratories to perform testing on as little as a single section of FFPE tumor tissue, as well as high-throughput workflow that allows each nCounter Dx Analysis System to process 30 patient samples per day.
Abbott, IntelligentMDx Receive Clearance for Flu, RSV Assay
FDA cleared IntelligentMDx's (IMDx) IMDx Flu A/B and RSV test to run on Abbott's m2000 molecular diagnostics system. This qualitative, reverse transcription PCR assay detects and differentiates between at least 55 different strains and variants of influenza A and B virus, and respiratory syncytial virus (RSV) using nasopharyngeal swabs from patients. Full automation allows it to analyze up to 94 patient samples per run. IMDx developed the test as part of an agreement forged with Abbott in 2011 under which IMDx designs, develops, and manufactures real-time PCR assays for the Abbott m2000 instrument system.