Abbott’s Hand-held Platform Obtains CE Mark

The CE mark has been granted to Abbott’s new i-STAT Alinity system. This hand-held device performs numerous tests using only two to three drops of a person’s blood and delivers results in 2 to 10 minutes. It features a large color touchscreen with graphics-driven guidance, and light and sound notifications that alert clinicians with critical information. Currently, the assay menu includes tests for blood gases and chemistries, electrolytes, and hematology, and Abbott plans to make tests for cardiac markers and coagulation available on the platform at a later date. The device is designed so that in the future it will be possible to add other new tests, such as those for infectious diseases, oncology, or brain injury.

Additionally, the i-STAT Alinity includes connectivity features designed to enable testing virtually anywhere. The device can send data to a healthcare system’s network wirelessly to update results, customize multiple i-STAT Alinity instruments, and manage quality control. 

Foundation Medicine Gets FDA Approval for Ovarian Cancer Co-Diagnostic

The Food and Drug Administration has approved the Foundation Focus CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer for whom Rubraca (rucaparib) treatment could be effective. The test is a tissue-based genomic assay that detects tumor BRCA1 and BRCA2 mutations in ovarian cancer, including both germline and somatic mutations. As a result, it could help to identify more women who could benefit from Rubraca therapy. Conventional testing methods only detect germline mutations and so identify only about half of all BRCA1/2 mutations.

Developed by Clovis Oncology, Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for patients who have advanced ovarian cancer associated with deleterious BRCA mutations and who have been treated with two or more chemotherapies. Foundation worked closely with Clovis to develop FoundationFocus CDxBRCA in parallel with the development of Rubraca, and analyzed tissue samples from individuals with ovarian cancer who enrolled in rucaparib clinical trials to identify biomarkers for the test. 

FDA Clears Integrated Diabetes Management System

LifeScan, part of the Johnson & Johnson Family of Diabetes Cos., has received Food and Drug Administration clearance for the wireless integration of the OneTouch Verio Flex blood glucose monitoring system with WellDoc’s clinically validated diabetes management platform, BlueStar. The OneTouch Verio Flex system transmits blood glucose data wirelessly and automatically to Bluestar using built-in Bluetooth smart technology. WellDoc’s clinical and behavioral engine then provides patients with individualized real-time feedback and virtual coaching based on the patient’s specific treatment plan, while also helping healthcare teams to make timely diabetes management decisions. The OneTouch Verio Flex meter also features ColorSure technology, a color-based indicator designed to make it easier for patients to understand blood glucose test results when self-monitoring. Along with the OneTouch Reveal app, which sends blood glucose readings wirelessly to a patient’s mobile device, this system seeks to create a comprehensive, data-driven, and payer-reimbursed program for managing type 2 diabetes. LifeScan and WellDoc are now working with health plans to help provide patient access for this integrated system. 

FDA OKs Instrumentation Laboratory’s Critical Care Testing System

Instrumentation Laboratory has received 510(k) clearance from the Food and Drug Administration for the GEM Premier 5000 analyzer with Intelligent Quality Management 2 (iQM2). Designed for use in hospitals at the point-of-care, this system measures critical care parameters such as blood gases, electrolytes, metabolites, and a full CO-oximetry panel, and provides results in seconds from heparinized whole blood samples. IQM2 also gives a real-time picture of quality for each sample. With a continuous cycle of five quality checks, iQM2 performs quality checks before and after every sample, while also providing immediate correction and automatic documentation of any action it performs. Using IntraSpect technology, samples are checked during analysis, too. Additionally, the new data manager GEMweb Plus 500 Custom Connectivity will be introduced on GEM Premier 5000 analyzers. This will connect all GEM Premier analyzers in a system, including GEM Premier 4000, for centralized oversight of instruments, operators, and data from any location. 

LifeCodexx Earns CE Mark for Epigenetic, qPCR-based NIPT Software

The CE mark has been granted to the Germany-based company LifeCodexx for its PrenaTest BioIT analysis software, which is based on a methylation-specific quantitative PCR (qPCR) assay for detecting fetal trisomy 21 (qNIPT). The proprietary PrenaTest software can now be used to analyze data from next-generation sequencing (NGS) as well as from qPCR. A prospective clinical study with more than 2,200 patients confirmed that NGS-based PrenaTest is 100% accurate for fetal trisomy 21. Another recent blinded prospective validation study with close to 1,000 samples also demonstrated 100% concordance between results obtained from NGS-based PrenaTest and qNIPT, the latter of which was developed and validated with around 2,500 maternal blood samples. Moreover, the new performance evaluation demonstrated that qNIPT provides reliable results from blood samples with a fetal fraction as low as 2.4%. Currently, the PrenaTest is available in more than 35 countries worldwide and is performed locally at four sites in Germany and Switzerland. 

NY State Grants Conditional Approval to Pre-Implantation Genetic Screening Test

CombiMatrix, a company that specializes in DNA-based reproductive health and pediatric testing services, has received conditional approval from the New York State Department of Health for the CombiPGS test, a pre-implantation genetic screening test that uses next-generation sequencing. The CombiPGS test is for women undergoing in vitro fertilization and aims to maximize the chance of successful implantation and pregnancy by screening embryos for chromosomal abnormalities prior to implantation of the embryo. Using Illumina’s 24sure BAC array comparative genomic hybridization, the CombiPGS performs chromosomal microarray analysis on one to several cells biopsied from an embryo to identify chromosome aneuploidies as well as some types of segmental aneuploidies. To minimize the risk of an error, CombiMatrix also employs individual bar-coding of embryos and numerous sample tracking and control procedures. However, the CombiPGS is not designed to detect polyploidy, balanced chromosomal rearrangements, or alterations that are smaller than 20 Mb, including very small insertions, deletions, or point mutations that cause single gene disorders.