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In Brief This Week: Exosome Diagnostics, Illumina, Premaitha Health, and More

NEW YORK (360Dx) – Exosome Diagnostics said that the national Medicare reimbursement price for its ExoDx Prostate IntelliScore (EPI) test has been set by the US Centers for Medicare and Medicaid Services at $760. The test has been added to the 2018 Clinical Laboratory Fee schedule, effective Jan. 1, 2018, the firm added.

EPI is a urine-based test that looks for three exosomal RNA biomarkers expressed in men with high-grade prostate cancer to help in the biopsy decision-making process.

Illumina has opened a commercial and customer training center in France. Its Solutions Center, which is located within a biocluster hub near Paris called Genopole Campus, will provide education and training in genomics technologies for up to 1,000 scientists per year. The center will also host Illumina's first commercial office in Europe and will provide scientists with access to Illumina's entire network of facilities.

Premaitha Health said this week that it has signed an agreement with a new laboratory partner to offer a NIPT screening solution in a new East Asian territory for Premaitha. The company did not name the partner or the territory, but said the partner is a private reference laboratory, which will provide the NIPT screening solution to its network of hospitals and clinics in the region. The installation of the laboratory is set to be completed in H1 2018. Premaitha also said this week that it has signed partnerships with four new laboratories in the Middle East to offer its Iona NIPT test in that region. Two of the laboratories will be installed before the end of 2017 and the other two will become operational in Q1 2018.  

Gradientech said this week that it has received ISO 13485 certification, demonstrating an implemented quality management system that ensures high quality and consistent design, development, manufacturing, support, and sale of microfluidic-based products for the determination of cell responses to concentration gradients and that are safe for their intended purpose. The firm said the certification is an important step towards its goal of CE marking its in vitro diagnostic system, QuickMICTM, for ultra-rapid antibiotic susceptibility testing.

Pillar Biosciences said this week that it received ISO 13485:2016 certification for design, development, manufacture, and distribution of products for the clinical oncology laboratory within a comprehensive quality management system. The firm said that the first Pillar Biosciences assay produced under this QMS is the recently-launched Onco/Reveal BRCA 1/2 panel targeting the coding region of the BRCA genes. It noted that while current products are for research use only, Pillar intends to file selected targeted NGS panels with proven clinical utility for regulatory approval.

Quest Diagnostics' board of directors has declared a quarterly cash dividend of $.45 per share, payable on Jan. 24, 2018 to shareholders of record of the company's common stock on Jan. 9, 2018.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the 360Dx site.