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In Brief This Week: FDA, SeraCare, Immunovia, And More

NEW YORK (360Dx) – The FDA this week warned against the use of pre-owned test strips, as well as test strips not authorized for sale in the US, saying they may lead to inaccurate test results or potentially serious infection. The agency noted that some sellers are marketing pre-owned test strips — those previously owned by someone else — and unauthorized test strips are being marketed in the US to consumers often through online marketplaces or directly from the seller.

SeraCare Life Sciences recently announced that it has become a technology partner for the first-ever tumor mutational burden (TMB) external quality assessment (EQA) program being developed by the International Quality Network for Pathology. In its role for the project, SeraCare will develop, manufacture, and supply a range of highly-characterized cell line genomic DNA and formalin-fixed, paraffin embedded standards with confirmed low, mid, and high levels of mutational burden within their exome regions. Starting in June 2019, this material will be sent to about 30 labs as part of the first-ever EQA program for clinical labs who are monitoring TMB as part of their cancer tumor profiling assays by next-generation sequencing, said SeraCare.

Immunovia announced this week that researchers at the Institute for Liver and Digestive Health, University College London will expand the prospective collection of blood samples for the company's PanSYM-1 pilot study to support the continuation of the study into the prospective validation stage. The study's goal is to demonstrate the diagnostic value of the firm's IMMray PanCan-d blood-based test for detecting pancreatic ductal adenocarcinoma earlier than with current standards. The pilot PanSYM-1 study at UCL began in 2017 and is scheduled for readout this year. Through the UCL collaboration, PanSYM-1, which aims to collect 2,000 single samples, will be expanded to include "the active network of rapid diagnostic and assessment centers throughout the UK," Immunovia said. It added that UCL, one of the UK's major screening centers for familial/hereditary pancreatic cancer, is the latest member of PanFAM-1, Immunovia's study of familial/hereditary high-risk groups of pancreatic cancer.

The FDA announced this week that it has updated the expiration date on its guidance for industry pharmacogenomic data submissions. The guidance, which was originally issued in March 2005, is intended to facilitate progress in pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development. It was slated to expire in March, but the expiration date has been updated to Sept. 30, 2020.

Genetic Technologies said this week it has created its Asian operations within the Hainan Resort Software Community Free Trade Zone in China. As part of HRSC, Genetic Technologies will receive help in securing Chinese regulatory approval of its genetic risk assessment tests. The company can also take advantage of tax benefits, subsidies, and facilitated investment, it said. HSRC is owned by China Electronics Corporate, a state-owned enterprise of China's central government.

PreventionGenetics said this week that it has partnered with the Little Zebra Fund to provide clinical genetic testing for patients in the San Francisco Bay Area. Little Zebra Fund, which was founded by two physicians specializing in rare disease diagnostics, offers financial assistance to qualified patients for genetic testing.

Netherlands-based DDL Diagnostic Laboratory will migrate its bioinformatics pipeline to the Seven Bridges Complete Bioinformatics Ecosystem in hopes of increasing its microbiome and virology analysis capacity. DDL said that the move will allow the lab to offer customized pipelines, faster analysis, and better scalability.

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