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In Brief This Week: FDA, PreventionGenetics, Twist Bioscience, and More

NEW YORK (GenomeWeb) – 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.

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.

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. The Little Zebra Fund, which was founded by two physicians specializing in rare disease diagnostics, offers financial assistance to qualified patients for genetic testing.

Twist Bioscience announced this week that it has implemented Battelle's ThreatSeq web service in order to enhance its biosecurity efforts. ThreatSeq screens DNA sequences and makes use of a biocuration pipeline to automatically review results and identify potential sequences of concern. Battelle said it has built up a large database of sequences of concern through its years of characterizing biothreats and has developed an algorithm to screen DNA production at scale rapidly.

Immunovia announced this week that researchers at the Institute for Liver and Digestive Health at University College London will expand the prospective collection of blood samples to support the continuation of the company's PanSYM-1 pilot 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. UCL is the latest member of PanFAM-1, Immunovia's study of familial/hereditary high-risk groups of pancreatic cancer.

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, this material will be sent to about 30 labs as part of the first-ever EQA program for clinical labs that are monitoring TMB as part of their cancer tumor profiling assays by next-generation sequencing, SeraCare said.

Netherlands-based DDL Diagnostic Laboratory said this week it 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.

GenScript announced this week that it has launched a public beta testing program for its new Precision Mutant Library Services for the drug development, industrial chemical, and synthetic biology markets. The new services, which utilize semiconductor-based oligonucleotide synthesis technology, allow for defined distribution of each codon, resulting in a diverse library containing complete coverage of only the desired mutant variants, GenScript said. The beta-testing program offers significantly reduced pricing per library and NGS analysis, in exchange for feedback on the service and library performance, the company added. More information may be found here.

Genetic Technologies said this week that 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 said it can also take advantage of tax benefits, subsidies, and facilitated investment. HSRC is owned by China Electronics Corporate, a state-owned enterprise of China's central government.

Syapse said this week that its Syapse Oncology platform has been certified as compliant for information security by the Health Information Trust Alliance (HITRUST). The HITRUST certification tests software against common healthcare-specific security, privacy, and regulatory requirements, including HIPAA, ISO, NIST, and Control Objectives for Information and Related Technologies specifications.

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