We’ve had a little hiatus over here at the Week In Genomics, due largely to a little shindig that we call the Festival of Genomics California! Do check out our live blog of the event if you missed any of the action. We had a fantastic week in San Mateo and are very excited about the Festival of Genomics London, coming soon at the end of January 2016!

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Right, round-up time! This week discussions about FDA regulation have been rattling around the FLG office, Genomics England made an exciting announcement, and members of the Hinxton Group published a map through the ethical thicket of CRISPR. What are your highlights of the week?

Will leukaemia success open the door for gene-editing therapies?

Gene editing has dominated the news over the past few weeks, catching the imagination of the scientific and business communities, and igniting the public imagination. We heard at MIT EmTech that Editas Medicine want to start testing a therapy for inherited blindness in 2017; RetroSense Therapeutics‘ Series B funding round closed at $6m for a treatment for retinitis pigmentosa; and just last week  doctors at Great Ormond Street Hospital successfully treated a baby girl’s aggressive leukaemia using a gene-editing therapy. Is this simply a one-off success, or has the door been opened to gene-editing medicine?

QIAGEN release GeneReader to simplify clinical diagnostic use of NGS

QIAGEN’s new GeneReader NGS System unveiled at Association for Molecular Pathology 2015 Annual Meeting. Next generation sequencing is becoming an increasingly crowded marketplace, with a range of companies looking to carve out a meaningful niche in the space not occupied by Illumina. While QIAGEN’s latest offering is something of a late entry to the space, the company are hoping that the GeneReader platform will make NGS-based diagnostics a reality for hospital labs.

US FDA cracks down on direct-to-consumer tests

The FDA is beginning a crack down on companies selling genetic tests without the proper approval. DNA4Life and Interleukin Genetics are among the companies experiencing push back from the regulator, who sent a similar warning to Pathway Genomics over the marketing of a liquid biopsy DNA test in September.

Genomics England announce Clinical Interpretation Partner for 100,000 Genomes

WuXi NextCODE’s analysis platform continues to be in high demand among large-scale genome projects. Today Genomics England have announced that the company has been contracted as a Clinical Interpretation Partner for the 100,000 Genomes Project, taking charge of data interpretation for cancer and rare disease samples.

CRISPR: A path through the thicket

As various advisory bodies, scientific organizations and funding agencies deliberate on genome editing in humans, Hinxton Group members Debra J. H. Mathews, Robin Lovell-Badge and colleagues lay out some key points for consideration in this week’s Nature.

  • Should genome editing be allowed in basic research involving human sperm, eggs and embryos?
  • Should only embryos left over from in vitro fertilization be used in genome-editing research or may embryos be specifically created for research
  • What safety and efficacy thresholds need to be met before the use of genome editing in human reproductive applications could be considered?
  • If such thresholds are met, what uses for genome editing in human reproductive applications might be permissible?

Can CRISPR avoid the Monsanto problem?

“It is distressing, but a fact, that the more rapidly any technology is adopted by scientists the more likely it is to leave people confused, anxious, and suspicious,” writes Michael Specter for the New Yorker. When Monsanto introduced GMOs in the late 90s they completely failed to engage with the public, creating enormous mistrust around genetic technology and corporate involvement that persists to this day. Michael argues that CRISPR is simply too important to become “entangled in the same web of confusion that has made GMOs such a toxic issue.”