---
title: Gene Editing Safety Resources | LockSeq by Countagen
description: Guides, regulatory summaries and validation data for off-target confirmation. FDA April 2026 guidance, NIST benchmarking, LockSeq technical overview.
---

[![Logo\_horizontal\_colored logo with black text](https://www.countagen.com/hubfs/Logo_horizontal_colored%20logo%20with%20black%20text.png)](https://www.countagen.com/?hsLang=en)

- [Technology](https://www.countagen.com/technology?hsLang=en)
- [Bioinformatics](https://www.countagen.com/bioinformatics?hsLang=en)
- [Sample Report](https://www.countagen.com/lockseq-sample-report?hsLang=en)
- [Resources](https://www.countagen.com/resources)
- [FAQ](https://www.countagen.com/faq?hsLang=en)
- [About Us](https://www.countagen.com/about-us?hsLang=en)

[Request a quote](https://www.countagen.com/contact?hsLang=en)

Resources

# Data, guidance and documents for off‑target confirmation

See what a LockSeq report looks like, read what FDA's draft guidance, EMA's guidelines and China's new rules mean for your program, and download our latest posters and talks.

[Sample report](https://www.countagen.com/resources#featured)[Regulatory guidance](https://www.countagen.com/resources#featured)[Posters & talks](https://www.countagen.com/resources#downloads)

LockSeq report · resultsIllustrative data

| Site | Edited | Control | Call |
| --- | --- | --- | --- |
| DP-001 | 71.3% | 0.00% | Edited |
| DP-187 | 0.23% | 0.00% | Edited |
| DP-004 | 0.00% | 0.00% | No variant |

Sample report · 2 min video

## See exactly what you get back from a LockSeq project

An interactive report built from demo data: variant frequencies per site, comparison with your control, coverage filters and read-level detail, plus a short video walkthrough.

[View the sample report](https://www.countagen.com/lockseq-sample-report?hsLang=en)

FDA · Draft guidanceApril 2026

| Guidance step | Status |
| --- | --- |
| Draft announced | Apr 15, 2026 |
| Comment period | Closed Jul 14 |
| Final guidance | Pending |

Regulatory explainer · Sep 2026

## What the FDA's April 2026 draft guidance means for off‑target confirmation

What the draft asks for at the confirmation step, what that means in practice, and why off-target studies now come before the IND.

[Read our summary](https://www.countagen.com/countagen-insights/fda-april-2026-guidance-off-target-confirmation?hsLang=en)[FDA guidance ↗](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-assessment-genome-editing-human-gene-therapy-products-using-next-generation-sequencing)

China · CGT rules2026

| Rule | In force |
| --- | --- |
| Order 818 · hospital route | May 1, 2026 |
| Order 828 · drug route | May 15, 2026 |
| CDE cell therapy scope | Jul 2026 |

Regulatory explainer · Oct 2026

## China's new rules for cell and gene therapy: what changed in 2026

Orders 818 and 828, where gene-edited cells sit, what the guidance asks for on off-target editing, and the rules for samples and data leaving China.

[Read the explainer](https://www.countagen.com/countagen-insights/chinas-new-rules-for-cell-and-gene-therapy-what-changed-in-2026?hsLang=en)

EU · EMA guidance2021–2026

| Text | Effective |
| --- | --- |
| GM-cells guideline, Rev. 1 | Jun 1, 2021 |
| Clinical trials guideline | Jul 1, 2025 |
| New gene editing guidance | Drafting 2026 |

Regulatory explainer · Oct 2026

## Gene-edited therapies in the EU: what EMA asks for on off-target editing

EMA's two guidelines on off-target work, one authorized example, the hospital exemption, the pending pharma package and GDPR.

[Read the explainer](https://www.countagen.com/countagen-insights/ema-off-target-requirements-gene-edited-therapies?hsLang=en)

Off-target · 4 documentsOct 2026

| Document | WGS for off-target |
| --- | --- |
| FDA draft | Not at confirmation |
| EMA guidelines | Not named |
| CDE · drug route | Should include |
| Order 818 · hospital route | In vivo editing only |

Regulatory comparison · Oct 2026

## Off-target studies: FDA, the EU and China

Four documents side by side, section by section: where they agree on off-target work, where they differ, and where whole-genome sequencing comes in.

[Read the comparison](https://www.countagen.com/countagen-insights/fda-vs-china-cde-off-target-studies?hsLang=en)

Posters, talks & documents

## Downloads

Our latest conference poster and talk, plus the LockSeq service overview.

[Poster · FASEB Genome Engineering 2026High-fidelity NGS confirmation of gene-editing outcomesNIST reference-standard validation on Illumina and Nanopore, UMI-consensus calling, and results across five off‑target panels.Download PDF ↓](https://2fty0g.share-eu1.hsforms.com/26WOVGLmjRNyIN-7DRwCTsQ)[Talk · ICGT 2026, ParisGenomic safety in gene therapies through high-fidelity NGS validationTen-minute talk: why off‑target confirmation matters for safety assessment, how LockSeq works, and cross-platform validation.Download slides ↓](https://2fty0g.share-eu1.hsforms.com/2y-cG-qCET-OWpodCeKlpvw)[FlyerLockSeq service overviewOne page: the three-step workflow, what's in the report and turnaround from DNA to results.Download PDF ↓](https://www.countagen.com/hubfs/LockSeq-Service-Flyer-2026-10-22-v2.pdf?hsLang=en)

## Have a question about your panel?

Send us your nominated sites and sample count. Most projects are scoped within 24 hours.

[Request a quote](https://www.countagen.com/contact?hsLang=en)[info@countagen.com](mailto:info@countagen.com)

[![Countagen\_Logo\_White](https://www.countagen.com/hubfs/Logo_horizontal_colored%20logo%20with%20white%20text.png)](https://www.countagen.com?hsLang=en)

| Countagen AB Nobels väg 16 171 65 Solna Sweden | Registered supplier on [Scientist.com](https://app.scientist.com/providers/countagen-ab) [![Scientist.com](https://www.countagen.com/hs-fs/hubfs/Scientist-com.png?width=1244&height=259&name=Scientist-com.png)](https://app.scientist.com/providers/countagen-ab) |
| --- | --- |

<https://www.linkedin.com/company/countagen/>

### LockSeq

- [Overview](https://www.countagen.com?hsLang=en)
- [Technology](https://www.countagen.com/technology?hsLang=en)
- [Bioinformatics](https://www.countagen.com/bioinformatics?hsLang=en)
- [Sample report](https://www.countagen.com/lockseq-sample-report?hsLang=en)

### Resources

- [Resources](https://www.countagen.com/resources)
- [FAQ](https://www.countagen.com/faq?hsLang=en)

### Company

- [About us](https://www.countagen.com/about-us?hsLang=en)
- [Contact](https://www.countagen.com/contact?hsLang=en)

© 2026 Countagen AB All rights reserved [Terms of Use](https://www.countagen.com/terms-of-use?hsLang=en) [Privacy Policy](https://www.countagen.com/privacy-policy?hsLang=en) [Cookie Policy](https://www.countagen.com/cookie-policy?hsLang=en) [Service Terms & DPA](https://www.countagen.com/legal?hsLang=en)

[Powered by Atlas - a B2B SaaS HubSpot theme](https://www.kalungi.com/atlas-hubspot-theme-for-b2b-saas-software)