Technology · Health & biomedicine / Diagnostics & medtech
CRISPR diagnostics
Cas-enzyme nucleic-acid detection — point-of-care molecular diagnostics from sample to lateral-flow readout.
1 · What it gives
CRISPR diagnostics use the collateral cleavage of Cas12/Cas13 enzymes to detect nucleic acids at attomolar sensitivity (2 aM) in <30 min, enabling decentralized testing without thermocyclers.
Key directions:
- SHERLOCK (Cas13 RNA detection): RNA targets via collateral cleavage.
- DETECTR (Cas12 DNA detection): DNA targets with reporter readout.
- Isothermal coupling (RPA/LAMP front-end): amplification at constant temperature.
- Lateral-flow readout (paper-strip output): instrument-free visual result.
Sectoral value chain#
[sample] ──> [extraction] ──> [amplification] ──> [Cas detection]
│
(collateral cleavage)
│
▼
[result] <─── [lateral flow] <────┘
Value chain levels#
| Level | Description | Key inputs/outputs |
|---|---|---|
| Sample Prep | lysis and extraction | In: swab. Out: nucleic acids. |
| Amplification | isothermal RPA/LAMP | In: primers. Out: amplicons. |
| Cas Reaction | guided cleavage | In: gRNA, Cas. Out: signal. |
| Readout | lateral flow / fluor | In: reporter. Out: result. |
| Interpretation | call positive/negative | In: signal. Out: report. |
| Reporting | data capture | In: report. Out: record. |
Cross-cutting technologies:
- Guide-RNA design (gRNA Design): target-specific guide libraries.
- Reporter chemistry (Reporter Chemistry): fluorescent/colorimetric readouts.
- Microfluidic cartridges (Microfluidics): integrated single-use cartridges.
2 · What it replaces 2 · matched by industry
| D2E4 | Crop disease forecasting models, spore traps, pheromone and smart pest traps and field diagnostics — spray when risk is real instead of calendar-based fungicide and insecticide programmes Replaces: Fixed-interval ("calendar") protective fungicide sprays and routine insecticide applications regardless of pest pressure | EAC |
| D2E– | On-farm culture, PCR panels, rapid tests and veterinary laboratory services for livestock and aquaculture — treat what is diagnosed instead of blanket and prophylactic antibiotic treatment Replaces: Blanket treatment of every clinical mastitis case, group metaphylaxis on suspicion, prophylactic antibiotics in hatcheries and ponds, … | DIAG |
3 · How to implement 6 steps
- 1Sample lysisA 200 µL swab is lysed to release nucleic acids within 5 min.
- 2Isothermal amplificationRPA/LAMP amplifies targets at 37–42 °C in 10 min.
- 3Cas/gRNA reactionGuide RNA directs Cas to the target sequence, detecting down to 10 copies per reaction.
- 4Reporter cleavageCollateral cleavage activates over 1000 reporter molecules per target.
- 5Lateral-flow readoutA paper strip shows a visual positive/negative line in 5 min.
- 6Result reportingThe result is captured to the patient record at about 0.61 USD per test.
4 · Who delivers
Matched suppliers (matched automatically)
| Vaxxinova Norway | Norway | Not classified | active |
| Pairwise | United States | Research / RTO | active |
| Amano Enzyme | Japan | Producer | active |
| Codexis | United States | Producer | active |
| Hipra | Spain | Producer | active |
| KLK OLEO | Malaysia | Research / RTO | active |
| EW Group | Germany | Producer | active |
In the services and supply catalogue 4 · paid service
Analytical & testing services · Laboratory & analytical instruments · Reagents & kits · Regulatory & certification
Leading companies and institutes (from the brief)
| Company / Institute | Country | Key products / platforms | Tech features | Status 2026 |
|---|---|---|---|---|
| Mammoth Biosciences | 🇺🇸 USA | DETECTR | Cas12/Cas14 | Commercial |
| Sherlock Biosciences | 🇺🇸 USA | SHERLOCK | Cas13 RNA | Commercial |
| Caspr Biotech | 🇺🇸 USA | Portable Cas | field assays | Growth |
| Tolo Biotech | 🇨🇳 China | CRISPR Kits | scaled mfg | Commercial |
| Qiagen | 🇩🇪 Germany | IVD Reagents | CE-IVD | Commercial |
| BGI | 🇨🇳 China | Assay + Seq | integration | Commercial |
5 · Rules & route to market
Route into Russia / EAEU: EAC · EAEU accredited bodies / Rosakkreditatsiya
declaration registered within 3 working days (testing extra); certification longer
Information, not legal advice — confirm the procedure for your product. (2026-10-06)
declaration registered within 3 working days (testing extra); certification longer
Information, not legal advice — confirm the procedure for your product. (2026-10-06)
United States
The US leads on EUA-grade point-of-care platforms.
point-of-care, emergency use, platform companies#
- Mammoth Biosciences: DETECTR-based platforms.
- Sherlock Biosciences: SHERLOCK CRISPR diagnostics.
- FDA EUA pathway: emergency authorization for rapid tests.
European Union
The EU operates under IVDR with notified-body conformity.
IVDR conformity, notified bodies, CE-IVD#
- Qiagen: assay reagents and platforms.
- IVDR 2017/746: in-vitro diagnostic regulation.
- CE-IVD marking: conformity for market access.
China
China scales manufacturing and domestic NMPA approvals.
scale manufacturing, domestic approval, export#
- Tolo Biotech: CRISPR detection kits.
- BGI: sequencing and assay integration.
- NMPA fast-track: domestic IVD approval.
6 · Money: tenders & grants
| Tender | Greece – Biochemical analysers – ΗΛΕΚΤΡΟΝΙΚΟΣ ΑΝΟΙΚΤΟΣ ΔΙΑΓΩΝΙΣΜΟΣ ΑΝΩ ΤΩΝ ΟΡΙΩΝ ΣΕ ΕΥΡΩ ΓΙΑ ΤΗΝ ΠΡΟΜΗΘΕΙΑ … ΓΕΝΙΚΟ ΑΝΤΙΚΑΡΚΙΝΙΚΟ ΟΓΚΟΛΟΓΙΚΟ ΝΟΣΟΚΟΜΕΙΟ ΑΘΗΝΩΝ "Ο ΑΓΙΟΣ ΣΑΒΒΑΣ" · Greece | Dec 11, 2026 56 days |
| Tender | Netherlands – Blood-testing reagents – Gevalideerde Totaaloplossing voor de hielprikscreening op … Rijksinstituut voor Volksgezondheid en Milieu (RIVM) · Netherlands | Nov 10, 2026 25 days |
7 · Tech stack & innovations
The stack couples amplification, guided cleavage and a simple readout.
- Isothermal amplification (RPA/LAMP):
- constant-temperature amplification without thermocyclers.
- Cas collateral cleavage (Cas12/Cas13):
- guided cleavage triggers reporter signal.
- Lateral-flow output (Paper Strip):
- visual result in <30 min, no instrument.