# CRISPR diagnostics

Cas-enzyme nucleic-acid detection — point-of-care molecular diagnostics from sample to lateral-flow readout.

Source: https://en.bioecon.ru/technology/crispr-diagnostics/
Updated: 2026-08-18



## Overview and value chain

Markers: [EC: IVDR 2017/746 | OECD: Biotech & Health | Regulator: FDA (USA), EMA (EU), NMPA (China)]

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:
1. **SHERLOCK (Cas13 RNA detection):** RNA targets via collateral cleavage.
2. **DETECTR (Cas12 DNA detection):** DNA targets with reporter readout.
3. **Isothermal coupling (RPA/LAMP front-end):** amplification at constant temperature.
4. **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.

---

## US

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.

---

## CN

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.

---

## EU

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.

---

## Leading companies and research institutes

| 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 |

---

## Tech stack and innovations

The stack couples amplification, guided cleavage and a simple readout.

1. **Isothermal amplification (RPA/LAMP):**
   - constant-temperature amplification without thermocyclers.
2. **Cas collateral cleavage (Cas12/Cas13):**
   - guided cleavage triggers reporter signal.
3. **Lateral-flow output (Paper Strip):**
   - visual result in <30 min, no instrument.

---

## Value chains and production pipelines

### Industrial pipeline of a CRISPR IVD (ISO 13485)

```
┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Sample lysis           │ ───> │ 2. Isothermal amp         │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Reporter cleavage      │ <─── │ 3. Cas/gRNA reaction      │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Lateral-flow readout   │ ───> │ 6. Result reporting       │
└───────────────────────────┘      └───────────────────────────┘
```

#### Stage 1: Sample lysis
A 200 µL swab is lysed to release nucleic acids within 5 min.

#### Stage 2: Isothermal amplification
RPA/LAMP amplifies targets at 37–42 °C in 10 min.

#### Stage 3: Cas/gRNA reaction
Guide RNA directs Cas to the target sequence, detecting down to 10 copies per reaction.

#### Stage 4: Reporter cleavage
Collateral cleavage activates over 1000 reporter molecules per target.

#### Stage 5: Lateral-flow readout
A paper strip shows a visual positive/negative line in 5 min.

#### Stage 6: Result reporting
The result is captured to the patient record at about 0.61 USD per test.