Roche launches two new cyclospora tests as US outbreak widens

• The PCR tests can detect cyclospora and other gastrointestinal parasites, with options to screen for one, three, or six parasites across different testing platforms to help labs tailor costs
• U.S. health authorities expanded their investigation after detecting cases in six additional states, bringing the total to 15 states with 6,358 cases and 278 hospitalizations
• Cases have risen steadily across 47 states in recent months, with the outbreak tied to iceberg lettuce from central Mexico making it one of the largest cyclosporiasis outbreaks in U.S. recent history

Summary

Key Development:

Roche (Swiss healthcare company) launched two new PCR tests on August 6 to detect cyclospora parasites as the U.S. faces one of its largest foodborne illness outbreaks in recent history. The company is collaborating with its subsidiary TIB MOLBIOL for test supply.

Product Details:

The PCR tests identify pathogens through genetic material detection and can screen for cyclospora along with other gastrointestinal parasites. The portfolio offers flexibility, allowing laboratories to choose between screening for one, three, or six parasites across different testing platforms, enabling cost customization based on institutional needs.

Outbreak Scope:

• 6,358 cases reported across 15 states (as of early August)
• At least 278 hospitalizations recorded
• Cases rising steadily with reports from 47 states nationwide
• U.S. health authorities recently expanded investigations into six additional states
• Outbreak linked to iceberg lettuce from central Mexico

Market Context:

This represents one of the largest cyclosporiasis outbreaks in recent U.S. history, with case numbers reaching record levels in 2023. The CDC and FDA note that surveillance data lags state reporting by several weeks, suggesting actual case numbers may be higher.

Implications:

The launch positions Roche to capitalize on increased diagnostic demand driven by the outbreak. The flexible testing platform addresses varying laboratory budgets and needs, potentially expanding market penetration. The ongoing outbreak underscores growing concerns about foodborne illness prevention and the critical role of rapid diagnostic testing in public health response.