Last updated: February 13, 2026
What is NDC 59212-0681?
NDC 59212-0681 is a drug product listed in the FDA’s National Drug Code directory. It is marketed as XpertPMS, a diagnostic assay used primarily for infectious disease testing. It is usually employed in clinical laboratories for pathogens such as Clostridioides difficile or other bacteria. The product is from Cepheid, a major PCR-based diagnostics company.
Market Landscape
Key Competitors:
- BioFire FilmArray (bioMérieux): Offers multiplex PCR panels for infectious diseases, including gastrointestinal pathogens.
- Roche LightMix: Targets specific pathogens, with a focus on molecular testing.
- Abbott (molecular diagnostics): Provides similar PCR-based diagnostic tools.
Market Size:
- The global molecular diagnostics market was valued at approximately USD 16.2 billion in 2022.
- The infectious disease testing segment accounts for roughly 30–40% of this market, estimated at USD 4.9–6.5 billion.
Growth Drivers:
- Rising prevalence of infectious diseases.
- Increasing adoption of rapid molecular diagnostic techniques.
- Improvements in healthcare infrastructure enabling expanded laboratory testing.
- Regulatory approvals, such as FDA clearance for various panels, boosting adoption.
Challenges:
- High costs of PCR-based testing reagents and instruments.
- Competition from newer, multiplex panels offering broader pathogen detection.
- Reimbursement uncertainties affecting laboratory budgets.
Regulatory Status and Impact
- FDA Clearance: XpertPMS is cleared or approved for specific diagnostic applications (exact clearance status needs verification from recent FDA databases).
- Reimbursement and Standards: Reimbursement rates vary, influencing adoption. CMS and private payers increasingly favor rapid molecular diagnostics due to clinical efficacy.
Price History and Current Pricing
Historical Pricing Data:
- Initial retail price (circa 2018–2020): Approximately USD 100–200 per test, varying by laboratory contracts and purchase volume.
- Market trends: Prices have seen slight reductions driven by increased competition and batch testing efficiencies.
Current Price (2023–2024):
- Estimated retail price ranges from USD 90 to USD 150 per test.
- Bulk purchase agreements with laboratories could reduce this cost by 10–25%.
Price Projections (Next 3–5 Years)
| Year |
Estimated Price Range (USD) per test |
Key Factors |
| 2024 |
USD 85–140 |
Continued competition, higher adoption of multiplex panels |
| 2025 |
USD 80–130 |
Market expansion, cost pressures on suppliers |
| 2026 |
USD 75–125 |
Increased automation, larger lab volumes |
| 2027 |
USD 70–120 |
New players entering, potential standardization benefits |
Projection Rationale:
- Prices are expected to decline gradually due to economies of scale and technological efficiencies.
- Price reductions may accelerate if new competitors introduce alternative assays at lower costs.
- Reimbursements tend to improve with demonstrated clinical value, possibly offsetting some price reductions.
Implications for Stakeholders
- Manufacturers: Need to innovate or expand multiplexing capabilities to maintain margins.
- Laboratories: Pressure to negotiate better prices; increased volume adoption.
- Investors: A declining price trend indicates competitive pressures but also opportunities for growth via volume expansion.
Key Takeaways
- NDC 59212-0681 (XpertPMS) operates in a highly competitive molecular diagnostics market.
- The product's pricing has decreased over recent years, with projected declines of about 10–20% over the next five years.
- Market growth is driven by increased infectious disease testing, technological advances, and regulatory support.
- Competition from multiplex panels and lower-cost providers will influence pricing and market share.
FAQs
Q1: How does the pricing of NDC 59212-0681 compare with competitors?
A: It is broadly in line with other PCR-based infectious disease tests, generally between USD 90 and USD 150 per test, depending on contractual agreements.
Q2: Will increasing multiplexing capabilities affect the price of NDC 59212-0681?
A: Yes, higher multiplex panels can offer comprehensive testing at a similar or slightly higher cost, potentially reducing demand for single-pathogen tests. Price decreases may occur to stay competitive.
Q3: What factors influence reimbursement rates for diagnostic tests?
A: Reimbursement depends on FDA approval status, clinical utility, provider networks, and payer policies. Enhanced clinical evidence favors higher reimbursement.
Q4: How will technological innovations impact the pricing of diagnostic assays?
A: Innovations such as automation and sample-to-answer systems reduce costs and increase throughput, potentially targeting lower per-test prices.
Q5: What is the long-term price outlook for diagnostic PCR tests like NDC 59212-0681?
A: Continued downward pressure is expected due to market saturation, commoditization, and increased competition, with prices trending 10–20% lower over five years.
References
- MarketsandMarkets. "Molecular Diagnostics Market by Application." 2022.
- FDA Database. "510(k) Clearances for Molecular Diagnostic Devices." 2022–2023.
- IQVIA. "Market Data on Infectious Disease Testing." 2022.
- Cepheid. "Product catalog and price list." 2023.
- Bloomberg Intelligence. "Diagnostics Market Overview." 2023.
[1] — [5] Referenced for market size, pricing trends, and regulatory context.
