When Standard Testing Doesn’t Fit: Developing a Bespoke Efficacy Strategy

Efficacy Testing Strategy

How Test Labs helped KISANALITIKA develop a scientifically defensible, standards-informed efficacy testing strategy for TIXAR®

For most manufacturers, proving that a product works is only part of the challenge. 

The bigger question is whether the product’s efficacy claims can be evaluated through scientifically robust testing capable of supporting regulatory assessment. 

When KISANALITIKA Ltd. prepared to introduce TIXAR®, its poultry litter disinfectant and conditioner, into new international markets, the company encountered a problem that couldn’t be solved with a standard testing approach. 

TIXAR® had demonstrated promising performance in practical use, but there was no straightforward way to evaluate its efficacy claims using an existing EN/ISO methodology. 

Several laboratories had been unable to identify an appropriate testing approach, leaving KISANALITIKA without the independent efficacy evidence required to support its planned international regulatory submissions. 

That’s where Test Labs came in. 

About KISANALITIKA

KISANALITIKA Ltd. is an analytical laboratory and manufacturer specialising in hygiene and biosecurity solutions for agriculture. 

Alongside its laboratory testing services, the company develops and manufactures TIXAR®, a dry litter disinfectant designed to improve hygiene and disease prevention in poultry production. 

Its Plant Manager oversees production while also supporting procurement, business development, sales and investment planning.

The Challenge: Establishing a Scientifically Defensible Method of Evaluating Performance

International expansion depended on one critical requirement: generating efficacy data that could support regulatory submissions. 

Although TIXAR® had a strong track record in practical use, KISANALITIKA needed objective laboratory evidence to substantiate its efficacy claims 

The challenge was translating that real-world performance into objective, scientifically robust evidence generated through an appropriate EN/ISO testing methodology. 

TIXAR®’s unique characteristics meant that existing standards did not easily fit the product or its intended use. Applying a conventional test without addressing those differences risked producing data that would not properly represent the product’s performance. 

KISANALITIKA had already approached several laboratories, but none could offer a testing methodology that adequately addressed the problem. 

Without an appropriate testing strategy, the company faced: 

• Potential delays to regulatory approvals 
• Barriers to international market expansion 
• Uncertainty around future licensing 
• Increased commercial and regulatory risk 

“Despite extensive efforts, no available provider was able to offer a clear or suitable testing methodology tailored to our product’s specific characteristics”– said Tamás Pál.

Why Test Labs?

KISANALITIKA needed an independent testing partner capable of investigating a problem for which there was no obvious off-the-shelf methodology. 

That was what stood out about Test Labs. 

Rather than applying a potentially unsuitable methodology, Test Labs first examined the product’s characteristics, intended use and proposed efficacy claims to determine what the testing needed to evaluate objectively. 

“What truly distinguished your team was not only technical capability, but also your genuine commitment to finding a way forward.” – Plant Manager added. 

The Test Labs Solution: Developing a Bespoke Testing Strategy

The project began with detailed technical discussions between the two teams. 

Test Labs examined: 

• The composition and characteristics of TIXAR® 
• Its mechanism of action 
• How the product is used in poultry environments 
• The performance characteristics that needed to be demonstrated 
• The regulatory expectations in KISANALITIKA’s target markets 
• The extent to which existing EN/ISO methodologies could be applied 

From there, Test Labs developed a bespoke efficacy testing strategy informed by relevant EN/ISO standards, with any necessary adaptations supported by scientific justification. 

The team needed to interpret the relevant standards, understand where conventional approaches fell short and determine how the testing could be structured to produce meaningful, scientifically defensible evidence for the product. 

Test Labs worked closely with KISANALITIKA during method development, while retaining responsibility for the objective design, execution and reporting of the testing. 

Regular communication between the teams was particularly important because the testing strategy was being developed around the specific characteristics of the product rather than a standard laboratory test.

The Outcome

Test Labs established a bespoke, standards-informed efficacy methodology capable of evaluating TIXAR® objectively and generating data for consideration in future regulatory submissions. 

TIXAR® is now backed by efficacy data generated through an approach aligned with recognised EN/ISO expectations, giving KISANALITIKA a stronger evidence base as it prepares for international market expansion. 

The project has provided: 

• A bespoke efficacy testing strategy suited to TIXAR® 
• Greater confidence in future regulatory submissions 
• Objective evidence relating to the product’s efficacy claims 
• A clearer foundation for international market expansion 
• Better insight into how the product should be evaluated in future development and validation work 

The commercial impact will come as international licences are secured, but the testing project has already given KISANALITIKA greater confidence in its regulatory pathway. 

More Than a Testing Project

The company needed an independent technical partner capable of developing a scientifically defensible approach to a problem without an obvious standard methodology. 

Test Labs did not force TIXAR® into a predetermined test method. The team assessed the product’s intended use, characteristics and proposed claims before developing an appropriate method for evaluating its efficacy objectively. 

Before definitive testing began, the study conditions, controls and efficacy criteria were defined and documented. The methodology was designed to determine objectively whether TIXAR® met those criteria – not to predetermine a successful outcome. 

“The most valuable aspect of this collaboration was your team’s willingness to engage with a challenge that initially had no clear or straightforward solution” – Tamás explained. 

“A highly competent and reliable partner who combines scientific expertise with true commitment to solving complex problems.” 

Looking Ahead

With a bespoke efficacy testing methodology now established, KISANALITIKA is preparing for the next stage of TIXAR®’s growth. 

Future plans include expanding into additional international markets, developing new products and continuing to strengthen regulatory compliance across its portfolio. 

The company expects Test Labs to remain a technical partner as new development, testing and certification challenges arise.