Medical Disclaimer

Last Updated: October 2025

Important Notice

THE INFORMATION PROVIDED ON THIS WEBSITE IS FOR EDUCATIONAL AND INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED AS MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT.

Please read this Medical Disclaimer carefully before using this website or considering the Colosafe® screening test.

1. Not Medical Advice

1.1 General Information Only

All content on this website, including text, graphics, images, and information about Colosafe® screening tests, is for general informational purposes only. It is not intended to be:

• Medical advice
• A substitute for professional medical judgment
• A recommendation for treatment
• A diagnosis of any health condition
• A prescription or therapeutic recommendation

1.2 Consult Healthcare Professionals

You should always:

• Consult with a qualified healthcare professional before making any medical decisions
• Seek the advice of your doctor or other qualified health provider with any questions about a medical condition
• Never disregard professional medical advice or delay seeking it because of something you have read on this website

1.3 Emergency Situations

IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR OR EMERGENCY SERVICES IMMEDIATELY.

If you are experiencing symptoms such as:

• Rectal bleeding
• Blood in stool
• Persistent abdominal pain
• Unexplained weight loss
• Changes in bowel habits
• Anemia

Seek immediate medical attention. Do not wait for screening test results.

2. Screening Test vs. Diagnostic Test

2.1 Colosafe® Is a Screening Test

Colosafe® is a screening test, not a diagnostic test. Understanding this difference is critical:

Screening Test:

• Primarily designed for people WITHOUT symptoms
• Can also be used in people WITH symptoms as part of evaluation
• Identifies individuals who MAY have a disease or condition
• Indicates increased risk requiring further investigation
• Not definitive proof of disease

Diagnostic Test:

• Used to confirm or rule out disease
• Typically performed after a positive screening or when symptoms present
• Provides definitive diagnosis
• Example: Colonoscopy is a diagnostic procedure

Important: If you have symptoms (bleeding, pain, weight loss, bowel changes), you should consult a healthcare professional promptly. While Colosafe® can be used in symptomatic individuals, your doctor may recommend direct colonoscopy or other diagnostic procedures instead.

2.2 What Colosafe® Does

Colosafe® detects certain DNA markers in stool samples that MAY indicate the presence of colorectal cancer or precancerous polyps.

2.3 What Colosafe® Does NOT Do

Colosafe® does not:

• Diagnose colorectal cancer
• Replace colonoscopy
• Eliminate the need for follow-up testing if positive
• Eliminate all risk of colorectal cancer if negative

3. Test Limitations and Accuracy

3.1 No Test Is 100% Accurate

Like all medical tests, Colosafe® has limitations:

False Negatives (Test Says Negative, But Disease Present):

• No screening test detects 100% of cancers or polyps
• You may have colorectal cancer or polyps even with a negative result
• Continue regular screening as recommended by your doctor

False Positives (Test Says Positive, But No Disease Present):

• A positive result does not mean you definitely have cancer
• A positive result requires follow-up colonoscopy for confirmation
• Many positive results are due to polyps or other non-cancerous conditions

3.2 Factors Affecting Accuracy

Test performance may be affected by:

• Sample collection quality
• Timing of sample collection
• Certain medications or dietary factors
• Bleeding from non-cancerous sources (hemorrhoids, menstruation)
• Laboratory processing errors

3.3 Clinical Studies

While clinical studies demonstrate Colosafe®'s effectiveness, published studies represent:

• Controlled clinical settings
• Specific patient populations
• Average performance across many individuals
• Your individual results may differ

4. Interpretation of Results

4.1 Positive Result

A positive Colosafe® result means:

• DNA markers associated with colorectal cancer or polyps were detected
• You need a colonoscopy for further evaluation
• It does NOT confirm you have cancer
• Many positive results are due to precancerous polyps or other conditions

What to do:

• Contact your healthcare provider immediately
• Schedule a colonoscopy as recommended
• Do not panic - early detection allows for effective treatment

4.2 Negative Result

A negative Colosafe® result means:

• No DNA markers were detected at the time of testing
• It provides reassurance but NOT a 100% guarantee
• You could still have colorectal cancer or polyps that were not detected
• Continue regular screening as recommended by your doctor

What to do:

• Follow your healthcare provider's recommendations for repeat screening
• Seek immediate medical attention if you develop symptoms
• Maintain regular screening schedule

4.3 Invalid or Inconclusive Result

If your test cannot be processed or provides unclear results:

• This does not mean you have or do not have cancer
• You may need to repeat the test
• Contact your healthcare provider for guidance

5. Not a Replacement for Medical Care

5.1 Not a Substitute for Colonoscopy

Colosafe® does not replace:

• Colonoscopy for high-risk individuals
• Colonoscopy as a follow-up to positive screening
• Colonoscopy when symptoms are present
• Diagnostic procedures recommended by your doctor

5.2 Follow Medical Guidance

Your healthcare provider may recommend:

• Direct colonoscopy instead of stool-based screening
• More frequent screening based on your risk factors
• Different screening methods based on your medical history

Always follow your healthcare provider's recommendations.

5.3 Regular Screening

• Screening is an ongoing process, not a one-time event
• Negative results require repeat testing at appropriate intervals
• Screening guidelines may change over time

6. Who Should and Should Not Use Colosafe®

6.1 Appropriate Users

Colosafe® may be appropriate for:

• Adults at average risk for colorectal cancer (asymptomatic screening)
• Individuals following screening guidelines
• People with symptoms, as determined by their healthcare provider

Important: If you have symptoms, consult your healthcare provider FIRST. They will determine whether Colosafe® is appropriate or whether you need direct colonoscopy or other diagnostic procedures.

6.2 Consult Your Doctor First If You Have:

• Family history of colorectal cancer or polyps
• Personal history of colorectal cancer, polyps, or inflammatory bowel disease
• Genetic syndromes associated with colorectal cancer (e.g., Lynch syndrome, FAP)
• Current symptoms (bleeding, abdominal pain, weight loss, bowel changes) - your doctor may recommend direct colonoscopy instead
• Are taking certain medications (e.g., blood thinners)

Your doctor will determine whether Colosafe® is appropriate or whether you need different screening or diagnostic approaches based on your individual risk factors and symptoms.

6.3 When Direct Colonoscopy May Be Preferred

Your healthcare provider may recommend direct colonoscopy rather than stool-based testing for:

• Individuals with severe or concerning symptoms
• Those with significant family history of colorectal cancer
• People with prior colorectal polyps or cancer
• High-risk genetic conditions
• Other clinical situations as determined by your doctor

However, your healthcare provider will make the final determination about which test is most appropriate for your individual circumstances.

7. Responsibility for Medical Decisions

7.1 Your Responsibility

You are responsible for:

• All medical decisions regarding your health
• Consulting with qualified healthcare professionals
• Following up on test results appropriately
• Seeking prompt medical attention when needed

7.2 No Provider-Patient Relationship

Using this website or ordering a Colosafe® test does not create a healthcare provider-patient relationship with:

• Screenlink Healthcare Ltd
• Eurofins Biomnis Ireland
• Creative Biosciences (Guangzhou) Co., Ltd.

7.3 Individual Circumstances

Medical decisions should be made:

• Based on your complete medical history
• In consultation with your healthcare provider
• Considering your individual risk factors and circumstances
• Following current medical guidelines and best practices

8. Limitations of Website Information

8.1 General Information

Information on this website:

• Represents general information about colorectal cancer screening
• May not apply to your specific situation
• Is not tailored to your individual health needs
• Should not be used to self-diagnose or self-treat

8.2 Medical Knowledge Evolves

• Medical science and screening guidelines change over time
• Information on this website may become outdated
• Always consult current medical guidelines and your healthcare provider

8.3 Not Comprehensive

This website does not provide:

• Comprehensive information about all aspects of colorectal cancer
• Detailed information about all screening or treatment options
• Personalized medical recommendations

9. No Guarantees or Warranties

9.1 No Guarantee of Health Outcomes

We make no guarantees regarding:

• The effectiveness of Colosafe® screening for any individual
• Prevention, detection, or cure of colorectal cancer
• Any health outcomes from using or not using the test

9.2 Performance May Vary

Individual test performance may vary based on:

• Individual health status
• Timing and method of sample collection
• Stage and type of disease (if present)
• Other individual factors

10. Regulatory Status

10.1 Product Approval

• Colosafe® is a CE IVD (In Vitro Diagnostic) marked device
• Manufactured by: Creative Biosciences (Guangzhou) Co., Ltd.
• Distributed in Ireland by: Screenlink Healthcare Ltd

10.2 Regulatory Compliance

CE IVD marking indicates:

• The product meets European safety and performance requirements
• This is NOT equivalent to FDA approval in the United States
• Regulatory requirements and approved uses may differ by country

11. Liability Disclaimer

11.1 No Liability for Medical Outcomes

To the fullest extent permitted by law, Screenlink Healthcare Ltd, its directors, officers, employees, and partners shall not be liable for:

• Any medical outcomes, complications, or health consequences
• Delays in diagnosis or treatment
• False negative or false positive results
• Decisions made based on information on this website or test results
• Any loss, injury, or damage arising from use or non-use of Colosafe®

11.2 Use at Your Own Risk

You acknowledge and agree that:

• Use of this website and Colosafe® test is at your own risk
• You assume full responsibility for medical decisions
• We are not responsible for the outcome of your screening or healthcare decisions

12. International Users

This website and information are primarily intended for users in:

• Republic of Ireland
• United Kingdom (future)

Medical practices, regulations, and screening guidelines may differ in other countries. Consult local healthcare providers and follow guidelines applicable in your location.

13. Changes to This Disclaimer

We may update this Medical Disclaimer from time to time. Changes will be effective when posted with a new "Last Updated" date. We encourage you to review this disclaimer periodically.

14. Contact Information

For Medical Questions: Contact your healthcare provider. We cannot provide medical advice.

For Product Information: Screenlink Healthcare Ltd

• Email: info@screenlink.net
• Phone: 01 460 5248
• Address: Unit H1, Centre Point Business Park, Oak Drive, Dublin 12, Ireland

For Order-Related Questions: Contact Eurofins Biomnis Ireland: https://www.eurofins.ie/biomnis

15. Acknowledgment

By using this website and considering or using the Colosafe® screening test, you acknowledge that:

• You have read and understood this Medical Disclaimer
• You understand that information on this website is not medical advice
• You understand that Colosafe® is a screening test, not a diagnostic test
• You will consult with healthcare professionals for medical decisions
• You accept the limitations and risks associated with screening tests
• You assume responsibility for your health decisions

‍