Prostate Cancer at-Home Testing

An Accurate and Rapid at-home testing kit utilizing

Biomarkers at an Affordable Price

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Executive Summary

The Future of Disease Diagnosis

Problem

Solution

Outcomes

Current urine based testing for prostate cancer lack specificity and sensitivity while being overly expensive for the average person

• Current testing has a false-positive rate of 15% and a false-negative rate of up to 35%
• Common PSA testing for men with a PSA level of 4-10 ml has a specificity of 20-45%
• Unspecific tests lead to inaccurate results and unnecessary biopsies, leading to greater expenses for multiple stakeholders
• These biopsies cost upwards to $2500, a cost most families cannot afford

Convenient at home urine based collection kits, to test prostate cancer. These tests will be sent to a lab for results. This test will have high specificity, sensitivity, and accuracy.

• Testing for 3 specific biomarkers, (PCA3, GSTP1, AMACR) rather than just one which is proven to provide more accurate results all combined into one simple test
• Lab will use various purification and extraction methods, along with PCR to analyze/quantify biomarkers and provide results back to the customer

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A test with higher accuracy than any of today's urine-based prostate cancer tests and prevent misdiagnosis.

• This test will prevent false negatives and false positives saving the patients a headache and giving them accurate results for a serious disease such as prostate cancer
• Saving patients money from the unnecessary biopsy by an estimated $2500
• Give a competitive advantage over competitors in the medical testing industry capturing more of the $10 billion dollar market value that prostate cancer testing holds

What does a patient's current

testing/treatment process look like

Understanding the current status quo

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Diagnosis

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Treatment and Follow-up

The prostate-specific antigen (PSA) blood test is most common amongst testing, but is not specific to prostate cancer. The specificity of the PSA test in men with a PSA level of 4-10nl/mL is approx 20-45% and a number of men with elevated PSA levels have experienced unnecessary prostate biopsy. This can ultimately lead to unnecessary anxiety.

Learn more about the problem he

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The last step is one patients remember forever. Current treatment processes can be emotionally taxing for men, and cause much financial burden. According to the Canadian Cancer Society, a prostate cancer biopsy costs approximately $880.

Testing

The status quo: 1 in 5 men are unaware they have prostate cancer. The question is why? Numerous factors contribute to this result, including; a lack of trust in our healthcare system, inconvenience and discomfort, fear of treatment and fear of diagnosis. To increase the number of diagnosis, these factors MUST be ameliorated.

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Information

The At Home Collection Kit

Our Idea

Idea:�Our idea is an at home collection kit that patients can order online to be delivered to their home. Once the tests are delivered the patient will follow the instructions for the urinary collection tests. One their collection kit is completed the patient will have the kit collected by our trucks. These trucks will keep the urine fresh until delivered to the lab. The lab will test the urines DNA for the biomarkers, notify the patient, and follow up with the patient

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What sets us apart:�Our test have high specificity, sensitivity, and accuracy higher than the current status quo for urine based tests. Along with that we include prostate manipulation which increases the levels of biomarkers in the urine.

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Learn more about prostate manipulation here

Our Vision

View vision board here

How The Test Will Work

Collection kits

After the patient follows the instructions on the collection kit, and the urine is in the kit. A truck will go and pick the package up, until picked up patients will be asked to refrigerate the tests. Once collected by the truck the urine will reach our lab where we will test for our biomarkers DNA

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1. The at-home collection kit will be testing for 3 specific biomarkers (PCA3, GSTP1, AMACR) in the urine sample
2. The cells in the urine will firstly be lysed. Lysed refers to the cells being “broken open” to release DNA
3. After this the DNA will be purified from the lysed cells using various methods such as organic extraction, silica spin columns, or magnetic beads.
4. Once the DNA is extracted and purified it can be amplified using a technique called polymerase chain reaction (PCR), which makes multiple copies of the DNA and allows it to be analyzed.

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Learn more about DNA testing here

PCA3 Gene

Biomarker #01

The PCA3 is a RNA gene that is over-expressed in prostate cancer cells. It is specific to prostate cancer cells rather than all prostate cells, and, if present in urine it’s an indication of prostate cancer

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The PCA3 gene has been shown to have a 82.4 percent sensitivity, and 77.8 percent specificity. PCA3 has a 98 percent accuracy.

PCA3 is a non-encoding gene which means that it does not code(create) a protein. This gene produces a spliced, long non-coding RNA. Non-coding genes does things like regulate gene expression, DNA-nucleosome interactions, DNA order, and more.

Accuracy

Gene information

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Learn more about the PCA3 Gene biomarker here

DNA Testing

PCA3

PCA3 does not encode for any protein but it does still have DNA. Heres and example of what the PCA3’s genes DNA would be similar to:

CCC GAA GAG UCA UUA UUG GCU GCC UCU GCA GCA GAG GCU UCU UCG GAG CCC GAG UCA CGC CCU

GGG CTT CTC AGT AAT AAC CGA CGG AGA CGT CGT CTC CGA AGA AGC CTC GGG CTC AGT GCG GGA

GAA GAG CCC CGC CCU GAA CCA CCG UCU UCU UCU GCU UCU UCA GAG GAA UUC UUA UUG UCU GCU

CTT CTC GGG GCG GGA CTT GGT GGC AGA AAG AGA CGA AGA ACT CTC CTT AAG AAT AAC AGA CGA

UCU CGC GAA UUC UCU GCU UCU UCA GAG UCA UUC UCU GCA GAA GAG CCC CCA CCG UCU CCG UCU

AGA GCG CTT AAG AGA CGA AGA AGT CTC AGT AAG AGA CGT CTT CTC GGG GGT GCG AGA GGC AGA

GAG GCC GAA CCA CCG UCU UUC CCC GAG CGC GAA CCA CCG UCU CCU GAA CCA GAA CCA UCU CCG

CTC CGG CTT GGT GGC AGA AAG GGG CTC GCG CTT GGT GGC AGA GGA CTT GGT CTT GGT AGA GGC

The DNA part is underlined

GSTP1 Gene

Biomarker #02

GSTP1 is a protein-coding gene, it encodes for glutathione S-transferase P1. Is a member of large enzyme families, that plays an important role in the detoxification and antioxidant system. The protein/gene is present in prostate cancer.

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This shows a 73 percent accuracy and a 98 percent specificity. GSTP1 has a 90 percent accuracy.

This protein/gene is involved in a variety of functions. This includes metabolism, detoxification, elimination of potentially genotoxic foreign complexes. It also metabolizes a variety of carcinogenic compounds, and protects cells against DNA damage.

Accuracy

Gene Information

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Learn more about the GSTP1 Gene biomarker here

DNA Testing

GSTP1

The GSTP1 genes encodes for glutathione S-transferase P1. The main

amino acids in this include arginine, asparagine, cysteine, phenylalanine,

tyrosine, serine, and valine

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When testing for this protein an example of DNA thats similar to this gene’s DNA is:

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GCU AAU UGC UCC GUC GUC GUA CGA CGG CGG AAU UUC UAC UUC UGC UCC GUG AAU CGG AAC UUU

CGA TTA ACG AGG CAG CAG CAT GCT GCC GCC TTA AAG ATG AAG ACG AGG CAC TTA GCC TTG AAA

CGA UAC UAC UCG CGA AGC GUG CGG UGC UUU UAU AGU GUA AAC GUG CGG UAC AAU UGC UCC CGG

GCT ATG ATG AGC GCT TCG CAC GCC ACG AAA ATA TCA CAT TTG CAC GCC ATG TTA ACG AGG GCC

UGC UUC UGC UCC GUG CGG AAC UUU UAC UCG CGA AGC GUG GUA CGA CGG UUC GUA CGA AAC AAC

ACG AAG ACG AGG CAC GCC TTG AAA ATG AGC GCT TCG CAC CAT GCT GCC AAG CAT GCT TTG TTG

UAC UCG AGC UGC AAC GUG AAC CGC AAU UAC GUA GUU CGG AAC AAC UUU GUG AAC UAC CGG AGU

ATG AGC TCG ACG TTG CAC TTG GCG TTA ATG CAT CAA GCC TTG TTG AAA CAC TTG ATG GCC TCA

The DNA part is underlined

AMACR Gene

Biomarker #03

The AMACR gene makes the alpha-methyl acyl-CoA racemase. This protein is present in urine, and is involved in peroxisomal beta-oxidation of dietary branched-chained fatty acids. This is been consistently overexpressed in prostate cancer

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This hows a 98 percent sensitivity and a 54 percent specificity. AMACR has a 89.3 percent accuracy.

AMACR is found in the energy producing part of the cell called the mitochondria. And is found in cell structures called peroxisomes. The gene encode the racemase (AMACR)

Accuracy

Gene Information

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Learn more about the AMACR Gene biomarker here

DNA Testing

AMACR

The GSTP1 genes encodes for glutathione S-transferase P1. The main

amino acids in this include arginine, asparagine, cysteine, phenylalanine,

tyrosine, serine, and valine

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When testing for this protein an example of DNA thats similar to this gene’s DNA is:

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AGA UUA GAU GAC CCU CCG GGC AUU AUA CUG GAU AAC GGG AUC CGC CGA CGG AAC GAC CCG CCC

TCT AAT CTA CTG GGA GGC CCG TAA TAT GAC CTA TTG CCC TAG GCG GCT GCC TTG CTG GGC GGG

UUC AUA CUG CGG CCA AUC GGA CGU AAC AGG CUU GGG CCC GGU CGG CCG UUU UUC CGG AAU AUA

AAG TAT GAC GCC GGT TAG CCT GCA TTG TCC GAA CCC GGG CCA GCC GGC AAA AAG GCC TTA TAT

GGG AAC CCG AUA UUA CGG UUU GAC CUG AUC GGG UUC UUA CCG CGA AUC AAC GAU CUU GGA AUA

CCC TTG CCG TAT AAT GCC AAA CTG GAC TAG CCC AAG AAT GGC GCT TAG TTG CTA GAA CCT TAT

CCA AUC GGA GGG AUC CGC GGG CCC GGU AAC GAC CCG CCC CUG CGG CCA CCG GGC AUU UUU AGG

GGT TAG GGT CCC TAG GCG CCC GGG CCA TTG CTG GGC GGG GAC GCC GGT GGC CCG TAA AAA TCC

The DNA part is underlined

Total Accuracy Of Our Test

The sensitivity of the biomarker(gene) or the test

The specificity of the biomarker(gene) or the test

The accuracy of the biomarker(gene) or the test

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Implementation Plan

The Journey from Now to the Future

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Prototype Building

Prototypes can be formulated with the exact components that are included inside including the mechanisms to make sure they work exactly like they are intended to

Testing Process

Actual method for testing and identifying for biomarkers in sample must be created with the help of external machinery and test the accuracy of these machines to make them ready for actual patient tests

Clinical Trials

Actual testing with patient samples are conducted to test accuracy of the test itself as well as make improvement. Split into a 3 phase testing process with different sample sizes for each trial

Product in Market

After results are proven to work 100% of the time, product is put out for consumer use on the Switch Health website where they can order a testing kit, send in a urine sample to the lab, and get their results

More on the Implementation Plan Here

Financial Planning

Costs

Currently we are aiming for a retail price of $180. The development of the tests will cost an estimated 4.25 million.

More about finances here

Benefits and Outcomes

More Diagnosis

More diagnoses of prostate cancer can lead to earlier detection of the disease, which can increase the chances of successful treatment and improved outcomes.

Improved Public Health

By identifying and treating prostate cancer earlier, the overall health of the population can improve, potentially reducing healthcare costs and improving quality of life.

Advantage/Awareness

Prostate Cancer is most commonly diagnosed by healthcare practitioners. Alongside Switch Health, patients can utilise one of the first reliable at-home testing kits, which increases not only global awareness, but decreases healthcare costs concurrently.

More on mitigating risks here

The Patient Journey

Mapping Out

A patient could either be at risk for prostate cancer or want to be cautious. So they will order the test off of Switch Health website

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Learn more about patient care here

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Click here for patient journey

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The test will go out for shipping. And the patient will be able to track the location throughout the Switch Health website

Once the patient receives the package, they will follow the instructions for the collection kit and store it in their fridge until a truck comes to pick it up

The test will be taken to a lab where the urine will be tested. Patients can check the status of the test through the Switch Health Website

Once the patient gets theri results, they will follow up with us. And treatment plans/paitent care will start.

Seeking Validation

Vice President @ Klick Labs

“Prostate cancer is a disease that many men often have trouble testing for due to its private nature. Your idea can not only improve the costs of testing for both patients and hospitals, but it can also help so many men overcome their rooted anxiety in the issue of testing for a prostate related diseases.”

Yan Fossat

Jaya Sra

Aarav Patel

Dear Switch Health,

Thank you for giving us this opportunity to make a real change in the world of health care and learn more about medicine!

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Krishna Mehta

Mihika Khetarpal

Jaya Sra

Aliza Ahmad