BME100 s2018:Group5 W0800 L1

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Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6
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OUR TEAM

Name: Priya Borah
Name: James Crichton
Name: Andrew Holder
Name: Kenzie Tommaney

LAB 1

Health Care Issue

Breast Cancer

Breast Cancer is the leading cancer for new cases and top 5 for all cancers for deaths. It is reported that in the USA, about 12.4% women will develop breast cancer and about 40 thousand women are expected to die in the year 2018. Currently in the USA, more than 3 million women have had treatment or currently getting treatment in 2018. Many women are blindsided with breast cancer as more than 3 quarters of the women with breast cancer have no history due to genetic mutations. The sooner that women find about breast cancer, the better as the stages and the mutations will multiply and the ability to cure the breast cancer will be very difficult. Stage 1 survival rate is close to 100% and stage 4 is only a quarter of that. This proves to show that the sooner that people get diagnosed and treated immediately for breast cancer, the survival rate is much better. The current way of diagnosing breast cancer is the feeling of lumps, mammography and biopsy, which all can be done by a doctor. If there is a better way in diagnosing and having the early detection in breast cancer, the lives that can be saved is substantial.


Our Device

The device that can be made to have early detection is to have a saliva swab to determine the proteins that are present when breast cancer is present. The swab and the device will provide an at-home diagnosis and plan of action if it does come positive. The swab will collect the patient’s saliva and then will place it back in the device to be collected and tested to see if the patient has breast cancer. The container of the device will take the saliva and test to see if the proteins are present. This device will decrease the amount of appointments to doctors and spend more and more money, with a chance of getting false results. To have this device be present, the amount of people that could buy it can be any women in the world that has a risk or don’t think they have a risk of breast cancer.

Customer Validation

Patients:
Women (and sometimes men) with high chances of getting breast cancer

Physicians:
Robert R. Kuske - Oncologist at Arizona Breast Cancer Specialists
Rajesh N. Kukunoor - Honor Health Deer Valley Medical Center

Purchasers:
Breast cancer centers

Providers:
Honor Health John C. Lincoln Breast Health and Research Center
Arizona Breast Cancer Specialists
University of Arizona Cancer Center
Arizona Mayo Clinic
Ironwood Cancer and Research Center
Comprehensive Breast Center of Arizona
Desert Breast Cancer
Arizona Breast Cancer Spec
St. Joseph's Hospital and Medical Center

Payers:
Susan G. Komen Foundation
Breast Cancer Research Foundation
American Breast Cancer Foundation
American Cancer Society
National Cancer Institute
Breast Cancer Alliance
Living Beyond Breast Cancer

Why Choose Our Product

These potential customers would be willing to validate our product because often times mammograms have false negatives, false positives and radiation from the testing that is harmful to patients. Our at home breast cancer testing kit will mitigate these false results by testing for the patients 15-3, tumor suppressor oncogene 53 and oncogene c-erbB-2 proteins.



Competitors

Device Advantages Disadvantages Market Comparison
Breast Exam Exam done by trained doctor, unlike our self-use device Relies on feeling for lumps which may or may not be cancerous (technological)

Requires trip to doctor’s office (validation)

Gives first warning to see if further tests are needed, but much less convenient than our device and does not find if cancer is present.
Mammogram Quickly finds abnormalities in breast

Very accurate for finding where possible cancer is

Needs further testing to look further into any abnormalities found (technological)

Uses X-rays, which under repeated exposure can cause cancer (health) Requires trip to doctor’s office (validation)

Multiple tests may be needed, but gives further testing that may come after our device

~$250

Breast Ultrasound Finds if lumps are solid or filled with fluid

Uses sound (no radiation) which poses minimal health risk

Requires trip to doctor’s office (validation)

Cannot detect if lumps are cancerous, so further testing may be required

Good compliment to other tests such as ours, especially if any lumps found are known to be cancerous.

$200- $1000

Biopsy Sample Examines tissue more closely to identify cancer

Give specific information on cancer and treatment options

Sharp tool used to extract tissue causing discomfort

Not for early detection Expensive

Further test after initial diagnosis, therefore it does not competing with our product.

$483-$3,303

MRI Uses a magnetic field and radio waves, therefore isn’t dangerous

Gives detailed internal view for full diagnosis Noninvasive

Expensive

Not practical for early diagnosis

Accurately diagnoses cancer, but is not for early diagnosis and doesn’t compete with our product

$2,000-$3,000




Existing Patents

Saliva sampling device and sample adequacy system (US5268148A)
Assignee: Saliva Diagnostic Systems Inc

File Date: 1990-12-18

This patent is for the invention of a device that collects and mixes saliva in immunoassay tests. It includes a collection container, a saliva collector and a sample container.

S2018-Group5 W0800 L1 Saliva 1.png S2018-Group5 W0800 L1 Saliva 3.png

Handheld diagnostic device with renewable biosensor (US7314453B2)
Assignee: Youti Kuo

File Date: 2001-05-14

This patent is for an at home bodily fluid diagnostic device. It can draw in the fluid sample, mix it with a liquid reagant, and analyze it using a microprocessor.

S2018-Group5 W0800 L1 Saliva 4.png

Method of diagnosing and monitoring malignant breast carcinomas (US6294349B1)
Assignee: Meridian Protein Technologies, LLC

File Date: 1999-03-01

This patent outlines the method for detecting breast cancer using proteins and antigens in saliva. Biomarkers such as cancer antigen 15-3, tumor suppressor oncogene protein 53 and oncogene c-erbB-2 are found in elevated levels in the saliva of women with breast cancer.

Saliva test for early diagnosis of cancers (US20050106642A1)
Assignee: Binie Lipps and Fredrick Lipps

File Date: 2003-11-19

This patent outlines the use of proteomic cancer markers in saliva for early diagnosis of several types of cancer. Based on these biomarkers, it can measure presence and severity of cancer using an ELISA test.

Fundability Worksheet

Criteria 0 1 2 3
Customer Validation x
Competitors x
IP Postion x

Justification
We gave customer validation a score of 1 because there would be high demand from patients for this more convenient, accurate, and safe diagnosis method. However, it is less clear how the providers, physicians, and payers would feel about the device. It would decrease female visits to health centers for breast cancer testing, but it would decrease the liability of false results and radiation exposure.

We gave competitors a score of 2 because the other diagnostic methods all have flaws and none compete with the at home convenience of our product, but the competition is well-established.

We gave IP position a score of 2 because although there are a few patents related to our product, there are none for a at home breast cancer saliva test. The other patents are the foundation for our device, not necessarily conflicting.



References

1) https://www.mayoclinic.org/diseases-conditions/breast-cancer/diagnosis-treatment/drc-20352475

2) http://www.breastcancer.org/symptoms/testing/types/ultrasound