Rapid non-invasive home diagnostic for Celiac - initial screening of tTG IgA antibody

week 10 | 15 interviews | 101 total41 hypotheses to test - 31 invalidated

hypotheses80 survey responses

Jeroen Bekaert, PhDGSB Sloan Fellow

Director at J&JSaaS Entrepreneur

Lennon Lee, PhDPhD Candidate

in EEStanford Ignite

Anne Merritt, MDGSB Sloan Fellow

Clinical Instructor, E. Medicine

Michal Tal, PhDPost-Doc Fellow in

Immunology at Weissman Lab

Lucy LuMentor

Board Member at Life Science Angels

Smartphone enabled microscopy for diagnosing health status (CBC) and bacterial/viral infections at the PoC

What we do

Started using microscopy to bring diagnostics to the point of care

Ended using high sensitivity ELISA to bring diagnostics and tracking to the consumer

Tagline: Online diagnostics platform for distinguishing viral and bacterial infections

Tagline: Rapid non-invasive diagnostic screening for Celiac Disease

cellscan.me

PoC diagnosticsHome based

FDA approved diagnostics

Clinical lab testing

Vision recognition based lab diagnostics

In vitro lab diagnostics

Competitive landscape

Smartphone enabled microscopy for analysing bloodsmears at PoC

cellscan.me

FDA approved saliva/urine OTC

diagnosticsSensitive mobile

Technologies for PoC

Clinical lab testing(blood samples)

Celiac Therapies

Celiac invasive PoC tests(not FDA

approved)

Competitive landscape

Celiac Center

Cellscan.me:Rapid non-invasive home diagnostic for Celiac

Week 1:Add team

member with clinical expertise

START

Week 2:From 4 to

2 ideas

Week 3 & 4:From 2 to 1

ideas

Pivoted to lens free microscopy

Ups and down

Week 5:Population with unmet

need

Week 6:Submit

IRB

FDA approval process. What?

Week 9:Reached out to

Pharma and Food partners

& new perspective on FDA

Week 7 & 8:Struggled to find a cost-

effective solution& numbers don’t add up

What we did

I

Insurance Companies -while they couldpotentially be customers,they will likely be a strongpartner that will aid in thesupport and promotion ofthe diagnostic tool

Primary care providers -once again, potentialcustomers, but alsostrong proponents of thetechnology and tool

Stanford Medicine -potentially a big supporterthat can aid in thedevelopment and testingof the diagnostic

Revenue generated by the image recognition service(In app) revenue generated from sale of the home based diagnosticsRevenue generated by value added service based on the collected data

Cost for developing and maintaining the software platformR&D cost for developing new signatures (e.g. for infectious diseases)Diagnostic device - raw materials & labor (low cost)Marketing expense - advertisting

If consumers are using the tool to diagnose infections within a loved one, there will need to be a relationship based on trust, which develops out of transparency, reliability and support

Rapid results - Consumers and physicians will be given a quick answer to determine next steps.

Lower Costs - With accessibility placed in the consumer's and doctor's hands, there will be less spent on lab tests and unnecessary doctor visits

Ease of Use - The application will provide a seamless end-to-end process to perform cell tests and diagnose a pre-defined set of infectious diseases

Telemedicine applications of primary care providers

Digital Direct-to-Consumer - low-effort, potentially high cost

Physician Offices - Specific, easy to market value, low-cost

Patients - Any individual w/ an infection wanting information regarding his/her health.

Doctors - While the tool is powerful for patients, it can also provide doctors looking to make accurate, rapid diagnoses.

Insurance Companies - If the value prop delivers lower healthcare costs, insurance companies would likely become a customer segment to aid in distribution.

Strong partnerships with telemedecine, primary care providers and insurance companies

Network of adopting physicians that support the application.

Developing an FDA approved software platform & manufacturing a smartphone based device.Ongoing research to ensure that results are providing dependable, accurate readings.

Canva

s Hyp

othes

es D

ay 1

Initial value propositiono Smartphone enabled

deviceo FDA approved Rapid

resultso Lower costso Ease of use

Customer segmentso Patientso Doctorso Insurance Companies

W 1-4: Validate our value proposition

Hematological diseases Malaria + global health map1 2

Celiac disease3 Cervical cancer 4

Everything under the

sun!

get out of the building

W 1-4: Validate our value proposition● Interviewed experts● Eliminated 3 due to:

○ Barriers to large data collection

○ Challenges of implementation in developing countries

○ Lack of clinical utility● Learning

○ Ideation is good○ Scientists (we) are cautious○ Interviews with experts can

save time○ Too many value propositions

can be distracting and time-consuming

Hematological diseases Malaria + global health map1 2

Celiac disease3 Cervical cancer 4

Evidence based elimination

I

Celiac disease: Rapid POC ELISA-test for screening of ttg IgA antibody

Malaria: Low-cost, optical, rapid test for remote areas with Malaria

Cervical cancer: Provide POC testing of pap smear using mobile microscope.

Blood smear + CBC: Improve current lab technology & bring to POC

Infectious disease: POC diagnostic for a viral, bacterial, or allergic response

Pathologists & hemathologists - Provide feedback on immune response patterns & insights

Health Data Sources – Help in accessing and integrating ontological resources in all aspects of biomedical investigation and clinical practice.

Gastroenterologists - Feedback on Celiac disease response and screening methods.

Infectious disease doctors -Provide feedback on immune response patterns & insights

• Subscription based revenue model• Cost for developing and maintaining software platform• Diagnostic device - COGS• Marketing expense – advertisting• Optionally - R&D expense for developing new signatures

(Get) Celiac community

Patients as evangelists

Doctors as evangelistsProvide direct customer support through appInclude additional diagnostics features

• Direct-to-Consumer – subscription

• Direct-to-Customer – Professional organizations

• Primary care providers• Telehealth services (of

primary care providers)

Patients with Celiac disease (diagnosed)

Patients with symptoms of Celiac disease (undiagnosed)

People with gluten sensitivity

Pediatricians

Family Physicians

Gastroenterologists

Parents with children aged 0 – 12

Schools - Screening of Celiac Disease

• Human capital: Software and hardware

• Clinical data sets• Expertise/Intellectual

Property (to stain samples and set up device)

Developing a (FDA approved) software platform & mobile disgnostics. Ongoing research to ensure that results are providing dependable, accurate readings.

Celiac

Value P

ropos

ition

Initial value propositiono Rapid POC ELISA-test for

screening of tTG IgA antibody

Customer segmentso Patients (with Celiac disease)

W 5: Customer acquisitionLearning from customers

“If I could contribute to stop other people from making the mistakes I made, I would absolutely welcome it.”

Challenges of 6-12 month adjustment period after diagnosis

“Someone asked me if I could get rid of one disease, would I choose diabetes or celiac disease? I said celiac disease.”

“There was such a lapse in communication, especially in pediatrics when you’re trying to get little kids to describe what it feels like.”

“I really hope in the future there’s a better way of doing that biopsy. There’s gotta be some way to identify this…”

Pain of understanding a new disease process and making significant lifestyle changes

Difficulty in diagnosing Celiac disease in children

Invasive biopsy still required for diagnosis

W 5: Customer acquisitionInitial hypothesis

Target one customer segment well. Consider other revenue streams: gluten sensitive market, big data.

Unmet needs: 1) Underdiagnosis, 2) Lack of awareness and 3) Concern about gluten exposure.

Expand later to Gluten sensitive, Autoimmune diseases, Food allergies

Patient engagement is critical to our success

More needs finding in celiac and gluten free population may have led to key pivots.

Celiac market is relatively small

Consumer engagement is secondary to medical device development

Power of partnerships to minimize CAC and facilitate GET

Value of targeting a population with unmet needs helps to fill funnel

1 2

Importance of customer engagement in ideation phase

3

Power of partnership for CAC

Week 5: Customer acquisitionKey Learnings

TAM: 1% of US population has been diagnosed with Celiac; research shows that > 2% has Celiac; 7%-8% has gluten sensitivity

4

W 6: Challenges with technologyMixture of Key Activities

Depends on required sensitivity of test

Importance of validating the scienceo FDA approvalo Technology partners

Technology is feasible and low-cost

Seek Partners for Key Activities

Should we outsource technology?

W 6: Success with Stanford Celiac Program as a Partner

Can accelerate this process with the right partnerships

Importance of partnerships with physicianso Clinical researcho Patient engagement (app)o Champions of our product

IRB process will take several months

MINIMAL Viable Product: CLIA lab vs. OTC diagnostic

Data collection from patients as a revenue stream – Seek partners in Phama & Food

1 2

Experts have different viewpoints and biases (FDA): Hold interviews with two or more team members possible

3

Weeks 7-9: Revenue, channels, and partnersKey Learnings

MINIMAL viable product

Select techn. partner

Clinical trial & FDA approval

Set up diagn. platform & monitoring service

I

Celiac disease: Rapid antibody based detection for screening of ttg IgA antibody

Celiac disease: a non invasive rapid diagnostic for celiac for the purpose of followup and disease tracking

Infectious disease: POC diagnostic for a viral, bacterial, or allergic response

Technology companies looking to license their biosensors

Celiac drug companies

Companies focusing on personalized health nutrition

Stanford Celiac Program / Gastroenterologists Celiac FoundationHealth Data SourcesInfectious disease doctors

Direct sale of a) disposable device or b) device (one-time) with disposable cartridgeSubscription based revenue model for accompanying app

Cost for developing and maintaining software platformDiagnostic device - COGSMarketing expense – advertistingOptionally - R&D expense for developing new signatures

(Get) Celiac community

Patients as evangelists

Doctors as evangelistsProvide direct customer support through appInclude additional diagnostics features

• Direct-to-Consumer – subscription

• Direct-to-Customer – Professional organizations

• Primary care providers• Telehealth services (of

primary care providers)

Patients with Celiac disease (diagnosed)

Patients with symptoms of Celiac disease (undiagnosed)

People with gluten sensitivity

Pediatricians

Gastroenterologists

Family of Celiac patient

Military - Screening of Celiac Disease

Schools - Screening of Celiac Disease

Human capital: Software and hardware

Clinical data sets

Expertise/Intellectual Property

New pa

rtners

Seek for partners in pharma and food industry

Opt for CLIA lab instead of OTC diagnostics to reduce FDA burden

W 7-9: Revenue, channels, and partnersKey Learnings

Primary market

Tertiary market

COGSSG&AR&D

RetailerDistributorIDNs/GPOs

Secondary market

Celiac or gluten-sensitive?How do we expand our customer base? Maybe our value is data.

NestleTherapeutic companies

What we did

Started by focusing on microscopy to bring diagnostics to the point of care

Learned about the challenges of FDA approval for medical devices and diagnostics

By Week 3, narrowed from 4 cases to 1 based on interviews with customers, industry experts, and technology experts

Collaborated with Stanford Celiac Program to expand our product to include mobile app and EHR data

Learned about cost and feasibility of new technology for our specific use case.

Decided to partner with CLIA lab to deliver mail-in test and to focus on data collection as a new value proposition

Realized the difficulty of aligning innovative medical technology with unmet need with clear clinical use case. Submitted IRB.

Pace of class and input from teaching team and mentor kept us going.

1

Key Learnings

Viable business model? Extend to gluten-sensitive population, but different hypotheses (science, technology, channels, revenue, …)

2

Partners are critical to our success. Seek advise from partners early on.

3Celiac Center

Medical devices take time. 1) IRB, FDA processes and 2) Building relationships with acquisition partners

4