{"data":{"type":"company_profile","id":194590,"entity_id":"wefunder:company:194590","attributes":{"canonical_url":"https://wefunder.com/anywhere.dx","generated_at":"2026-06-13T03:10:52Z","updated_at":"2026-06-13T03:05:36Z","entity_ids":{"company":"wefunder:company:194590","slug":"wefunder:company_slug:anywhere.dx"},"profile_visibility":{"owner_published":true,"public_search_results":true,"site_search_listed":true,"privacy_mode":"promote","invite_only":false},"provenance":{"source":"wefunder_public_company_profile","as_of":"2026-06-13T03:10:52Z","claims":{"total_amount_raised":{"source":"FrontCompanySummary#amount_raised","last_verified_at":"2026-06-13T03:05:36Z","as_of":"2026-06-13T03:10:52Z","confidence":"high"},"total_investors":{"source":"FrontCompanySummary#number_of_investors","last_verified_at":"2026-06-13T03:05:36Z","as_of":"2026-06-13T03:10:52Z","confidence":"high"},"active_raise_states":{"source":"Fundraise.visible(nil, nil)","last_verified_at":"2026-06-10T14:01:25Z","as_of":"2026-06-13T03:10:52Z","confidence":"high"},"latest_fundraise_state":{"source":"Fundraise.visible(nil, nil).order(funding_started_at)","last_verified_at":"2026-06-10T14:01:25Z","as_of":"2026-06-13T03:10:52Z","confidence":"medium"}}},"company":{"id":194590,"entity_id":"wefunder:company:194590","slug":"anywhere.dx","name":"Anywhere Dx","tagline":"At-home diagnostics for time-sensitive infections: starting with strep.","story":"The way we diagnose everyday infections is about to change.It already happened with pregnancy tests.It already happened with COVID.Now it’s happening to strep—and everything after it.And the companies that make this shift happen don’t just improve healthcare…They become category leaders.Our ThesisAnywhereDX is focused on high-volume, time-sensitive infections where delays matter and access is broken.Strep testing is the perfect starting point as it meets this criteria and hasn’t changed in 20 years.Yet we know the market is ready.Consumers have shown (from COVID) the willingness to test at home.Physicians have shown buy in to trust at home results.Telehealth is becoming the standard.The reality is: if we don't bring this device to market, someone else will.The Hoops You Jump Through NowRisks of WaitingAnd if you wait too long?Strep isn’t just uncomfortable—it can lead to serious complications, including rheumatic fever and permanent heart damage.Yet often times parents are choosing between a $250 urgent care visit and making rent.This is not a small problem.It’s a high-frequency, time-sensitive, emotionally charged decision happening millions of times per year.The Shift This system is already breaking.And consumers have already moved on.COVID normalized at-home testingTelehealth normalized remote carePatients expect answers NOWThe infrastructure is ready.The behavior has already changed.👉 Diagnostics just hasn’t caught up yet.The SolutionAnywhere Dx is building the missing layer:At-home, lab-quality diagnostics for time-sensitive infections. Starting with strep.Why We winImmediate answers with accurate results at the cost of a copayMost testing forces a trade off. Ours doesn’t.We use molecular diagnostics (not antigen tests)→ lab-level accuracy at homeWe price under $25→ accessible, repeatable useWe connect directly to care→ not just a test, a full workflow👉 This isn’t a product. It’s a behavior shift.Why this works nowThis only works now because three things changed:1. Consumer behavior → people are comfortable testing at home2. Technology → molecular testing without instruments is now possible3. Care delivery → telehealth enables instant treatmentAt the same time:• Strep testing hasn’t changed in 20+ years• Clinics are overloaded• Costs keep rising👉 This gap shouldn’t exist anymore—and won’t for longWHY YOU INVESTWhy Early Investors WinYou’re not investing in a strep test.You’re investing in a platform shift in diagnostics.Here’s what makes this compelling:1. You’re early$5M valuation capPre-commercialBefore regulatory + scale milestones👉 This is the lowest entry pointA lower valuation cap means at the next priced round, you get a higher percentage of shares for the same price as someone else investing at that round. 2. This is not a one-product companyStrep is the starting point.Same platform expands into:UTIsSTIsGBSother high-frequency infections👉 Each new test increases company value3. This becomes repeat behaviorThis isn’t a one-time device.Families test multiple times per yearHigh-frequency useBuilt-in demand👉 That’s how real revenue compounds4. This is an acquisition-driven categoryLarge diagnostics companies:don’t build from scratchthey acquire proven platforms👉 If Anywhere Dx works, it becomes a targetMarket → Opportunity → Exit This is a massive category:60M+ strep tests annuallybillions spent each yearrepeat, high-frequency usageAnd that’s just the starting point.The broader diagnostics market exceeds $60B+👉 If Anywhere Dx captures even a small share:this becomes a large-scale revenue businesswhich is exactly what drives acquisitions and exitsEarly ProofWorking prototype with strong early performanceBacked by NSF + NIHClear path to clinical validation and regulatory progressBuilt by a diagnostic team that shipsWhy NowEarly investors receive:20% discount on future equity$5M valuation capThis round happens before major value inflection points:validationregulatory progressproduct scaling👉 Waiting means investing later at a higher valuationWhat this Round AchievesFinalize device design for manufacturabilityLock in contract manufacturing partnersComplete pre-clinical work and set up pivotal validation studiesRegulatory engagement and pre-submission package preparationBuild the “test-to-treat” workflow integrations (scan → telehealth → pharmacy)How Your Investment WorksYou’re investing early—before commercialization and scaleYour SAFE converts into equity in a future roundEarly investors receive better terms than later investorsAs Anywhere Dx grows into a multi-test diagnostics platform, the value of that early ownership can grow with itThe Bottom LineDiagnostics hasn’t kept up with how people live.That’s changing.And the companies that fix itwill define the next generation of care.If you believe:• answers should be immediate• care should be accessible• and this shift is inevitable👉 This is your chance to invest early.Skip the chaos at the clinic. Test for strep at home.Everyone understands a pregnancy test: simple, private, fast. Once that shift happened, there was no going back.Same thing with Covid tests. Before Covid, at-home testing was rare. Now, it’s second nature.The shift has already happened. Now it’s coming to everyday infectious disease.We’re starting with strep so families can get a lab-quality answer at home and connect to treatment without losing the day.Anywhere Dx is building a palm-sized, instrument-free molecular strep test for home use:OTC purchase → run the test → scan → virtual visit → eRxDesigned to take you from “Is it strep?” to care in under an hour, priced under $25, with COGs at $5.Led by a team with deep experience building, scaling, and commercializing at-home diagnostics: This is your chance to support a proven team tackling a high-frequency, deeply broken category with a scalable approach.If you’re a parent, you know the moment: your kid wakes up miserable, throat on fire, and suddenly your entire day is hijacked. You’re forced into the same broken set of options - call right at 8 am and hope, sit in urgent care purgatory, pull your kid out of school for an invasive swab, and then wait again for an answer you needed hours earlier.And for clinicians, it’s just as frustrating. Telemedicine has moved faster than diagnostics, leaving providers to make decisions without data. Without reliable home testing, doctors are forced to guess, driving unnecessary visits, delayed treatment, and avoidable antibiotic use. The result is a system that burns time, money, and trust just to answer a simple question.Healthcare still makes people jump through hoops for answers that should be immediate. For everyday infections like Strep, UTIs, and STIs, patients are forced into clinic visits, long waits, and high costs—just to get the information they need quickly to make decisions.And it’s not a small problem—this is a multi-billion dollar diagnostic category that touches millions of families every year, with no true at-home standard.We’re fixing that.Our company is building a consumer-first molecular diagnostics platform that delivers lab-quality results in real time. Our first product is an at-home Strep test, developed to give families fast, accurate answers without a doctor office visit or lab infrastructure.Unlike most home tests on the market today, our technology is based on molecular diagnostics, the same gold-standard approach used in clinical laboratories. This enables significantly higher sensitivity and specificity than traditional lateral-flow or antigen tests, while remaining simple enough for everyday home use.We are post-prototype and advancing toward commercialization with strong external validation. Our work has been supported by non-dilutive funding from both the NSF and NIH, recognizing not only the technical merit of our approach but also its potential to expand access to care and reduce system-wide healthcare costs.Strep is just the beginning.Our platform is intentionally designed to scale across multiple high-need at-home, clinic, and hospital diagnostic use cases, including GBS, UTIs and STIs, using the same core technology and user experience. This creates a repeatable, extensible product pipeline rather than a single-test business.We’re pursuing a consumer-based first model, meeting parents and adults where they already are - anywhere - while building toward a future where high-quality diagnostics are accessible without friction, delays, or unnecessary appointments.The diagnostics market is expanding rapidly, but most existing solutions trade accuracy for convenience. We believe consumers shouldn’t have to choose. The next generation of testing will be both clinically credible and consumer-friendly, and that’s the company we’re building.We’re raising this round to advance regulatory progress, expand our test menu, and bring a truly scalable diagnostic platform to market. We invite investors to join us early as we bring molecular diagnostics out of the lab and into everyday life.Strep Testing Made SimpleEverybody can relate to a pregnancy test: simple, private, fast. We’re building the equivalent model for strep throat, so you can get a lab-quality answer at home with a workflow that fits real life.We’re giving families and clinicians the missing layer that makes modern care actually work.Four Steps. One Straight Line to Treatment.Pick up the test (OTC—pharmacy/retail).Swab inside the mouth to collect saliva (simple and kid-friendly).Run the test and read a visual result (positive/negative).Immediate access to care for treatment: upload in-app for confirmation, prescription sent to your pharmacy or home.This is what “test-to-treat” is supposed to feel like:A straight line from symptom → answer → treatment.The Three Advantages That Compound1) Molecular accuracy—without instrumentsWe use lyophilized isothermal amplification with a visual, lateral-flow style readout—so there’s no lab in a single-use, fully disposable solution.2) Price that can actually scaleUltra-low COGS (target \u0026lt; $5) enables a consumer price \u0026lt; $25 with treatment included— a product families will actually buy again and again.3) A noninvasive workflow people will actually useWe’re delivering the full experience: simple, family-friendly sample collection and analysis, plus a connected path to treatment.OTC purchase → run the test → scan → eRx.That end-to-end flow is what drives repeat behavior, builds defensible distribution, and turns a single test into a platform.Momentum You Can MeasureHere’s what’s already in place today:A working prototype with credible early performance anchors (bench LoD and prototype performance framing).Non-dilutive validation: NSF/NIH support helped create momentum and fund progress toward a working prototype.Near-final device design + manufacturing planning baked into the staged roadmap (contract manufacturer identification + pivotal studies sequencing).A Clear Path to MarketWe’re executing a milestone-gated regulatory strategy that builds trust and revenue step by step. This phased approach is informed by the team’s firsthand experience taking diagnostics through validation, regulatory review, and commercialization pressure-tested in real markets, creating billions in revenue.We’re Building a Category - Not a Single TestWe’re not betting the company on one channel.Engine 1: Branded Anywhere DxSell directly under Anywhere Dx online and in stores, plus B2B2C into telehealth/pharmacies for a complete test-to-treat workflow.Engine 2: White-label partnershipsPartner with established brands and distribution to accelerate penetration and revenue—common in point-of-care diagnostics.Start with Strep. Expand to a Platform.Strep A is the beachhead: high volume, time-sensitive, painful workflow. But the real story is the platform expansion across GBS, UTIs, STIs, HPV..., unlocking $64B in diagnostics opportunity.Built by People Who DeliverWe built Anywhere Dx with a simple standard: this has to be real science, built into a real product, by people who know how to do both.Nathalya Mamane (MBA), CEO \u0026amp; Co-Founder: Founder and operator with 20+ years building and scaling companies; former RT MicroDx founder and award-winning entrepreneur focused on making high-quality diagnostics affordable, accessible, and commercially viable at scaleDr. Michael Mina (MD, PhD), CSO \u0026amp; Co-Founder: Globally recognised diagnostics founder and operator with deep experience translating science into commercial products. Letmultiple device and health companies, generating billions in revenue, led the US government test-to-treat program during the pandemic; MIT Sloan senior lecturer and former professor, Harvard/BWH/Broad Institute, and advisor across clinical, regulatory, and go-to-market strategy.Dr. Nikhil Gopalkrishnan (PhD), Director of Assay Development \u0026amp; R\u0026amp;D: Molecular diagnostics leader with 15+ years developing high-performance assays from concept to FDA-authorized OTC products, including respiratory and infectious disease tests spanning COVID, Flu, RSV, and StrepStephen Kelley, Device Development: Manufacturing and automation engineer with 15+ years designing scalable diagnostic hardware; deep expertise in design-for-manufacture, robotics, and lab automation supporting rapid prototyping through production-ready systemsWhy Invest NowWe launched Anywhere Dx out of our own pocket, and we’ve earned early trust from agencies like NSF and NIH. Now we’re opening this up so you can join us and help turn a working prototype into a product that can scale into the real world and into YOUR hands.Use-of-fundsFinalize device design for manufacturabilityLock in contract manufacturing partnersComplete pre-clinical work and set up pivotal validation studiesRegulatory engagement and pre-submission package preparationBuild the “test-to-treat” workflow integrations (scan → telehealth → pharmacy)Investors in this round receive a SAFE convertible note at a 20% discountBuild the Future of At-Home DiagnosticsIf you believe diagnostics should finally catch up to the digital age, this is your chance to help build it.Invest (choose your level)Share with a parent, clinician, or operator who “gets” why this mattersFollow our milestones (we’ll post progress updates)","location":"Boston, MA","website":"https://www.anywhere.health","total_amount_raised":80449,"total_investors":36,"is_funded":false,"is_active":true,"quality_score":1,"related_urls":["https://wefunder.com/anywhere.dx","https://www.anywhere.health"]},"media":{"share_image_url":"https://uploads.wefunder.com/uploads/company/header_media_photo/194590/xxl_avatar.jpg","header_media_url":"https://uploads.wefunder.com/uploads/company/header_media_photo/194590/standard_avatar.jpg","cover_photo_url":"https://uploads.wefunder.com/uploads/company/header_media_photo/194590/standard_avatar.jpg","pitch_deck_url":"https://wefunder.com/rails/active_storage/blobs/redirect/eyJfcmFpbHMiOnsiZGF0YSI6MTI0NDA1MSwicHVyIjoiYmxvYl9pZCJ9fQ==--922c6d60ab64cc725c2ebf1cce1a573b8db7c7a5/avatar.jpg","pitch_deck_filename":"avatar.jpg"},"links":{"company_url":"https://www.anywhere.health","linkedin_url":"https://linkedin.com/company/anywhere-dx/","twitter_url":"https://x.com/AnywhereDx","facebook_url":"https://facebook.com/profile.php?id=61585757194545","instagram_url":"https://instagram.com/anywhere.dx/","tiktok_url":"https://tiktok.com/@anywhere.dx?lang=en"},"highlights":[],"quick_facts":[{"index":1,"claim_id":"claim-fact-1","value":"Lab-quality accuracy at home ~98% sensitivity / 97% specificity (prototype)"},{"index":2,"claim_id":"claim-fact-2","value":"From symptom → treatment in under an hour Test, telehealth, and prescription in one flow"},{"index":3,"claim_id":"claim-fact-3","value":"Built for mass adoption Target price under $25, no clinic required"},{"index":4,"claim_id":"claim-fact-4","value":"Backed by NSF + NIH Non-dilutive funding validating the technology"},{"index":5,"claim_id":"claim-fact-5","value":"Not a single test—a platform Expansion roadmap includes UTIs, STIs, Flu/RSV, and more"},{"index":6,"claim_id":"claim-fact-6","value":"Massive market opportunity Targeting a $64B diagnostics category"},{"index":7,"claim_id":"claim-fact-7","value":"World-class team Led by Dr. Michael Mina (Harvard/Broad, test-to-treat leader)"},{"index":8,"claim_id":"claim-fact-8","value":"Early entry before scale inflection Invest ahead of commercialization and Seed round"}],"team":[{"id":6565259,"entity_id":"wefunder:company_role:6565259","user_entity_id":"wefunder:user:5008851","role":"founder","name":"Nathalya Mamane","title":"Co-founder and CEO","bio":"20+ years in successful business creation. Visionary entrepreneur and strategist with a track record of building successful companies.","avatar_url":"https://uploads.wefunder.com/2021/user_default_icon_circle.png?1775232264","profile_url":"https://wefunder.com/nathalya.mamane.1","linkedin_url":"https://linkedin.com/nathalya-mamane","related_urls":["https://wefunder.com/nathalya.mamane.1"]},{"id":6578339,"entity_id":"wefunder:company_role:6578339","role":"founder","name":"Dr. Michael Mina","title":"Co-founder and CSO","bio":"Immunologist, Epidemiologist, globally recognized, 20+ years in infectious disease technology and public health leadership.","avatar_url":"https://uploads.wefunder.com/2021/user_default_icon_circle.png?1775232264","linkedin_url":"https://linkedin.com/in/michael-mina-md-phd-711918113/","twitter_url":"https://x.com/x.com/michaelmina_lab","related_urls":[]},{"id":6578340,"entity_id":"wefunder:company_role:6578340","user_entity_id":"wefunder:user:5022229","role":"employee","name":"Nikhil Gopalkrishnan","title":"Director of Assay Development \u0026 R\u0026D:","bio":"Molecular diagnostics leader with 15+ years developing high-performance assays from concept to FDA-authorized OTC products, including COVID, Flu, RSV, and Strep tests","avatar_url":"https://wefunder.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsiZGF0YSI6MTI0NjU1MywicHVyIjoiYmxvYl9pZCJ9fQ==--049a2782be5254ebcd240e8a960f5aaddaf7a231/eyJfcmFpbHMiOnsiZGF0YSI6eyJmb3JtYXQiOiJqcGciLCJyZXNpemVfdG9fZmlsbCI6WzE1MCwxNTBdfSwicHVyIjoidmFyaWF0aW9uIn19--bf3c219dc08c5143daeaf3bef02977955ac3d453/filename?1775232264","profile_url":"https://wefunder.com/nikhil.gopalkrishnan","linkedin_url":"https://linkedin.com/linkedin.com/in/nikhil-gopalkrishnan-863111176/","related_urls":["https://wefunder.com/nikhil.gopalkrishnan"]},{"id":6578341,"entity_id":"wefunder:company_role:6578341","role":"employee","name":"Stephen Kelley","title":"Device Development","bio":"Manufacturing and automation engineer with 15+ years designing scalable diagnostic hardware; deep expertise in design-for-manufacture, robotics, and lab automation supporting rapid prototyping through production-ready systems","avatar_url":"https://uploads.wefunder.com/2021/user_default_icon_circle.png?1770088409","linkedin_url":"https://linkedin.com/in/stephen-kelley-24850323/","related_urls":[]}],"featured_investors":[{"id":13563,"entity_id":"wefunder:company_investor_profile:13563","investor_profile_id":4596435,"investor_profile_entity_id":"wefunder:investor_profile:4596435","subject_entity_id":"wefunder:user:5103033","name":"Samanda Morales","role_title":"","bio":"Over 24+ years in finance, including roles at State Street, BNY, WellFin360 founder and as a mother myself, AnywhereDX is personal.","avatar_url":"https://wefunder.com/rails/active_storage/blobs/redirect/eyJfcmFpbHMiOnsiZGF0YSI6MTg3MjM0OSwicHVyIjoiYmxvYl9pZCJ9fQ==--41dac7f292a3a740b6a63937c59ef9aedda178c0/filename","profile_url":"https://wefunder.com/samanda.morales","endorsement_quote":"With a career in finance and experience as an angel investor, I've evaluated many opportunities and AnywhereDX stands out. As a mother myself, I know the uncertainty of watching your child struggle through a sore throat at 2am, not knowing if it's strep and wondering whether to wait it out or make a trip to urgent care. Co-founder Nathalya felt exactly that. A mother of four who lived this problem firsthand and decided to build the solution. With 20+ years scaling businesses, she has the conviction and the experience to make it real. Alongside her is co-founder Dr. Michael Mina, former Harvard professor and the leading global voice on rapid diagnostics, who advised the White House and Congress during COVID-19. What they've built is remarkable: a lab-grade strep test you can take at home. No swab, no scanner, no lab. A soft pad in the cheek, a result in 25 minutes, read like a pregnancy test. They have expertise and genuine human purpose. I personally invested because I believe in this team and this mission.","endorsement_name":"","investment_total":20000,"investment_info":"Invested $20,000 this round","is_lead_investor":true,"related_urls":["https://wefunder.com/samanda.morales"]},{"id":13383,"entity_id":"wefunder:company_investor_profile:13383","investor_profile_id":4578614,"investor_profile_entity_id":"wefunder:investor_profile:4578614","subject_entity_id":"wefunder:notable_investor:17358","name":"Diana Guthe","role_title":"","bio":"Diana Berrent Güthe is the Founder of SurvivorCorps, the world’s largest Covid Advocacy movement and, more recently, the Founder and CEO of Pandemic Prep Consulting LLC. She is a native New Yorker and trusted disrupter in the world of health and science.","avatar_url":"https://wefunder.com/rails/active_storage/blobs/redirect/eyJfcmFpbHMiOnsiZGF0YSI6MTcxODY4MCwicHVyIjoiYmxvYl9pZCJ9fQ==--1e22921f50379d87e54a1a3d3e61624972c0248d/avatar.jpg","profile_url":"https://wefunder.com/diana.guthe","endorsement_quote":"It’s time to bring precision medicine to the medicine cabinet. At-home testing means fewer missed wages, fewer delays, and faster treatment while catching simple infections early before they turn into life threatening diseases. That’s progress EVERY parent can believe in.","endorsement_name":"","investment_total":10000,"investment_info":"Invested $10,000 this round","is_lead_investor":false,"related_urls":["https://wefunder.com/diana.guthe"]},{"id":13387,"entity_id":"wefunder:company_investor_profile:13387","investor_profile_id":4580151,"investor_profile_entity_id":"wefunder:investor_profile:4580151","subject_entity_id":"wefunder:notable_investor:17376","name":"Karlin Bacher","role_title":"","bio":"Karlin Bacher serves as the Senior Director of Population Health for a Federally Qualified Community Health Center in Buffalo, New York where he works to improve clinical outcomes among underserved patient populations.","avatar_url":"https://wefunder.com/rails/active_storage/blobs/redirect/eyJfcmFpbHMiOnsiZGF0YSI6MTcyNDA1NSwicHVyIjoiYmxvYl9pZCJ9fQ==--44c9b3d979ddc31a7179db0d2b771911b83c992a/avatar.jpg","profile_url":"https://wefunder.com/karlin.bacher.1","endorsement_quote":"Why is it 2026 and our health system is still functioning like it's 1976? The technology is here, and now we can offer it in an accessible and affordable manner. Since becoming a father, who sometimes has sick kids, I have actively looked for a solution like this. This is truly game changing! It just makes sense.","endorsement_name":"","investment_total":1000,"investment_info":"Invested $1,000 this round","is_lead_investor":false,"related_urls":["https://wefunder.com/karlin.bacher.1"]}],"investor_memos":[],"tab_counts":{"posts":0,"ask_questions":2,"featured_investors":3,"faq_entries":2},"active_fundraises":[{"id":159487,"entity_id":"wefunder:fundraise:159487","state":"successful","offering_type":"4(a)(6)","funding_type":"note","structure":"ttw","security_type":"","currency":"USD","testing_the_waters":true,"min_purchase":100,"max_purchase":9,"funding_target":1235000.0,"minimum_target":"50000.0","maximum_target":"1235000.0"},{"id":159486,"entity_id":"wefunder:fundraise:159486","state":"open","offering_type":"4(a)(6)","funding_type":"note","structure":"safe","security_type":"equity","currency":"USD","testing_the_waters":false,"min_purchase":100,"max_purchase":9,"funding_target":50000.0,"minimum_target":"50000.0","maximum_target":"1235000.0","funding_started_at":"2026-06-08T23:43:37Z","funding_closed_at":"2026-10-01T03:59:59Z"}],"latest_fundraise":{"id":159487,"entity_id":"wefunder:fundraise:159487","state":"successful","offering_type":"4(a)(6)","structure":"ttw","testing_the_waters":true,"can_invest_now":false,"funding_started_at":null,"funding_closed_at":null,"terms":{"eb":"$4.5M","nb":"$5M","txt":"valuation cap"}},"recent_posts":[],"q_and_a":[{"id":335148,"entity_id":"wefunder:comment:335148","question":"Hello, I have some questions. I apologize if these were already answered in the pitch. What specific FDA pathway do you expect for the at-home Strep A test, and what milestones remain before submission and clearance? The pitch deck says q2 2026 for this “de novo vs 510k” How many patient samples have been tested so far, and were the reported sensitivity and specificity generated from prospective clinical samples or retrospective/laboratory testing? How difficult is it to adapt the platform from Strep A to additional assays such as UTI, STI, respiratory pathogens, or HPV? What prevents Abbott, Roche, BD, or another major diagnostics company from developing a similar test? I see that after this raise, a 5mm raise is planed, at what valuation? If everything goes according to plan, what is the next major value-inflection event that would likely attract acquisition interest? Would you consider selling after FDA approval if you were given an offer, or would you continue to build it out?","author_name":"Ali Ahmad","votes":0,"created_at":"2026-06-07T22:04:42Z","canonical_url":"https://wefunder.com/anywhere.dx#question-335148","answers":[{"id":335261,"entity_id":"wefunder:comment:335261","answer":"Thank you, Ali, for these questions. This is exactly the kind of diligence we welcome, and I will answer each one directly.On the FDA pathway, we are targeting 510(k) clearance for our at-home Strep A test. The Q2 2026 date in the deck has been updated, and our current near-term milestone is a Q-sub meeting with the FDA, which is the formal pre-submission step that aligns us with the agency on our pathway and data requirements before we proceed to submission.For clinical samples, we are progressing through a rigorous validation process that adheres to established regulatory standards. Our current data comes from bench work, and our $300K raise includes a small clinical study to validate and build on those findings. Full prospective clinical validation is a key milestone of our $5M seed round.Regarding platform adaptability, our platform's architecture is intentionally indication-agnostic. Adapting to a new target requires developing and validating a new assay with the right target primer design and adapting our current sample prep process to a new sample type. The core process and form factor do not change, which is what makes this a platform rather than a single-product company. Group B Strep is our planned second indication, with respiratory pathogens, STIs, and UTIs all within scope. Our defensibility comes from a patent-pending, fully integrated single-use molecular system, a patent submission covering our proprietary clean-and-concentrate sample preparation process, and the complexity of achieving instrument-free amplification at the sensitivity levels we are targeting. As for the large diagnostics players, companies like Abbott, Roche, and BD are not in the business of building solutions like ours. They are in the business of acquiring them and commercializing them at scale. We have already had early conversations with a few of them who have expressed genuine interest and are waiting for more data from us before engaging in more serious discussions.For the next $5M seed round, we are targeting a $25M post-money valuation and are happy to discuss further with serious investors off-platform.On value inflection and acquisition, the most significant inflection point will come upon completion of our FDA clinical trials and submission. That is the moment this becomes an asset that strategic acquirers take seriously. We have already had conversations with large companies that are closely monitoring our progress and have expressed interest in deeper engagement once we reach that milestone. To answer your question directly: we would consider a strategic acquisition at the right valuation and the right moment. We are building this to create the most value possible, and we will follow the path that best serves our mission of putting diagnostics in the hands of families at home.","author_name":"Nathalya Mamane","votes":0,"created_at":"2026-06-09T14:30:18Z"}]},{"id":335023,"entity_id":"wefunder:comment:335023","question":"Other than of course raising funds, what's your next operational steps - (a) what are you working on that doesn't require you to raise beyond $1M and (b) what's key item you'll work on upon raising $1M?","author_name":"James Mantz","votes":0,"created_at":"2026-06-05T14:59:27Z","canonical_url":"https://wefunder.com/anywhere.dx#question-335023","answers":[{"id":335035,"entity_id":"wefunder:comment:335035","answer":"James, thank you for asking. I want to make sure I answer this with precision because milestone-based thinking is exactly how we run this company.Our current Wefunder raise targets $300K, serving as a bridge to a $ 5M-priced seed round we are actively building toward. So let me answer in those terms, because that is the honest picture:We are in the final stages of analytical validation for our Strep A assay, while advancing our manufacturing partnership and building our FDA pre-submission. These workstreams are all in motion. This raise does not start our engine but rather accelerates it, and, critically, funds the completion of our end-to-end working prototype.The 300K capital raise extends our runway, funds key lab milestones that strengthen our seed-round narrative, and allows us to deepen the manufacturing and regulatory groundwork that makes the $5M raise a much cleaner conversation for institutional investors.The next seed raise will fund the development of a finished consumer solution, a full clinical validation study for the FDA data package, the acceleration of a second indication (to prove the platform technology), and an FDA submission. That is the raise that takes us from where we are today to commercial-launch-ready in two years.","author_name":"Nathalya Mamane","votes":0,"created_at":"2026-06-05T18:13:13Z"}]}],"faq":[{"question":"Other than of course raising funds, what's your next operational steps - (a) what are you working on that doesn't require you to raise beyond $1M and (b) what's key item you'll work on upon raising $1M?","answer":"James, thank you for asking. I want to make sure I answer this with precision because milestone-based thinking is exactly how we run this company.Our current Wefunder raise targets $300K, serving as a bridge to a $ 5M-priced seed round we are actively building toward. So let me answer in those terms, because that is the honest picture:We are in the final stages of analytical validation for our Strep A assay, while advancing our manufacturing partnership and building our FDA pre-submission. Th..."},{"question":"Hello, I have some questions. I apologize if these were already answered in the pitch. What specific FDA pathway do you expect for the at-home Strep A test, and what milestones remain before submission and clearance? The pitch deck says q2 2026 for this “de novo vs 510k” How m...","answer":"Thank you, Ali, for these questions. This is exactly the kind of diligence we welcome, and I will answer each one directly.On the FDA pathway, we are targeting 510(k) clearance for our at-home Strep A test. The Q2 2026 date in the deck has been updated, and our current near-term milestone is a Q-sub meeting with the FDA, which is the formal pre-submission step that aligns us with the agency on our pathway and data requirements before we proceed to submission.For clinical samples, we are progr..."}]}}}