Anywhere Dx

About the offering

Anywhere Dx is a Boston, MA-based early-stage company developing an at-home molecular diagnostics platform, starting with a strep throat test. The company was co-founded by CEO Nathalya Mamane (20+ years in business creation, former RT MicroDx founder) and Dr. Michael Mina (MD, PhD), a globally recognized diagnostics leader with ties to Harvard, MIT Sloan, and the Broad Institute who led the US government's test-to-treat program during the COVID-19 pandemic. The R&D team also includes Dr. Nikhil Gopalkrishnan, a molecular diagnostics specialist with 15+ years of experience bringing FDA-authorized OTC products to market. The core product is a palm-sized, instrument-free, single-use molecular strep test designed for over-the-counter home use. It uses lyophilized isothermal amplification with a visual lateral-flow-style readout — the same gold-standard molecular approach used in clinical labs — rather than the less accurate antigen/lateral-flow tests currently available for home use. Prototype performance has shown approximately 98% sensitivity and 97% specificity. The company targets a consumer retail price under $25 with a cost of goods under $5. The intended user workflow is: OTC purchase → mouth swab → run test → scan result in app → virtual telehealth visit → e-prescription sent to pharmacy, all in under one hour. The company is post-prototype and is working toward FDA regulatory submission (De Novo or 510(k) pathway, targeted for Q2 2026). Current fundraise proceeds are intended for: finalizing device design for manufacturability, locking in contract manufacturing partners, completing pre-clinical work and setting up pivotal validation studies, regulatory engagement and pre-submission package preparation, and building out the test-to-treat workflow integrations. Anywhere Dx has received non-dilutive funding from both the NSF and NIH, which the company cites as external technical validation. The platform is designed to expand beyond strep into UTIs, STIs, GBS, Flu/RSV, HPV, and other high-frequency infections using the same core technology. The company frames its go-to-market around two revenue engines: (1) a branded direct-to-consumer and B2B2C channel through telehealth and retail pharmacies, and (2) white-label partnerships with established diagnostics or consumer health brands. The company cites a total addressable market of $64B+ in diagnostics, with 60M+ strep tests performed annually in the US alone. It positions itself as an acquisition target for large diagnostics companies (Abbott, Roche, BD, etc.) that typically acquire proven platforms rather than build from scratch. The current Wefunder crowdfunding round is structured as a SAFE with a $5M valuation cap and a 20% discount to the next priced round. The company has raised approximately $243,537 from 64 investors on Wefunder to date and has indicated plans for a subsequent $5M seed round after this community raise closes.

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