Nuclein

Austin-based Nuclein, LLC is a medical device company established in 2017 by seasoned biotechnology entrepreneurs Alan Blake and Dr. Richard Crockett. The initial idea stemmed from Blake's concerns about the Zika virus, highlighting a need for accessible at-home diagnostics even before the COVID-19 pandemic. The founders previously collaborated on Yorktown Technologies, the company behind GloFish®, the first widely commercialized biotech animal, which they successfully exited in 2017. This prior experience in navigating FDA regulations and bringing a novel biotech product to a mass market provided a strong foundation for Nuclein.

Nuclein's core offering is the DASH® Rapid PCR System, a point-of-care (POC) platform designed to deliver laboratory-quality PCR results in approximately 15 minutes. This system addresses a critical gap in the diagnostics market, which has traditionally forced a choice between the speed of less accurate antigen tests and the high accuracy of slower, more expensive lab-based PCR tests. The DASH system includes a compact instrument, a barcode scanner, and single-use test cartridges, requiring less than a minute of hands-on time and no special technical expertise to operate. In January 2025, the company received FDA 510(k) clearance and a CLIA waiver for its DASH® SARS-CoV-2 & Flu A/B Test, which uses a single anterior nasal swab. A significant milestone occurred in 2023 when Nuclein merged with Minute Molecular Diagnostics, a Northwestern University spin-out that originally developed the DASH technology.

The company's business model centers on the sale of the DASH® instrument and the recurring revenue from disposable, test-specific cartridges. Nuclein targets a wide array of healthcare settings, including urgent care centers, physician offices, student health clinics, pharmacies, and emergency rooms, enabling a "test and treat" approach within a single patient visit. The system's design incorporates features like room temperature storage for cartridges, Wi-Fi and cloud connectivity for workflow integration, and multiplexing capabilities to test for multiple pathogens simultaneously. The company has raised approximately $50 million, led by private equity firm Trinity Investors, to fund commercialization and expansion. Nuclein is actively developing a broader test menu, with plans to include diagnostics for other respiratory infections and sexually transmitted infections (STIs).

Keywords: point-of-care diagnostics, rapid PCR testing, molecular diagnostics, medical devices, infectious disease testing, in-vitro diagnostics, CLIA-waived, FDA cleared, DASH PCR system, respiratory testing, flu testing, COVID-19 testing, diagnostic equipment, sample-to-answer, multiplex PCR, healthcare technology, Alan Blake, Minute Molecular Diagnostics, Trinity Investors, point-of-care technology