Cubit Diagnostics Secures Funding for Integrated Diagnostic Platform

CARLSBAD, Calif. – May 07, 2026 – Cubit Diagnostics, a company developing a novel, all-in-one diagnostic system, today announced it has closed a new round of SAFE (Simple Agreement for Future Equity) financing. The capital injection is set to accelerate the development of its integrated benchtop analyzer, specifically funding the final design stages of a key infectious disease test and the expansion of its broader testing menu.

The announcement signals a critical step forward for the Carlsbad-based company, which aims to merge two distinct types of medical testing—molecular diagnostics and immunoassays—into a single, user-friendly platform. This latest funding provides the runway to achieve crucial milestones, including locking in the design for its molecular assay for Chlamydia, Gonorrhea, and Trichomoniasis (CT/NG/TV).

"We have the right team, a clear path forward, and the capital to achieve the next key milestones," said Kunal Sur, CEO of Cubit Diagnostics, in a statement. "Getting to design freeze on CT/NG/TV this year and into a clinical study in 2027 is what this phase is about."

A New Frontier in Point-of-Care Diagnostics

Cubit Diagnostics is tackling a long-standing challenge in clinical settings: the need for multiple, disparate machines to run different types of diagnostic tests. Hospitals and clinics often rely on separate instruments for molecular tests, which detect genetic material like DNA or RNA, and immunoassays, which detect proteins or antibodies. This fragmented workflow can lead to delays, increased costs, and require significant lab space and technician training.

The company’s core innovation is a compact benchtop analyzer designed to perform both types of tests from a single patient sample. This integrated approach promises to dramatically simplify clinical workflows, enabling healthcare providers to get a more comprehensive diagnostic picture in a fraction of the time. According to the company, the platform is being engineered to deliver molecular results in approximately 15-20 minutes and immunoassay results in under 10 minutes.

This capability for rapid, multi-modal testing at the point of care could empower clinicians to make immediate treatment decisions during a single patient visit, a significant improvement over centralized lab testing that can take hours or days to return results. The system leverages proprietary microfluidics and sample purification technologies to achieve what it describes as lab-quality performance in a decentralized format.

"Putting molecular and immunoassay into one platform is novel and compelling, and we're incredibly excited about the progress we continue to make," Sur added.

Tackling STIs at the Point of Care

The immediate focus for the new funding is the advancement of the company's CT/NG/TV molecular assay. Sexually transmitted infections (STIs) like Chlamydia, Gonorrhea, and Trichomoniasis represent a significant and growing public health concern. Rapid and accurate diagnosis is essential for timely treatment, which helps improve patient outcomes and prevent further transmission.

By developing a fast, reliable test that can be run directly in a doctor’s office, urgent care clinic, or community health center, Cubit aims to address a critical gap in STI management. The ability to test and treat in the same visit eliminates the risk of patients being lost to follow-up while awaiting lab results, a common problem that can hinder public health efforts. The company is targeting a design freeze for the assay in the fourth quarter of 2026, which would pave the way for a pivotal clinical study in the first half of 2027.

Beyond STIs, the platform’s dual capabilities are designed to support a wide array of future tests. The company has indicated progress on its immunoassay menu and plans to expand into other clinical areas such as respiratory infections, cardiology, and women’s health, making the analyzer a versatile tool for various healthcare settings.

Building Momentum with Capital and Expertise

The successful SAFE financing round provides the financial fuel for this next development phase, but it follows another strategic move to bolster the company's leadership. Cubit recently strengthened its board of directors with the appointment of two seasoned diagnostics industry veterans, Robert Bujarski and Mark Paiz.

Both Bujarski and Paiz bring extensive experience from their time in leadership at Quidel Corporation (now QuidelOrtho). Bujarski, formerly the COO of QuidelOrtho, was instrumental in scaling the company's revenue from $60 million to over $3 billion and oversaw hundreds of global regulatory product clearances. Paiz, a former COO of Quidel, has deep expertise in operations, commercialization, and clinical trial logistics, having also founded and successfully exited a clinical packaging company.

This infusion of executive talent, with specific experience in scaling diagnostic companies, navigating complex regulatory pathways, and bringing products to market, provides a powerful complement to the new funding. It signals a deliberate strategy to prepare the company for the rigorous process of clinical validation, regulatory approval, and commercial launch.

Navigating the Path to Market

Cubit’s timeline of a 2027 clinical study places it firmly on the well-trodden but challenging path to regulatory approval. Any new in vitro diagnostic (IVD) device in the United States must secure clearance or approval from the Food and Drug Administration (FDA) before it can be marketed for clinical use.

For a novel device like Cubit's, this typically involves a 510(k) submission, which demonstrates that the new device is substantially equivalent to an existing, legally marketed device, or a more rigorous Premarket Approval (PMA) application for higher-risk devices. Given the point-of-care nature of the platform, a key goal will likely be to obtain a CLIA Waiver from the FDA. A CLIA-waived designation certifies that a test is simple enough to be performed accurately by non-laboratory personnel, which is essential for broad adoption in decentralized settings.

The planned clinical study will be critical for generating the performance and safety data required to support a future FDA submission. Successfully navigating this regulatory process is a capital-intensive and time-consuming endeavor, underscoring the importance of the company’s recent financing and leadership additions as it moves from the development stage toward commercial reality.