CytoChip Launches CitoCBC™: The First CLIA-Waived POCT CBC Test, Pioneering a New Era in Point-of-Care Hematology

Recently, CytoChip announced that its independently developed point-of-care testing (POCT) complete blood count product, CitoCBC™, has officially received U.S. FDA 510(k) clearance and obtained CLIA-waived status.

AsThe world's first CLIA-waived POCT complete blood count (CBC) testing product,AlsoChina's First CLIA-Waived Diagnostic Product, the approval of CitoCBC™ has established a new paradigm for the global expansion of Chinese in vitro diagnostic devices.

The CLIA waiver approval criteria are stringent, demanding high precision and user-friendly, foolproof operation. This breakthrough by CitoCBC™ not only fills the gap in CLIA-waived complete blood count (CBC) testing for U.S. clinic settings but also marks the official dawn of a new era in point-of-care CBC testing.

In the past, the U.S. outpatient care system primarily relied on clinic-based family physicians and hospital-based emergency departments for initial consultations. Family physicians typically have long appointment wait times but offer relatively lower costs, making them suitable for managing chronic conditions; emergency departments provide rapid response but at a high cost, making them appropriate for treating acute, severe conditions. The gap in services between the slow access to family physicians and the high cost of emergency centers, which left acute but non-severe conditions underserved, has driven the rapid rise of urgent care clinics in the post-pandemic era.

U.S. urgent care clinics differentiate themselves with core advantages of “no appointment needed, transparent pricing, and immediate treatment.” Unlike primary care physicians, who typically require appointments scheduled days in advance and do not offer weekend hours, urgent care clinics provide walk-in services seven days a week. Due to this convenience, they are widely popular among Millennials and Gen Z (those born in the 1980s and 1990s).

According to statistics from the American College of Emergency Physicians (Reference 1), emergency department visits surpassed 200 million in 2022, accounting for approximately 20% of outpatient demand across clinics nationwide. For acute, non-critical conditions such as fever and infections, complete blood count (CBC) is one of the most commonly used tests to differentiate disease types, demonstrating significant demand in this setting.

However, traditional complete blood count (CBC) products require certification from the clinical laboratory department to be used in patient diagnosis and treatment, which limits their application in point-of-care testing.CitoCBC™’s CLIA-waived breakthrough enables emergency clinics to deliver rapid and accurate complete blood count (CBC) results without requiring laboratory certification or specialized laboratory personnel, effectively meeting the needs of point-of-care diagnosis and treatment.

Furthermore, the demand for waived complete blood count (CBC) testing is not limited to emergency clinics. In the U.S. healthcare system, 90% of outpatient visits are handled by various types of clinics. As one of the most basic and commonly performed laboratory tests, CBC has a wide range of clinical applications. Accessing CBC results during patient consultations helps physicians make accurate diagnostic and treatment decisions. Data shows that clinics annually outsource $50 billion worth of laboratory tests to third-party providers. Amid cost-containment trends in U.S. health insurance, physicians face increasing financial pressure. Bringing laboratory testing back in-house can help physicians develop new revenue streams.

A product’s FDA 510(k) clearance indicates that its testing accuracy is equivalent to that of large-scale laboratory equipment. Obtaining CLIA waiver enables non-laboratory personnel to operate the device while achieving accuracy comparable to that of clinical laboratories. CytoChip Inc.’sCitoCBC™ has obtained FDA 510(k) clearance and CLIA waiver, enabling it to address this service gap., providing fast and accurate solutions for scenarios such as clinics and pharmacies.

According to Shi Wendian, CEO of CytoChip Inc., the core technology of CitoCBC® is its independently developed microfluidic platform, OneChip®, which pioneersIntegrating high-end fluorescence flow cytometry detection technology into low-cost microfluidic chips to achieve a perfect combination of laboratory-grade detection performance and ease of use。

Traditional complete blood count (CBC) analyzers require regular calibration and maintenance, creating bottlenecks in primary care clinics and pharmacies due to difficult upkeep and low accuracy. OneChip’s innovative technology eliminates these barriers, enabling CytoChip Inc.’s products to deliver laboratory-grade precision while remaining user-friendly for non-professionals, thereby overcoming adoption challenges in primary care settings.

First, in terms of underlying technology, the OneChip microfluidics platform possesses several unique advantages. Regarding ease of use, the platform integrates fluorescence flow cytometry onto microfluidic chips. Its design allows reagents to be pre-embedded in the chip for long-term storage, with sample pretreatment and detection performed entirely within a closed system on the chip, eliminating the need for specialized operational skills. In terms of cost control, the OneChip platform also addresses the common cost challenges associated with microfluidic applications in IVD. By leveraging a simplified design structure and scalable mass-production processes, such as plastic injection molding and mobile phone screen protector lamination techniques, it achieves low costs that enable broad accessibility and widespread application.

Based on the OneChip platform, CitoCBC® delivers three distinct product advantages. First,The fluid path is for single-use only., requiring no post-deployment maintenance. Second,Consumables are integrated into a single-use test cartridge., meeting the needs of clinics and pharmacies for ready-to-use, single-use disposables. Third, through sensor design,Addressed the core challenges of achieving high-precision testing in non-laboratory settings: frequent user operational errors and inconsistent sample quality.

These technological innovations culminate in the product features of “ease of use and high precision,” helping CitoCBC® become the world’s first card-based complete blood count solution to simultaneously obtain U.S. FDA 510(k) clearance and CLIA waiver.

andThe timing of the product’s regulatory approval also coincided with a pivotal moment in the industry’s transformation.. In clinic settings, point-of-care complete blood count (CBC) testing can help providers deliver differentiated, high-quality medical services. The rapid proliferation of emergency clinics and chain clinics in recent years has continuously diverted patients from the traditional family physician model, and CytoChip Inc.’s products align with this transformative trend. In the future development of the pharmacy sector, CLIA-waived CBC testing can empower pharmacies to offer laboratory testing capabilities. Combined with online consultations, this enables an integrated service model for common conditions such as colds and fever, encompassing consultation, testing, and medication dispensing.

Over the past two decades, a variety of CLIA-waived products have continuously emerged, with waived options gradually becoming available for most common outpatient laboratory tests; complete blood count (CBC) remained the last gap.

In the past, when complete blood count (CBC) tests still needed to be outsourced to third-party laboratories, users adopted CLIA-waived products to address the diagnosis and management of single conditions, such as diabetes and respiratory tract infections.With CitoCBC completing the CLIA-waived testing portfolio, clinics and pharmacies are now empowered to fully replace third-party models for the first time, enabling comprehensive diagnosis of common conditions.

Regarding the product’s promotional strategy, Shi Wendian also noted that the company aims to first establish the product’s performance and quality by leveraging its development in the U.S. market; after achieving cost reductions through commercial scale-up, it will then turn back to serve China’s tiered diagnosis and treatment system.

The United States has a mature and large-scale tiered diagnosis and treatment system, with 90% of outpatient services delivered in clinics, providing substantial opportunities for point-of-care testing (POCT) of complete blood count (CBC). Furthermore, the U.S. healthcare system is predominantly covered by commercial insurance, resulting in higher reimbursement levels for CBC tests compared to China. A more established user base and greater profit margins can offset the high risks associated with the development and promotion of innovative products. Based on this, CytoChip Inc. will focus in the short term on achieving deep market penetration for its CitoCBC® product in the United States, expanding its market share, and solidifying its leading position in the field of POCT-based CBC testing.

Meanwhile,There is a strong social demand for complete blood count testing under China’s tiered diagnosis and treatment system.With 200,000 clinics and 600,000 primary healthcare stations across China, handling over 2 billion outpatient visits annually, these institutions suffer from relatively weak medical capabilities due to limited physician resources.More precise diagnostic tools are needed to enhance the level of medical care.

Due to the lack of exempted complete blood count (CBC) products in China, the convenience of medical services is significantly restricted. Meanwhile, a gray area has emerged between addressing clinical needs and ensuring regulatory compliance, characterized by the phenomenon of “policies from above, countermeasures from below.”

For example, when a child has a cold and fever, parents take them to the hospital for emergency care. They spend half the day traveling, parking, and waiting in line, only for the doctor to spend five minutes ordering a complete blood count (CBC) test. This not only disrupts the parents' daily work but also increases the child's risk of cross-infection at the hospital.

For another example, some clinics offer complete blood count (CBC) testing to patients in the community but lack the qualifications for a clinical laboratory. To circumvent this, they keep the testing equipment locked in a cabinet and only take it out when patients arrive. This practice not only carries the risk of penalties for regulatory non-compliance but, more critically, compromises the precision of CBC results under such usage conditions, thereby reducing the accuracy of diagnosis and treatment.

Addressing these societal needs for diagnostic and treatment convenience requires complete blood count solutions that are reliable in results and easy to use.Complete blood count (CBC) products that meet exemption requirements will be an effective solution path.

“The lifeline of medical testing products is to ensure quality first, and profitability second,” said Shi Wendian. “This is also the vision of CytoChip Inc.: to enable more people to access reliable and rapid medical diagnostic services.”

Reference 1:

URGENT CARE INDUSTRY WHITE PAPER

The Essential Nature of Urgent Care in the Healthcare Ecosystem Post-COVID-19