Dr. Cha-Mei Tang, Creatv Bio Founder, President, and CEO: “Operating in high-risk areas such as cancer screening and diagnostics demands unwavering ethical commitment and meticulous risk management. Creatv Bio places the utmost value on delivering accurate, reliable science.”

 

Dr. Cha-Mei Tang’s journey from the abstract world of theoretical physics to the cutting edge of cancer diagnostics is a story of bold vision and scientific curiosity. As the founder, president, and CEO of Creatv MicroTech, she leads groundbreaking work at the intersection of science and medicine through its oncology division, Creatv Bio. A trailblazer with a BS, MS, and ScD from MIT, Dr. Tang began her career at the Naval Research Laboratory, researching free electron lasers and relativistic electron beams. In 1996, she founded Creatv MicroTech in Maryland, originally focusing on x-ray imaging technology. By 2000, she had reincorporated the company in Delaware, expanding its mission to include biomedical innovation.

Though her early work revolved around mathematical models and high-energy physics, Dr. Tang’s passion for exploring new scientific frontiers led her to shift toward life sciences. “I’ve always been fascinated by the spectrum of science,” she reflects. That curiosity eventually inspired the launch of Creatv Bio, a division dedicated to transforming cancer care through advanced diagnostics, treatment monitoring and screening (https://creatvbio.com/). Today, Dr. Tang stands at the forefront of a field where her analytical mind and entrepreneurial spirit are helping to redefine how we detect and treat cancer.

Pioneering Next-Generation Cancer Diagnostics

Creatv Bio has developed a suite of services that are both scientifically rigorous and clinically transformative. Initially, the company provided specialized blood tests to cancer drug companies. These tests play a pivotal role in clinical trials, offering insights into the efficacy of novel cancer therapies under Institutional Review Board (IRB) supervision. Looking ahead, Dr. Tang envisions an expansion that will bring groundbreaking diagnostics directly to oncologists and their patients. With planned applications for CLIA and CAP lab approvals at its state-of-the-art facility in Monmouth Junction, New Jersey, Creatv Bio aims to process patient samples, thereby transitioning from being a tool for drug developers to a frontline companion in clinical oncology.

The Technological Breakthrough: LifeTracDx®

At the core of Creatv Bio’s success is its proprietary assay, LifeTracDx^® Liquid Biopsy, a technology born of passion, perseverance, and technical brilliance. The blood test leverages two breakthrough innovations: the CellSieve^™ microfilter and the discovery of Cancer-Associated Macrophage-like Cells (CAMLs).

The CellSieve™  Microfilter

Creatv Bio’s journey began with a deep-rooted experience in microfabrication—a skill honed during Dr. Tang’s rigorous scientific career. The CellSieve^TM microfilter is meticulously engineered to capture circulating tumor cells (CTCs) from blood. Featuring 180,000 pores, each only 7–8 microns in diameter, the filter is designed to process blood samples rapidly, processing 7.5 ml of whole blood mixed with 7.5 ml of fixation buffer, total 15 ml, within three minutes. By removing all red blood cells and 99.99% of white blood cells, the device isolates cells larger than 10 microns—often the domain of cancer cells or clusters thereof—onto its surface. Crucially, the low background autofluorescence of the filter allows for high-quality imaging after the cells are stained with fluorescent biomarkers. This technological leap not only ensures precision but also accelerates the turnaround time, a critical factor when monitoring cancer therapy responses.

Discovery of CAMLs

During early sample analyses, Creatv Bio’s research team encountered an unexpected phenomenon. “We were initially looking for CTCs,” Dr. Tang explains, “but instead, we found many giant, strangely shaped cells that defied conventional classification.” Detailed analysis by Chief Scientific Officer Daniel Adams revealed that these cells were not traditional tumor cells; rather, they were a unique cell type expressing macrophage markers. These cells, later named Cancer-Associated Macrophage-like Cells (CAMLs), typically range from 25 to 300 microns and exhibit unusual physical attributes such as polynucleation and elongated tails. Found in blood samples from over 30 different tumor types and even in early-stage cancers, CAMLs represent a universal biomarker that distinguishes themselves by their absence in healthy individuals.

The discovery of CAMLs was groundbreaking. Their presence across various cancers suggested that they could serve as indicators of disease, helping to diagnose cancer early, monitor treatment response, and even predict patient prognosis. Creatv Bio’s scientific journey—from initial surprise at their appearance to extensive research confirming their significance—embodies the relentless spirit of innovation that has come to define the company.

Enhancing Precision Medicine Through Liquid Biopsy

Traditional methods of evaluating treatment efficacy—primarily through imaging—face significant drawbacks. Imaging techniques often require months to detect changes in tumor size or behavior, delaying critical treatment decisions. More invasive tissue biopsies, while informative, carry risks and are not easily repeatable. In contrast, LifeTracDx^® offers a dynamic solution that integrates seamlessly into precision medicine. With its ability to deliver high-quality DNA for sequencing and track treatment response within a mere 30 days, the test provides oncologists with real-time data, enabling timely adjustments to therapeutic regimens.

(Comments on the figures: 

• CTCs are small cells. The image of CTCs is too big. Make the image of CTCs half the size as shown in the pdf draft. 
• CAMLs are very large cells. You can make the image larger if you have space.)

In pivotal clinical trials involving metastatic breast cancer, Creatv Bio’s assay demonstrated its value. Data from a study with BriaCell Therapeutics Corporation revealed that a reduction in CTC and CAML counts or CAML sizes was significantly correlated with improved Progression Free Survival, and even hinted at an association with Overall Survival. The study also illuminated how treatment of a cancer vaccine in combination with an immunotherapy drug benefited from the immunotherapy. High PD-L1 expression on the tumor is a marker for predicting response to immunotherapy. By staining cells for the PD-L1 marker, LifeTracDx^® blood test not only confirmed the treatment’s effect but also provided valuable insights on PD-L1 expression of the tumor. LifeTracDx^® showed that the cancer vaccine changed many patient’s PD-L1 expression from low to high, and those patients benefited from immunotherapy.

Bridging the Gap Between Scientific Innovation and Clinical Practice

Creatv Bio’s vision extends far beyond the laboratory. The company is meticulously crafting a roadmap to integrate its liquid biopsy technology into standard oncology practice. One of the foremost challenges in the biotech world is ensuring that breakthroughs are not only scientifically valid but also commercially viable. Dr. Tang acknowledges that scalability in biotech is a formidable hurdle, yet she is optimistic. “Our LifeTracDx^® blood test is scientifically groundbreaking,” she asserts. The assay is applicable across multiple cancer types and stages, serving three major screening roles: early detection of cancer, assessing minimal residual disease after treatment, and detecting cancer recurrence well before it becomes visible through conventional imaging techniques.

To secure its place in the market, Creatv Bio is deploying a multi-pronged strategy. The company is ramping up marketing initiatives aimed at increasing awareness among oncologists and patients alike. A significant milestone on the horizon is obtaining the necessary FDA approvals; the company plans to file for three distinct approvals covering the test’s prognostic use, treatment response prediction, and companion diagnostics capabilities—specifically related to PD-L1 expression for immunotherapy. Furthermore, securing reimbursement from major payors such as the Centers for Medicare and Medicaid Services (CMS) and private insurers is critical to ensuring broad market adoption. These steps are not only strategic business decisions but also reflect the company’s commitment to transforming cancer care on a global scale.

Ethical Responsibility and Risk Mitigation in High-Stakes Innovation

Operating in high-risk areas such as oncology demands unwavering ethical commitment and meticulous risk management. Creatv Bio places the utmost value on delivering accurate, reliable science. By adhering to rigorous standards of research quality and ethical responsibility, the company has established safeguards that ensure its innovations not only push the boundaries of what is possible but also protect patient interests. “Good science and accurate science will provide safeguards and ensure ethical responsibilities,” Dr. Tang emphasizes. This guiding principle has been critical in driving the long-term success of Creatv Bio, bolstering its reputation among clinicians, researchers, and investors alike.

Strategic Decisions: Balancing Innovation and Market Realities

A critical component of Creatv Bio’s strategy has been its agility in balancing scientific breakthroughs with commercial imperatives. The company’s ability to pivot—from initially serving as a microfabrication company to positioning itself as a cancer diagnostic powerhouse for a wide range of cancer applications—illustrates this balancing act. By investing over a decade into understanding the clinical applications of CAMLs, Creatv Bio has created an assay that bridges a significant gap in oncology diagnostics. The LifeTracDx^® blood test now offers the capacity to perform complex analyses using a simple blood draw, thereby reducing patient discomfort and cost, while simultaneously providing oncologists with a robust tool to monitor and adjust treatment in near real-time.

This ability to harness scientific innovation while addressing market needs has attracted significant interest from both pharmaceutical partners and the broader scientific community. Collaborations with leading cancer drug companies have not only validated the clinical importance of Creatv Bio’s technology but also provided valuable real-world data that paves the way for further regulatory approvals and wider adoption.

The Road Ahead: Expanding Horizons and Deepening Impact

Looking at the future, Dr. Tang’s vision remains as ambitious as it is clear. Creatv Bio is in the advanced stages of establishing a CLIA laboratory that will enable direct processing of patient samples, thus streamlining the transition from clinical trials to day-to-day diagnostic applications. The company’s upcoming FDA approval applications and ongoing participation in further clinical trials—such as the current study on colorectal cancer—signal exciting times ahead. These initiatives are poised not only to fortify Creatv Bio’s scientific platform but also to create new revenue streams and broaden the reach of precision oncology.

Moreover, Creatv Bio’s work has broader implications for the field of precision medicine. By offering a test that can detect cancer recurrence months before conventional imaging and provide detailed insights into tumor biology, the LifeTracDx^® blood test represents a paradigm shift in cancer diagnostics. The use of CAMLs as a biomarker across all tumor types underscores the potential for a universal diagnostic tool, one that could simplify the complex landscape of cancer detection and monitoring therapy.

“The LifeTracDx^® blood test now offers the capacity to perform complex analyses using a simple blood draw, thereby reducing patient discomfort and cost, while simultaneously providing oncologists with a robust tool to monitor and adjust treatment in near real-time.”