“Giving Cancer Patients New Hope”

Cha-Mei Tang, Founder, President, and CEO of Creatv MicroTech believes that scientific research and technical development must be performed correctly and accurately. “I believe in putting forth the best effort in supporting creativity. The creativity of one employee lead to our high quality microfilter that collects cancer cells and cancer associated cells from the blood of cancer patients and eliminates red blood cells and 99.9% of white blood cells,” she says proudly. “This filter not only allows for rapid manufacturing, but also provides high quality images of the cells.” This focus on accurately identifying and collecting not only well-recognized circulating tumor cells, but also lead to the discovery of a unique biomarker, termed Cancer Associated Macrophage-like Cells (CAMLs), that turned out to have very broad clinical applications.

"Creatv, founded by Cha-Mei Tang, developed LifeTracDxTM blood tests with broad spectrum of clinical applications – detecting and diagnosing cancer in the earliest stages, when it matters the most, thus improving therapeutic outcomes and saving lives."

Cha-Mei Tang received her BS, MS, EE, and ScD degrees from the Electrical Engineering and Computer Science Department of MIT. When she was a graduate student, she began to think about what she wanted to do with her life. “I was interested in all kinds of science, business, finance, marketing and even law. I decided that I would start with performing research and work in some aspects of business, and maybe becoming an artist. I was a theoretical physicist focusing on relativistic electron beams for 18 years after graduate school. I also took two business law classes right after graduate school. When the opportunity to start a company presented itself, I took it immediately, because it was part of my life plan. So, I recommend everyone to have a long-term plan on what they want to do with their life,” explains Cha-Mei.

When she initially founded the company, she was very interested in the fabrication of high-aspect-ratio microstructures. Hence, “MicroTech” is in the name of the company. “Since I was located in Maryland and surrounded by drug and diagnostic companies, NIH, FDA, NIST, Johns Hopkins University and University of Maryland School of Medicine, I was inspired to contribute to the biomedical field,” she explains. “Initially, we performed some cutting edge research and development, but failed to address the pain points. Now I understand that good research alone does not lead to a successful company; you need to solve an important problem and consider the market potential. Our current LifeTracDxTM cancer test has greater market potential than we could have even dreamed.”

Cha-Mei and her team of researchers are detecting and diagnosing cancer in the earliest stages, when it matters the most, improving therapeutic outcomes and saving lives. This

requires Creatv’s high quality CellSieveTM microfilter and identification of CAMLs and CTCs collected from cancer patients’ blood samples. Most of the time, there are no CTCs present in sufficient quantities to measure, except for late stage of breast, prostate and colorectal cancers. However, CAMLs are found in 21 types of solid tumors samples, and in all stages of cancer.

For Creatv, the near term plan consists of three parts, (1) setting up a CLIA lab to process patient samples, (2) automate blood sample processing and develop artificial intelligence to read the slides, and (3) conduct a pivotal trial for FDA approval for predicting treatment response for unresectable stage III non-small cell lung cancer (NSCLC). Creatv also intends to apply for concurrent CMS review for reimbursement. “Lung cancer causes 25% of all cancer deaths in the United States. Immunotherapy can benefit about 25% of these patients, but is a very expensive process. If the patient is not responding, the patients should not continue to suffer the side effects, or pay the high cost,” says Dr. Tang.

The longer term applications of LifeTracDxTM tests are very broad. LifeTracDxTM has demonstrated clinical capabilities for (1) screening for cancer for a single cancer or many different cancers simultaneously, (2) providing companion diagnostics for a broad spectrum of therapies without tissue biopsy, (3) providing prognosis at any time point, (4) predicting treatment response within 30-60 days for any therapy, (5) determining residual disease at the end of therapy, (6) enabling early detection of recurrence, and (7) collecting high quality tumor DNA for molecular analysis to detect mutations, translocations, and methylations.

These capabilities are also very helpful for drug development, and we are currently supporting a number of drug development clinical trials, by identifying the presence, size, expression of the marker of interest in the CAMLs.

Because of the vast spectrum of applications, we look forward to collaborations and partnerships with others to bring LifeTracDxTM tests to market not only in the United States, but also around the world.IE