While there have been significant advances in treating cancer, it is forecasted that cancer rates will increase by more than 50% and death rates will almost double in the next twenty years. Currently, cancer screening is available for specific forms of cancer such as breast, colon, prostate, lung, and others. These tests can only detect the cancer once it has formed in the body and begun to take hold. They do so by imaging a specific area, which requires significant human touch to identify, gather, and assess. Additionally, cancer tests are expensive and generally not ordered unless there is a known risk. 

Advances in cancer treatment have dramatically reduced the number of fatalities, but the key to this is early detection. The earlier the cancer is detected the higher the probability of beating it.

It is widely believed that cancer can begin developing in the body as early as 12 years before clinical symptoms appear. What if there were a simple blood test that could detect cancer when it was at the minute cellular level before it caused any problems?

Delee has created CrytoCatch, which uses a blood sample to detect 1 tumor cell out of 37.5 billion blood cells. This small machine initiates a rapid process in as little as 15 minutes to isolate a single tumor cell, thus identifying the start of cancer unimaginably early.

How is this possible?

In the majority of cancers, when a tumor develops, even if it is still localized, it releases malignant cells into the bloodstream, called circulating tumor cells (CTC). These cells have a key role in the establishment of metastasis in other organs.

CytoCatch is on track to be the second FDA approved CTC test by 2023. It will be the first for early detection of cancer, and it will provide valuable feedback for increasing the efficacy of cancer treatments. Prior to FDA clearance, CytoCatch will be marketed as a powerful research tool for pharmaceutical companies and researchers to improve their cancer treatment research.  

CTC, the core technology in CytoCatch, was first given Current Procedural Technology codes at the beginning of 2013. Those codes are necessary to bill Medicare and insurance companies. CellSearch received FDA approval for its CTC technology in 2004 for monitoring metastatic breast cancer. It has gained further FDA approval for monitoring very specific cancer treatments. CellSearch, like the majority of CTC research, is used to evaluate the progress of a patient’s cancer treatment. This technology enables a more comprehensive assessment of whether the cancer is shrinking or growing after the cancer has been identified through clinical symptoms.  

Currently, CellSearch remains the only FDA approved CTC product on the market. There is no indication of a direct competitor to CytoCatch, which is focused on identifying cancer long before any known test.

Liza Velarde, CEO, and Co-Founder – Ms. Velarde’s charisma leaps through the phone. She has a passion for her company and is quick to identify gaps she and her co-founders have and how she has been able to access experts to fill those gaps. 

She started Delee while finishing her degree summa cum laude at Tecnologico de Monterrey. According to Delee’s marketing, Ms. Velarde is responsible for creating the company’s relationships with hospitals and research institutions. She was awarded the prestigious Cartier Women’s Initiative Award and the WeXchange. In 2019, she also co-founded Zen Fluidics, a line of products to empower researchers to develop unique microfluid applications.

• Model: Delee is uniquely positioned for revenue pre-FDA and post-FDA approval. The post-FDA approval is the most lucrative part of Delee’s business model, but it is noteworthy for Delee’s innovation to have revenue before FDA approval.
  • Delee will sell the CytoCatch machine to researchers prior to FDA approval. In addition to the sales price of the machine, Delee will gain revenues via sales of the necessary reagents and consumables to perform each test.

• Y Combinator (YC): Delee was part of the YC program in 2017. YC is the most prestigious American seed accelerator. Participants move to the Bay Area for three months where they are run through a boot camp with mentors from industry. YC has launched over 2,000 companies with high profile alumni such as Stripe, Airbnb, Cruise Automation, DoorDash, Coinbase, Instacart, and Dropbox. The incubator has an acceptance rate of 1.5%.

• Market Gap: Delee’s strategy is to attack cancer detection before there are any clinical symptoms. This innovation is a market gap many do not have the imagination to pursue. Further, Delee intends to begin testing for prostate cancer first. This focus will be a significant step in cancer treatment because, according to Ms. Velarde, women’s cancer is currently the only one with an early detection test. Providing a male cancer screening will be a significant step for male cancer treatment and will further differentiate Delee’s product.

• Clinical Trials: To save money on costly clinical trials, trials will be conducted in Monterrey, Mexico. Delee will pursue United States FDA approval but all testing and engineering will occur in Mexico, allowing significant cost savings.

“Cancer is curable, the problem is the lack of timely information.” – Ms. Velarde 

Ms. Velarde has the type of drive and vision to realize the seemingly impossible with CytoCatch. While she was still at University, during an elevator ride, she pitched Delee to the Heineken CEO Jean-Francois van Boxmeer and convinced him to donate funds to the first prototype.

The Delee team is using an almost twenty-year-old technology, CTC, which never gained the expected promise with still only one FDA approved product in the market. While cancer treatment is a very crowded market, diagnosis before clinical symptoms is not. This young, energetic team might just have the formula to radically change cancer.