Prescient Metabiology Submits IPO Prospectus Following FDA Breakthrough Device Designation for LifeKit Prevent, a Non-Invasive Colorectal Cancer Diagnostic

On September 11, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Prescient Metabiology’s medical device, LifeKit Preven, had received FDA Breakthrough Device designation for the detection of early-stage colorectal cancer.

Colorectal cancer (CRC) is one of the most common cancers in the United States, with more than 130,000 new cases and approximately 50,000 deaths each year. Healthcare institutions across the country perform over 14 million colonoscopies annually, and the cost of CRC diagnosis and treatment exceeds $14 billion. However, data show that two-thirds of Americans disregard CRC screening guidelines, and 60% of CRC cases are not diagnosed until the disease has reached an advanced stage.

LifeKit Preven is the first non-invasive diagnostic device for colorectal cancer to receive FDA Breakthrough Device designation, primarily used for detecting precancerous polyps and diagnosing early-stage colorectal cancer. Unlike other non-invasive screening tools on the market, this device does not rely on colonoscopy and can directly detect precancerous adenomas in patients.

Prescient Metabiology, a subsidiary of Prescient Medicine Holdings, is dedicated to the development of advanced molecular diagnostic technologies. Currently, the company is developing in vitro diagnostics, non-invasive disease screening, and health examination technologies, while leveraging high-throughput sequencing to advance research in systems biology and human microbiome science.

Non-invasive testing devices increase patient adherence to colorectal cancer (CRC) screening programs. It is estimated that promoting CRC screening could save more than 10,000 lives annually across the United States.

Clinical studies have demonstrated that LifeKit Prevent is highly accurate in detecting colorectal cancer (CRC) and precancerous adenomas, and may offer greater convenience and reliability compared to existing CRC diagnostic technologies. Diagnostic results from this device will encourage treatment-resistant, high-risk patients to undergo colonoscopy, enabling the screening of precancerous adenomas and preventing their progression to malignancy, thereby reducing the incidence and mortality of CRC.

Prescient Medicine, founded in 2014 and headquartered in Pennsylvania, USA, is a medical device company. The company focuses on developing diagnostic and therapeutic tools for diseases to advance the field of precision medicine.

Prescient Medicine aims to accelerate the development of the healthcare industry through advanced clinical diagnostic technologies, addressing urgent public health challenges in the United States. With keen insights from its leadership team, the company’s products leverage data analytics and other methods to assist physicians in making detailed clinical decisions, thereby improving patient clinical outcomes.

Prescient Medicine operates three CLIA-certified laboratories and possesses advanced drug screening tools, ToxKit, and pharmacogenomic testing technology, LifeKit PreScript. Furthermore, the company collaborates with its subsidiary, AutoGenomics, to develop the in vitro diagnostic technology LifeKit Predict for the diagnosis and treatment of patients with opioid dependence.

Keri Donaldson, M.D., of Prescient Metabiology, stated, “The FDA’s Breakthrough Device designation is a testament to our unique technology. LifeKit Prevent is a non-invasive diagnostic testing device that not only accurately detects colorectal cancer (CRC) but also aids in the identification of patients with advanced adenomas.”

(Compiled by Xu Xiaoxue)