Prodrome-CRC launch – the high-resolution/accurate mass blood test to assess colorectal cancer risk

Prodrome Sciences is proud to announce the commercial launch of Prodrome-CRC – the high-resolution/accurate mass blood test for assessing colorectal cancer risk. Prodrome-CRC is a simple blood test that requires no advance preparations and no fecal handling. The multi-analyte test accurately determines if a person has a Gastrointestinal Tract Acid (GTA) deficiency, a validated risk factor for colorectal cancer. A simple, accessible blood test such as Prodrome-CRC has the potential to increase colorectal cancer testing compliance leading to earlier disease detection when the cancer is easier to treat.

The association between low blood levels of GTAs and an increased risk of colorectal cancer has been validated in numerous international clinical trials. Due to technical limitations, first generation GTA blood tests used low resolution technology (triple-quadrupole mass spectrometry) and measured only a single GTA biomarker (GTA-446) to represent the entire family of GTA biomarkers that are known to be decreased in colorectal cancer patients. Prodrome-CRC is an advanced multi-GTA biomarker test which uses high-resolution/accurate mass technology to simultaneously measure multiple important GTA biomarkers. Prodrome-CRC incorporates Prodrome Sciences’ advanced multi-analyte technology to accurately assess the overall GTA level in blood. Prodrome Sciences’ multi-analyte technology reduces the risk of false positive and false negative determinations of a GTA deficiency that may occur when only the single GTA-446 biomarker is used to assess the large family of GTA biomarkers in blood.

Colorectal cancer is the second leading cause of death from cancer in the USA. Less than 30 percent of persons comply with recommended screening tests (colonoscopy or fecal testing) primarily due to the unpleasantness of the procedures. Most cases are detected at a later stage when the cancer is advanced enough to make the person feel sick. More than half of the persons who will die of colorectal cancer this year would be alive next year if only their cancer was detected earlier. A simple, accessible blood test such as Prodrome-CRC is a critical first step to reduce colorectal cancer deaths by incentivizing high-risk persons to undergo potentially life-saving colonoscopy to see if an early stage tumor is present. Complete recovery from colorectal cancer is expected if detected early. Knowing disease risk is also an important first step for promoting and targeting preventative measures such as diet and lifestyle changes in high-risk persons.

Dr. Dayan Goodenowe, Prodrome Sciences’ Founder and CEO and the inventor and patent holder of the high-resolution/accurate mass technology originally used to discover the association between colorectal cancer and low GTA biomarkers, explains the new Prodrome Sciences tests: “when my laboratory first discovered the association between GTAs and colorectal cancer, the multi-analyte high-resolution/accurate mass measurements consistently outperformed the low-resolution single-analyte measurements, as described in various patent filings; however, it was just not viable to launch a commercial high-resolution/accurate mass-based test with the technology available at that time. The development of the single analyte GTA-446 biomarker test was an important first step for blood GTA analysis and was the best that we could do at the time. I am excited to finally be able to unleash the powerful high-resolution/accurate mass technology that had previously been constrained to only research and discovery applications. Prodrome-CRC represents the first of many commercial diagnostic products that we will be launching using the new high-throughput, high-resolution/accurate mass platform.”