Initiate Ventures & Studio

Meet Michael Elashoff, founder and Co-CEO of Cornerstone AI. Mike has a strong background in biostatistics and data science, with degrees from UC Berkeley and Harvard. Prior to founding Cornerstone, Mike held positions with the FDA, Medidata, and Project Ronin. He also founded Patient Profiles (acquired by Medidata). At every step of his career, he's encountered the same issue time and again—the very manual, very time consuming, and very necessary task of cleaning data. This problem begged a question: what if this was a problem that could be solved? Learn more about Mike and the genesis of Cornerstone: https://lnkd.in/gfzGQ7gt #MeetTheTeam #DataScience #BioStatistics #DataCleaning #AI

City of Hope, the American Cancer Society and DELFI Diagnostics are launching a scientific collaboration utilizing DELFI’s FirstLook Test to help improve lung cancer screening rates in underserved LA County communities. Lung cancer is the leading cause of cancer deaths domestically and globally. Yet, only six percent of eligible individuals in the U.S. get screened and, in California, this statistic drops to 0.7 percent. Read more about this investigator-led study here: http://tiny.cc/yi7mxz #earlycancerdetection #earlydetectionsaveslives #cfdnafragmentomics

Today, we’re pleased to announce the availability of our fragmentome-based research use only (RUO) cancer monitoring assay, DELFI-Tumor Fraction, as we enter a collaboration with Immunocore. This research collaboration will explore our cancer monitoring assay, a highly sensitive, inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer, as an early predictor of benefit from treatment with Immunocore's ImmTAC-based therapies. It’s an exciting moment for DELFI as we get to work with the Immunocore team in further investigation of the potential of our liquid biopsy platform. Read and learn more below.

We are thrilled to officially introduce FirstLook Test, an accessible, accurate way to enhance #lungcancer detection through a routine blood test. Lung cancer is the #1 cancer killer in the U.S. and globally. As a #liquidbiopsy test designed for those eligible for #lungcancerscreening, FirstLook is an important tool for the #futureofhealth, capable of conveniently being initiated in #healthcare provider offices or laboratories to help determine the next best step in the lung cancer screening process. This test uses fragmentomics and advanced #machinelearning technology to compare an individual’s cell-free DNA patterns and characteristics in the blood against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify the majority of people who will have lung cancer identified by low-dose CT scan, including early-stage disease. Beginning this fall, FirstLook will be available with select health systems in the U.S. through our Early Experience Program (EEP). Learn more about FirstLook and upcoming events like #HLTH2023 in the full release: https://lnkd.in/drfb2RJP

FDA RELEASES REGULATIONS TO CONTROL LDT's On September 29, 2023, FDA released an 80-page proposed regulations to control lab-developed tests, using the traditional Class II and Class III regulations (510k, PMA). Comment is due in 60 days. FDA also issued a press release. FDA states its concerns include both (1) test performance and (2) marketing claims. The regulatory approach is extremely concise, simply by adding a few words to the definition of IVD devices (including those "manufactured by a laboratory.") The FDA also includes lengthy legal justification, and offers a roll-in period of about 3-4 years. I've put links and discussion in a blog which I will update as other news reports or press releases appear in the next day or two. #FDA #LDT #REGULATION #INNOVATION https://lnkd.in/gPUj-kX4