IV BioHoldings Debuts Liquid Biopsy Portfolio; Partners with P4 Diagnostix to Scale Commercialization of Non-Invasive Lung, Liver and Breast Diagnostics

IV BioHoldings (IVBH) has announced today the public launch of its bio innovation studio, debuting with a portfolio of three home-grown liquid biopsy companies, including LiquidLung, Inc., HepGene, Inc. and Mammogen, Inc. Collectively, the IVBH companies comprise eight clinical-ready diagnostics, spanning the care continuum for lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer, respectively.

IVBH has also announced today its partnership with P4 Diagnostix® (P4), a leader in diagnostic pathology, to fast-track commercial efforts of molecular diagnostic tests and meet clinical demand for earlier, easier and more precise detection, diagnosis and treatment of pulmonary, metabolic, and women's health disease. Offering best-in-class testing services and proprietary healthcare informatics, P4 will serve as the exclusive laboratory partner for all clinical assay development and clinical validation across the lung cancer, NAFLD and breast cancer programs for each of the IVBH companies.

“What we’re seeing out of the IVBH ecosystem is platform test development capabilities that are years ahead of traditional test development in the liquid biopsy space, representing an opportunity for P4 to get on the ground floor of this dynamic area of molecular medicine,” said Marcus Cognetti, Co-Founder of P4. “By partnering across the IVBH portfolio, we’re providing an industry-first opportunity to scale the speed and rate at which non-invasive diagnostics are made available to the millions of people for whom this testing is not available or are underserved by the existing standards of care. The novelty of the science, strength of the data, and competitive intellectual property built around these existing indications is quite astonishing, and is a testament to the efficiency of the IVBH business model and its progressive approach to R&D.”

IVBH was founded in 2018 by Marty Keiser, with the vision of dramatically reducing the time, cost and risk associated with healthcare innovation through unique applications of data analysis using advanced technology. Its business model was purpose-built to accelerate value creation of novel intellectual property by allowing each of its disease-specific companies to leverage shared resources and tap into strategic partnerships formed by the studio.

In just over two years since launching LiquidLung, the first company to emerge from the studio, and one month after announcing the closing of a $2M seed round at its women’s health startup, Mammogen, the studio has now emerged from stealth with its portfolio of intellectual property positioned to address unmet clinical needs for 220 million Americans and over one billion people globally.¹

IVBH partnered with Liquid Biosciences (LBS), whose Emerge bio-analytics platform has been radically reducing diagnostic and drug development time, cost and risk for a decade. IVBH and LBS collaborated on novel biomarker discovery and validation to develop the following liquid biopsy solutions:

• LiquidLung, Inc. – Non-invasive early detection, confirmatory diagnosis, and histological typing and subtyping of lung cancer. In a study conducted in peripheral whole blood for lung cancer detection, the technology achieved 97% sensitivity, 85% specificity, including 100% detection of patients with stage I lung cancer, without the use of any demographics, clinical risk-factors, or radiological data.
• HepGene, Inc. – Non-invasive early detection of NAFL, classification of NAFL versus non-alcoholic steatohepatitis (NASH), and definitive diagnosis of NASH. HepGene’s technology was validated across a diverse range of tissue types and biofluids (including blood), achieving 92% sensitivity, 97% specificity for early detection of NAFL and 94% sensitivity, 86% specificity for definitive diagnosis of NASH. The company IP also includes a proprietary portfolio of promising novel therapeutic targets for the treatment of NASH, which emerged from robust in vivo analysis of diseased patients and is supported by strong proof-of-principle that establish and validate biological plausibility.
• Mammogen, Inc. – Non-invasive early detection and confirmatory diagnosis of breast cancer. Mammogen’s core technology, validated across peripheral blood mononuclear cells as well as saliva, is initially geared towards women under 40 and women over 55, two populations of women who are underserved by existing screening guidelines and current standards of care for breast cancer. Optimizing for women under 40, Mammogen’s technology achieved 93% sensitivity, 97% specificity. Optimizing for women over 55, the technology achieved 97% sensitivity, 87% specificity. Results were achieved without the use of any demographics or clinical risk-factors.

The introduction to P4 was made by Elizabeth Cormier-May, CEO of Mammogen and commercialization expert within the inner echelons of the IVBH studio, who has had a longstanding working relationship with the molecular lab throughout the course of her near twenty-year career in diagnostics.

“P4’s repeated success in diagnostic commercialization, seven CLIA certified laboratories strategically located across the US, and its proprietary IT solutions enabling electronic health record (EHR) integration, ensures that our clinical and commercial phases of development will be consistent with the efficiency of our model, making them the ideal partner for IVBH,” stated Cormier-May.

“What normally takes the diagnostics industry at least six years to accomplish on a per product basis, we did for eight clinical-ready diagnostic products in just over two years,” said IVBH founder and CEO Marty Keiser. “There’s no question that accelerated R&D timelines, and the corresponding reduction in risk associated with over 200 novel scientific discoveries across the lung, liver and breast programs, were a direct result of IVBH’s powerful partnership model and intentional application of exponential technologies such as that of our partners at LBS. With the addition of P4, we’re able to progress from R&D to commercialization with the level of speed, efficiency and quality that all human beings deserve.”

IVBH is now scaling to support its flagship lung, liver and breast programs through clinical development and commercialization. Other plans on the horizon include a focus on pipeline expansion across pulmonary, metabolic and women’s health disease, and incubation of future company creations.

For more information on IV BioHoldings, visit www.ivbh.studio. To explore partnership opportunities, email [email protected].

¹https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening, https://www.the-nash-education-program.com, https://www.statista.com/statistics/241488/population-of-the-us-by-sex-and-age/

About IV BioHoldings

We are a bio innovation studio specializing in de novo company creation at the intersection of diagnostics and life sciences. We take a multi-disciplinary approach to building companies; cross-pollinating ideas and experience across a variety of industries, breaking down silos, upending the healthcare R&D process, and rethinking the startup model. We leverage powerful partnerships and advanced analytical science to provide greater insight into human biology in order to radically improve the detection, diagnosis and treatment of disease. The current IVBH ecosystem comprises three transformative bio startups, including LiquidLung, Inc., HepGene, Inc., and Mammogen, Inc., focused on pulmonary disease, metabolic disease, and women's health, respectively. For more information visit www.ivbh.studio.

About P4 Diagnostix®

P4 Diagnostix® is a network of several nationally recognized testing and diagnostic facilities integrated into one unified lab services organization, offering clients unparalleled access to connectivity, healthcare resources and consultative partnerships. P4 is made up of these industry-leading companies: Theranostix, Long Island Pathology, Platinum Pathology, Metamark Laboratories and P4 Clinical. P4's progressive integration of diagnostic testing and office workflow is rooted in partnership with VitalAxis, an industry-leader in the delivery of healthcare informatics. For more information visit www.p4dx.com.

About Liquid Biosciences

Liquid Biosciences radically reduces diagnostic and drug development risk, time, and cost, from pre-clinical research through regulatory approval. Our Emerge bio-analytics platform agnostically discovers and models the nonlinear dynamics of how biology, behavior, and circumstances interact to drive patient outcomes. Our mathematical evolution technology goes beyond artificial intelligence's capabilities, and has produced superior accuracy, novel insights, and explainability in every head-to-head comparison with other analytic methods. Liquid Biosciences' clients are major biopharma firms, diagnostic companies, and world-class research institutions. We've completed over 180 major analytic projects across 45 diseases, using the full spectrum of clinical trial, real-world, and multi-omics biomarker data. For more information about Liquid Biosciences, visit www.liquidbiosciences.com.

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