22 September 2021 - - US-based bio innovation studio IV BioHoldings (IVBH) has launched its bio innovation studio, debuting with a portfolio of three home-grown liquid biopsy companies, including LiquidLung, Inc., HepGene, Inc. and Mammogen, Inc, the company said.

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 launched its partnership with P4 Diagnostix, a specialist 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 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.

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 two years since launching LiquidLung, the first company to emerge from the studio, and one month after announcing the closing of a USD 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 220m Americans and over one bn people globally.

IVBH partnered with Liquid Biosciences, 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 is a non-invasive early detection, confirmatory diagnosis, and histological typing and subtyping of lung cancer.

HepGene is a non-invasive early detection of NAFL, classification of NAFL versus non-alcoholic steatohepatitis, and 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 is a 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.

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.

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.

P4 Diagnostix is a network of several nationally recognized testing and diagnostic facilities integrated into one unified lab services organization.

P4 is made up of companies including Theranostix, Long Island Pathology, Platinum Pathology, Metamark Laboratories and P4 Clinical.

P4's integration of diagnostic testing and office workflow is rooted in partnership with VitalAxis, an industry-leader in the delivery of healthcare informatics.