Molecular Diagnostics: defining the leading edge of health care innovation


Bonnie Anderson, CEO of Veracyte, and Winnie Wan, CEO of OncoHealth shared phenomenal success stories at EPPIC meeting www.eppicglobal.org on April 28, 2011.

Highlights from Anderson’s presentation

Veracyte technology focuses on diagnostics for thyroid cancer disease that has high rate of ambiguous diagnostic test results.  About 30-40% of patients receive inconclusive results.  According to current guidelines, these patients are referred for surgery, although majority of these cases end up being benign, resulting in cost to the healthcare system of over $1 B.  Veracyte, Afirma Thyroid FNA Analysis offers an improved solution to better assess thyroid nodules and more accurately separate benign from malignant classifications.  Veracyte’s molecular tests are designed to clarify ambiguous results obtained from cytology samples, resulting in fewer unnecessary biopsies and less anxiety for the patients and huge savings to the healthcare system, saidAnderson. Andersonshared the milestones from the original concept to achieving impressive feat of Series A funding for $20 M in February, 2008.  The company then focused on collecting samples in large, multicenter clinical studies comprising of academic and community sites.  In 2009, the focus was on developing powerful machine-learning algorithms and sophisticated statistical approaches to make sensibly sort out the large amount of genomic data to enable most accurate diagnosis possible.  They got great results from gene expressions.  In September of 2009, the gene expression discovery was completed and they implemented comprehensive laboratory process analytical validation studies and by mid 2010, the company was able to show conclusive results with 95% accuracy.  The focus was turned to market development.  During the recession year of 2010, Veracyte achieved another impressive feat and closed Series B round of funding for $28 M.  Now the company is focusing on the next indicator, the lung.

Highlights from Wan’s Presentation

OncoHealth focuses on enhancing women’s health through more accurate cervical cancer diagnosis.  Each year, over 4 M women receive abnormal pap test results leading to great anxiety and fear and unnecessary repeat testing, coloscopies, and biopsies result in unnecessary cost to the healthcare system of over $2B.  OncoHealth technology is centered around proprietary HPV E6E& protein detection system.  HPV contributes to cancer development through E6E& oncogenes.  These oncoproteins inactivate tumor suppressor genes.  In precancerous and cancerous lesions, E6 and E7 are expressed at much higher levels than found in benign lesions.  OncoHealth has developed different format of testing, including a solution-based ELISA assay that can be done in a high throughput robust system approach.  Their technology is protected by 1 issued, 1 allowed, and 17 pending patents, and has a worldwide market potential of $5.8 B said Wan.  OncoHealth aims to introduce ELISA and ICC tests with existing clinical lab practices for Pap test sample collection whereby Cytopathology labs can derive additional revenue without additional capital expenditures.  OncoHealth tests will be integrated initially with different instrument platforms, including microscopy, flow cytometry, ELISA, and point-of-care systems.  OncoHealth has raised initial funding of $1.6 M from Angel syndicate.  OncoHealth is in the midst of a comparative stud with NCI and Lab Corp. to study 2000 blinded clinical samples provided by them, equivalent to $3 M grant-in-kind.  OncoHealth is aggressively pursuing achievement of key milestones and has a vision to leverage its proprietary technology to produce a full product line of unique test applications for other HPV-associated cancers, including anal, oral, laryngeal, vulva, penile, and vaginal cancers.

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  1. penile cancer

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