Helomics : Clinical Testing :
Testing Information

Testing information and ordering

Clinical test catalog and ordering information:

  1. Contact our Client Services team via phone, email, or using the contact form on our site. Our representative will ask you for shipment information and send a specimen collection kit to your facility.

  2. Obtain the patient’s signature on Helomics’ Universal Informed Consent Form.

  3. Immediately after the patient’s surgery, follow the specimen submission instructions to secure the patient specimen in the collection kit and ship it to the Helomics lab. Include the completed requisition form found inside the kit and a patient face sheet, if available.

Specimen acceptance criteria:

For Helomics testing, all samples submitted to Helomics must be properly labeled with 2 unique patient identifiers to avoid rejection upon receipt.

Tumor drug response testing:

  • Only provides results on confirmed gynecological tumors.
  • Specimen must be fresh tissue shipped in growth medium provided
    in Helomics’ standard tumor profiling kits.
  • Pathology report or confirmed gynecological diagnosis from the
    ordering physician received for the submitted sample.
  • Acceptable signature and date on the order form.
  • Complete patient demographics and insurance.

Genomic biomarker testing:

  • Helomics provides two standard kit options for Genomic Testing samples:
    • Tumor Profiling Kit -Tissue specimens must be shipped in 10% neutral buffered formalin.
    • FFPE Kit – Specimens must be shipped as slides or tissue blocks.
  • Pathology report or confirmed diagnosis from the ordering physician received for the submitted sample.
  • Acceptable signature and date on the order form.
  • Complete patient demographics and insurance.

Specimen rejection criteria:

For all Helomics products, if any of the following criteria are met, then a specimen will be rejected and a Termination Report will be issued to the ordering physician.

  • If a specimen is not properly labeled.
  • If a specimen arrives in an unacceptable medium.
  • If the pathology criterion (origin, histology, stage) is not met or is inappropriate for the requested test.
  • If a physician’s order is not completed and signed.
  • If a patient’s demographics and insurance information is not received.

Clients will be contacted as soon as possible for resolution if issues are identified.

Turnaround times by product:

  • Tumor Drug Response Profiling: 28–35 days after receipt of the fresh tissue and all required paperwork; depending on the growth profile of
    the sample.
  • Genomic Testing: 10–14 days after receipt of the order form and sample; Sample may arrive prior to the order form, but testing will not begin until the order form is received.

Frequently asked questions:

What is tumor drug response testing?

Drug Response profiling is a treatment selection marker. It determines how an individual gynecologic cancer patient is likely to respond to the various types of chemotherapy by testing the treatment options on that patients live cancer cells and measuring cell response. This provides valuable insights that help guide physicians’ treatment decisions, giving you an edge against gynecologic cancer.

Why tumor drug response testing?

Your physician is using every advantage available to improve the odds in your fight against cancer. Drug Response Profiling is designed to reduce your risk of receiving therapies that are ineffective or to identify alternatives when the typical treatments recommended for your type of cancer cannot be tolerated.

What is genomic testing?

Genomic testing is a group of clinically relevant cancer-related biomarker tests that look to your genetics to predict your cancer’s response to various types of chemotherapy and/or the course your disease is likely to take. The biomarkers included in Genomic testing are well-validated and supported by current research and key opinion leaders.

Lawrence J. DeLucas, PhD

VP, OPERATIONS,
Predictive Oncology
Site Leader, Soluble Biotech
At Predictive Oncology

Dr. DeLucas is the Vice president of Operations for Predictive Oncology and President and co-founder of Soluble Biotech, Inc. DeLucas is currently working to complete development of GMP facilities at Soluble Biotech and at TumorGenesis. In addition, he oversees Soluble Biotech’s solubility and stability contracts for numerous pharmaceutical/biotech companies.

Before Predictive Oncology

From 1981-2016 Dr. DeLucas was a faculty member at the University of Alabama at Birmingham (UAB) where he served as a Professor in the School of Optometry, Senior Scientist and Director of the Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology. Dr. DeLucas received five degrees from UAB culminating in a Doctor of Optometry degree and a Ph.D. degree in Biochemistry. He also received honorary Doctor of Science degrees from The Ohio State University, Ferris State University, the State University of New York (SUNY), and the Illinois College of Optometry. He has published 164 peer-reviewed research articles in various scientific journals, co-authored and edited several books on protein crystal growth and membrane proteins and is a co-inventor on 43 patents involving protein crystal growth, novel biotechnologies and structure-based drug design. DeLucas was a payload specialist NASA astronaut and member of the 7-person crew of Space Shuttle Columbia for Mission “STS-50”, called the United States Microgravity Laboratory-1 (USML-1) Spacelab mission. Columbia launched on June 25, 1992, returning on July 9.  In 1994 and 1995, Dr. DeLucas served as the Chief Scientist for the International Space Station at NASA Headquarters in Washington, D.C. In 1999, Dr. DeLucas was recognized as one of the scientists who could shape the 21st century in an article published by “The Sunday Times” of London titled “The Brains Behind the 21st Century”.  In 2004, he was recognized as a Top Ten Finalist for the Entrepreneur of the Year award from the Birmingham Business Journal. 

“ Soluble Biotech is continually demonstrating to pharmaceutical and biotech companies the significant value of its novel HSC technology for optimizing protein therapeutic formulations to treat a variety of chronic and infectious diseases. ”

Education
  • Five degrees from Univ. of Alabama at Birmingham (UAB): B.S. Chemistry, M.S. Chemistry, B.S. Physiological Optics, O.D. Optometry, PhD Biochemistry

  • Published 164 peer-reviewed research articles in various scientific journals

  • 1993-2016: Director of the UAB Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology.

  • NASA Astronaut, flew on Columbia Space

  • 994-1995: Appointed Chief Scientist for the International Space Station at NASA HQ
  • Testing Information

    CHIEF EXECUTIVE OFFICER
    Predictive Oncology
    At Predictive Oncology
    This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO.
    Before Predictive Oncology
    This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO. This paragraph will outline the executive’s role at PO.

    “ Eliminating cancer is our overall goal.  This is not an easy task.  We are working hard every day to make this happen, using our novel technology and talented team of employees. ”

     

     

    Education

    University of Southern California
    School of Business
    MBA, Finance

    University of Colorado Boulder
    BS, Accounting

    Richard Gabriel, BS, MBA

    SVP, RESEARCH & DEVELOPMENT
    Predictive Oncology
    Site Leader, TumorGenesis
    At Predictive Oncology
    My role at Predictive Oncology is to bring the business sense to managing Research and Development programs at all our companies. To seek new ways and opportunities to commercialize exciting new technologies that we have built, licensed, acquired, or are developing through our own research and development. The success of any company is to get the research off the bench and to the customers. That is what I do at POAI and help the other companies as well.
    Before Predictive Oncology
    Prior to starting his first company in 1984 and registering with the FDA a pilot plant facility to make pharmaceutical actives, Mr. Gabriel managed a $50 million product line for W.R. Grace, developed new marketing and sales strategies for Ventron a Division of Morton Thiokol, research work at Ashland Chemical for pressure sensitive adhesives and plant scale-up. Since then, he ran a genetics company, built three GMP/Research facilities, and helped 5 drugs reach their markets in AIDS and cancer. Real expertise in cGMP process scale-up and compliance. Completely understand the needs of an API manufacturing facility and build processes that are scalable, environmentally acceptable, and safe. 3 FDA inspections with no 483’s, ISO certification, DEA registration, DoD compliance, NCI contractor and inventor. Has also broad-based experience in start-up companies and how to make them operational and profitable. 7 years of Team set-up, R&D management, and implementation for 165-person (85 PhD’s and Engineers) company (Pharm-Eco) and lecturer on cGMP and Teams within the Pharmaceutical Industry.
    “ Patients are always first, is our driving force. Oncology is a tough space, and we are determined to bring the best validated science to help cancer patients and as our CEO says; “Eliminate Cancer”. You first must know your enemy before you can defeat them. That takes teamwork and a lot of smart hard-working people, our team members at POAI are up to the challenge. ”

     

     

    Education
    Suffolk University
    Executive MBA Program

    Ohio Dominican College
    BS, Chemistry

    Ohio State University
    Microbiology and Virology

    University of Cincinnati
    Associates Degree, Liberal Arts

    Mark A Collins, Ph.D

    SCIENTIFIC/CUSTOMER DEVELOPMENT
    Predictive Oncology
    Chief Technical Officer, Helomics
    At Predictive Oncology

    Mark is currently Chief Technical Officer at Predictive Oncology. Using the power of AI, Mark is responsible for leveraging Helomics’ vast repository of physical and digital tumor samples, to build multi-omic predictive models of tumor drug response and outcome. Such models can be applied to the discovery of new targeted therapies for cancer as well as used in clinical decision support to help oncologists individualize  treatment.

    Before Predictive Oncology

    Dr. Mark Collins embarked on a career in the pharmaceutical industry following his postdoctoral work. Pursuing a passion for both biology and computing, Mark has held multiple executive roles in a variety of discovery, informatics and bioinformatics functions within global pharma, and founded three startup software companies in the artificial intelligence (AI) machine learning (ML) and drug discovery space. Mark relocated to the USA in 2001 to work for Cellomics (now part of Thermo Fisher Scientific), where he played a pivotal role in establishing the High-Content cell analysis market, building, and commercializing several key informatics and bioinformatics products.

    Since leaving Thermo Fisher, Mark has focused on developing and commercializing informatics solutions for clinical and translational research, specifically in the specimen tracking, ‘omics data management and NGS analysis space, through key roles at BioFortis, Global Specimen Solutions and Genedata

    “ I have been pursuing a vision since the late 1990s that AI will help deliver better patient therapies. I firmly believe at POAI we will deliver on that vision. ”

    Education
    University of Surrey, UK
    Ph.D., Microbiology

    University of Wolverhampton, UK
    Undergraduate Degree, Applied Science

    Bob Myers

    CHIEF FINANCIAL OFFICER
    Predictive Oncology
    Site Leader, Skyline Medical
    At Predictive Oncology

    Executive officer, Compliance Officer, Corporate Secretary, and member of the Senior Leadership Team. Responsible for Finance, Administration, Human Resources, Investor Relations, and IT. Skyline Medical Site Leader.

    Before Predictive Oncology

    Numerous years as CEO/Controller consultant including medical devices companies. Executive positions with CES Computer Solutions, Computer Accomplishments, Hi-Tech Stationary & Printing, Capital Distributors Corp, International Creative Management American Express, Showtime Entertainment and public accounting with Laventhol & Horwath, CPA’s.

    “ It’s a privilege to work with a highly talented team to pursue oncology advances, while protecting and increasing shareholder value. ”

    Education

    Adelphi University
    MBA, Finance

    Hofstra University
    BBA, Public Accounting 

    J. Melville (“Mel”) Engle

    CHIEF EXECUTIVE OFFICER
    & CHAIRMAN OF THE BOARD
    Predictive Oncology
    At Predictive Oncology
    Mr. Engle became POAI’s CEO in 2021 and was appointed to the POAI Board of Directors in 2016. He was elected Chairman of the Board in 2020.
    Before Predictive Oncology
    Between 2012 and 2021, he was CEO of Engle Strategic Solutions, a consulting and coaching company focused on CEO issues. From 2009 to 2012, he was CEO and Chairman of Thermogenesis, a cell separation company. From 2002 to 2007, he was Regional Head/Director, North America at Merck Generics and CEO of Dey Laboratories, a respiratory company From 1996 to 2001, he was CEO and Chairman of Anika Therapeutics, an orthobiologics company From 1980 to 1995, he was with Allergan, Inc., an eye and skin care company, where he served as CFO, Managing Director (living in Toronto), and other positions with the firm

    “ Eliminating cancer is our overall goal.  This is not an easy task.  We are working hard every day to make this happen, using our novel technology and talented team of employees. ”

    Education

    University of Southern California
    School of Business
    MBA, Finance

    University of Colorado Boulder
    BS, Accounting