News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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What Molecular and Genetic Testing Labs Need to Know to Succeed with Commercialization of Their Precision Medicine Products

Webinar was held Wednesday,
March 22, 2017 at 1PM EDT

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One of healthcare’s unheralded stories is good news for molecular and genetic testing laboratories, along with hospital/health system labs that already have instruments capable of performing these tests! Day-by-day, ever more physicians begin to include elements of precision medicine in their clinical practice, thus requiring them to use molecular and genetic tests.

Physician demand for these tests is robust and will continue to increase for a powerful reason: patients want the benefits from a diagnostic test that delivers a more accurate diagnosis while pointing the doctor to the right therapy that will benefit the patient while minimizing side effects.

These are just two reasons why it is imperative that every clinical laboratory and pathology group have a strategy for how it will serve precision medicine. Tests in support of precision medicine will be the fastest-growing sector of laboratory medicine for years to come. That’s why labs need a strategy that addresses these elements:

1) Which type of precision medicine tests will the lab emphasize?

2) Can it run these tests on existing lab analyzers, or will it need to acquire new instruments?

3) Are there existing physician-champions of precision medicine in the lab’s service area who are respected as clinical leaders and willing to share their patient care successes with colleagues?

4) Can the lab profitably collaborate/partner with labs and companies that already have proven assays, robust informatics capabilities, and similar tools needed to provide tests that support precision medicine?

5) Are there payers in the lab’s regional market that have existing coverage guidelines for the types of precision medicine tests the lab wants to provide? Are the targeted types of precision medicine tests covered by existing managed care contracts?

These important questions about strategy will be among the topics to be covered at what may be the most important webinar about precision medicine lab testing that has yet been delivered to the clinical laboratory industry. The webinar is titled, “What Molecular and Genetic Testing Labs Need to Know to Succeed with Commercialization of Their Precision Medicine Products,” and takes place Wednesday, March 22, at 1 PM EDT.

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Your experts will emphasize the two vital success factors for a lab’s precision medicine test program. For the clinical and operational issues involved in selecting, performing, reporting, and business development to generate specimen referrals, the speakers are Don Rule, CEO, and Yoav Sibony, Vice President of Sales & Marketing, at Translational Software in Bellevue, WA. Translational Software currently provides a full range of services to more than 80 client labs and health organizations that includes annotating and analyzing molecular and genetic test data, helping labs define genetic panels relevant to the lab’s clinicians and augmenting existing panels with interpretation, plus other capabilities.

Next, for the important issue of how to get paid for your lab’s molecular and genetic tests, the speaker is Kyle Fetter, Vice President of Advanced Diagnostics at XIFIN, Inc. in San Diego, CA. XIFIN is one the nation’s largest providers of revenue cycle management services to clinical laboratories, pathology groups, and molecular/genetic testing companies.

Fetter brings an informed perspective to the topic of helping your lab get paid because XIFIN handles several hundreds of millions of lab test claims for its client labs each year. It has electronic interfaces with every health insurance plan in the United States and thus knows the coverage guidelines and criteria needed for molecular and genetic test claims to be successfully adjudicated and reimbursed to the submitting molecular and genetic testing lab company.

And there’s more! Hospital and health system labs are in for a positive surprise. During his presentation, Rule will discuss how existing lab instruments can be used to perform precision medicine testing, thus giving hospital labs a way to generate more specimen referrals while becoming an essential clinical partner with physicians in the inpatient, outreach, and outpatient settings.

Indeed, you and your lab team will be gaining information from three experts with deep experience in the still-young clinical market for precision medicine testing. You will hear up-to-the-minute reports about which areas of precision medicine are growing fastest, including cancer testing and pharmacogenomic testing.

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It’s crucial that every clinical lab and pathology group have a strategy for how it will serve precision medicine! You’ll learn:

  • Know the fastest-growth areas in precision medicine testing, including oncology, pharmacogenomics, infectious disease/antibiotic stewardship
  • Identify the physician-champions in your lab’s community who are considered clinical leaders, ready for precision medicine, and who will help show colleagues how such testing benefits their patients and improves their quality/outcomes performance
  • Master ways to use the hospital lab’s existing analyzers for precision medicine testing without the need for additional capital
  • Learn ways to use referral labs to build physician use of precision medicine tests, creating the volume needed to then perform these same tests in-house
  • Acquire knowledge about how to get paid for these tests
  • Understand the most common reasons why payers reject precision medicine test claims, and how to fix those problems
  • Know the four sources of bad quality costs in your lab: prevention, appraisal, internal failure, external; along with the activities associated with each bad quality source
  • Appreciate the need to optimize the processes used to collect necessary data and present that data properly to the different requirements of different payers
  • Anticipate payer audits and learn the importance of having lab documentation on precision tests match the documentation in the patient record at the physician’s office

As an added bonus, at the conclusion of the presentation, there will be a Q&A period during which you’ll be able to submit your own specific questions to our expert panel. This segment of the webinar represents particularly high value for you and your lab team!

You’ll come away from this webinar with powerful insights about specific types of precision medicine tests that have accepted clinical evidence of utility and are thus becoming a standard of care. These are also the tests for which payers will most readily reimburse when utilized appropriately by physicians.


Don Rule, MBA, Founder and Chief Executive Officer, Translational Software, Bellevue, WA.

Rule is a software professional who founded Translational Software to accelerate the process of bringing molecular diagnostics from the bench to the bedside. Prior to this, he had a 14-year career at Microsoft, holding a variety of program management positions, including roles in providing Internet access to MSN, pioneering virtual private networking products, and integrating instant messaging with voice over IP networks. Rule became fascinated with bioinformatics in 2004 and founded the BioIT Alliance from within Microsoft.

Kyle Fetter, MBA, Vice President of Advanced Diagnostics, XIFIN, Inc., San Diego, CA.

Fetter has implemented and overseen the commercialization and reimbursement processes for over 60 unique complex diagnostic companies releasing new, high-complexity laboratory testing services to the healthcare market. He currently oversees the diagnostic services division of XIFIN, which delivers SaaS-based RPM, LIS, and physician diagnostic applications, in addition to providing consultative and reimbursement services to over 40 complex diagnostic companies at various stages of commercialization and third-party payer contracting. Fetter also oversees the development and commercialization of new, web-based software products at XIFIN, catered to high-complexity testing laboratories. In addition to actively overseeing XIFIN’s large diagnostic services division, Fetter consults with laboratories and biotech companies on developing physician adoption for novel diagnostic products. As such, he projects cash flow for covered and non-covered services, implements successful reimbursement and appeals strategies, and effectively manages the relationship between sales and reimbursement for new medical technology.

Yoav Sibony, MBA, Vice President of Sales and Marketing, Translational Software, Bellevue, WA.

Prior to joining TSI, Sibony served as Vice President of Global Sales for Harvard Bioscience, a global developer of a broad range of tools to advance life science research and regenerative medicine including the Biochrom range of Amino Acid Analyzers screening and monitoring for Inborn Errors of Metabolism. Previous to Harvard Bioscience, Mr. Sibony served as Global Sales Effectiveness Manager at Corning Life Sciences, a division of Corning Inc. In this role, he oversaw global sales operations and strategy development for this approximately $800 million division. Prior to this, he served in progressive positions at the medical technology company Becton, Dickinson & Company; as Regional Business Manager at BD Biosciences Discovery Labware, he oversaw 12 sales territories with combined value of $45 million.