Clinical pathology laboratories often find it difficult to get accurate information about various molecular and genetic assays


Because of advances in automated molecular systems and less complex technologies, it is now possible for more clinical pathology laboratories in community hospitals to establish their own molecular diagnostics testing program. This is particularly true of testing for infectious disease and cancer.

At the same time that local pathology and clinical laboratories have this opportunity to provide useful new molecular and genetic tests to physicians in their community, questions often remain about how to assess the clinical value of performing a molecular diagnostic test versus the cost of performing that assay. Adequate reimbursement is another equally important part of the decision to offer a new molecular or genetic test.

“Now, more than ever, it is essential for clinical laboratories in hospitals to provide a state-of-the-art menu of molecular tests,” stated Frederick L. Kiechle, M.D., Ph.D., Medical Director, Clinical Pathology, Pathology Consultants of South Broward, LLP. “Rapid molecular assays for a variety of infectious diseases now allow physicians to respond quickly, for example, to screen inpatients at admission and get the fast diagnostic answer that guides immediate and appropriate therapy.”

Kiechle has long experience with offering molecular diagnostics in a hospital setting. In the late 1980s, he was one of the first pathologists to establish an in-house molecular testing program at his hospital. “The questions are familiar to every pathologist,” he observed. “What molecular tests should we bring in-house? How do we determine the clinical benefit to the doctor and patient? Do the payers in my region reimburse adequately for these tests?”

Molecular Diagnostics for Community Hospital LabsKiechle will discuss these questions and offer his recommendations on the essential steps to establishing a successful molecular diagnostics testing program in hospital laboratories. He is one of three experts who will speak at The Dark Report’s upcoming audio conference “Molecular Diagnostics for Community Hospital Labs: Hitting Clinical and Financial Home Runs in Infectious Disease and Oncology Testing.” It takes place on Wednesday, August 25, at 1 P.M. EST.

In particular, during this audio conference, Kiechle will speak to the opportunities for hospital laboratories to set up and offer molecular assays for infectious disease testing.

Two experts on molecular diagnostics in cancer testing—with an emphasis on solid tumors—will join Dr. Kiechle on the audio conference. They are Gregory A. Hosler, M.D., Ph.D., Pathologist; and Kathleen M Murphy, Ph.D., Director of Clinical Laboratory Operations. Both individuals are part of ProPath, the successful regional pathology super-practice based in Dallas, Texas.

Probably no area of pathology and laboratory medicine is undergoing faster change than cancer testing. New molecular assays are flooding into the market. Every month, additional papers on useful biomarkers are published in medical journals. This rapid pace of change confronts every hospital laboratory and pathology group with a challenge: When is the right time to “go molecular” and do local testing in support of physicians and patients in the community? And, will the lab get paid by health insurers for these expensive molecular and genetic tests?

Together, Hosler and Murphy will cover the essentials of evaluating molecular and genetic tests for cancer. ProPath provides pathology services to numerous hospitals in and around Dallas, so they have plenty of real-world experience and wisdom to share during the August 25 audio conference.

This is practical knowledge about what works—and what to avoid when developing an in-house molecular diagnostics program for cancer testing at a community hospital. The first step is to select the right molecular assay that advances patient care. The important second step is to determine if there is adequate payment from health insurers. This is essential if the laboratory is to operate in a financially-sustainable way.

What may be most interesting to many pathologists are two issues in molecular testing which are seldom discussed publicly—yet often prove troublesome to local pathologists in the daily course of business. “In dealing with cancer cases, selecting the best send-out laboratory to do the next round of specialized molecular testing can be a challenge,” noted Kiechle. “Some of these are very tough questions. Does the proprietary molecular test offered by a reference laboratory truly deliver a clinically-useful and accurate answer? Are there published studies which support the claims that referral lab makes about its proprietary assay? Why is the attending physician directing us to send this patient’s tissue to a reference laboratory that may be unknown to the pathologists in our laboratory?”

Kiechle and his two colleagues will discuss the answers to these questions. They will provide guidance on how hospital laboratories and local pathology groups can develop a top-flight panel of referral and reference laboratories for the different types of cancer cases that come into their labs.

In planning for this audio conference on molecular diagnostics, the three experts agreed that another important subject to be discussed involves the changing nature of the pathologists’ long-standing role as the “gatekeeper.” This is the traditional professional relationship with local physicians that allows pathologists to sustain the clinical integrity of lab testing done on behalf of the hospital’s patients, even as physicians respect and value the consultative services delivered to them by the pathologists.

In today’s healthcare marketplace, many national laboratory companies now bypass the hospital’s pathologists and send their sales reps directly to the doctors’ offices to detail them about proprietary molecular tests. This circumvents the long-standing role pathologists have with physicians as a consultative resource on laboratory testing. During the August 25 audio conference, the three experts will offer insights on the most effective ways to respond to these marketplace developments.

You are invited to join in and listen to this valuable session about molecular diagnostics and genetic testing. The audio conference “Molecular Diagnostics for Community Hospital Labs: Hitting Clinical and Financial Home Runs in Infectious Disease and Oncology Testing” will take place on Wednesday, August 25, at 1 P.M. EST.

You’ll have the opportunity to ask your own questions and explore the best steps to establishing a winning molecular diagnostics program in your laboratory. All this for one low flat fee of only $245 per dial-in site. So don’t wait! Reserve your “seat” today for this very special conference.

THE DARK REPORT AUDIO CONFERENCE AT A GLANCE

DATE: Wednesday, August 25, at 1 P.M. EST

TIME: 1 p.m. EDT; 12 p.m. CDT; 11 a.m. MDT; 10 a.m. PDT

PLACE: Your telephone or speakerphone

COST: $245 per dial-in site (unlimited attendance per site)

TO REGISTER: CLICK HERE or call 1-800-560-6363 toll-free

HOW TO REGISTER:

1. Online

2. Call toll free: 800-560-6363

Registrations accepted until noon EST August 25. Cancellations before 5:00 p.m. EST on Monday, August 23, 2010 may receive a full refund less a $25 service charge.

Your audio conference registration includes:

• A site license to attend the conference (invite as many people as you can fit around your speakerphone at no extra charge)

• Downloadable PowerPoint presentations from our speakers

• A full transcript emailed to you soon after the conference

• The opportunity to connect directly with our speakers during the audience Q&A session