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

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

Hosted by Robert Michel
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It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs

After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.

If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development.

High Stakes Game for All Medical Laboratories Performing LDTs

It is a high-stakes game for everyone involved in medical laboratory testing. Taken literally, many long-established clinical laboratory assays are LDTs. That is true of the conventional Pap smear, as one example. The FDA described the magnitude of the challenge ahead of it when it estimated that there are 11,000 LDTs currently offered by 2,000 medical laboratories.

Thus, pathologists, medical laboratory directors, and lab executives have genuine concerns about what the specifics will be in the final rules. At the same time, thein vitro diagnostic (IVD) industry has its own stake in FDA regulation of LDTs. That’s because IVD manufacturers submit their lab analyzers and test kits to the FDA for review and clearance. Naturally, these companies wonder if FDA regulation of LDTs will create a new class of tough lab test competitors.

At the same time, IVD manufacturers have legitimate concerns about whether FDA resources may be sucked away from review of IVD devices and test kits because the agency finds itself overwhelmed by applications from labs wanting their LDTs to be reviewed and cleared under the final rules.

Clinical Labs with Proprietary LDTS

For clinical laboratory companies that have patent-protected or proprietary LDTs the stakes are equally high. Executives from some of these companies with tests currently in the marketplace have told Dark Daily that they anticipate a flood of LDT applications will hit the FDA, once the final rules are published and become effective. In such a situation, these executives fear that their existing LDTs may not get a speedy review and clearance because of backlogs at the federal agency. Such delays have the potential to cause financial disruption to their companies.

If those are some “bad news” aspects of the FDA’s proposed LDT regulation, there are “good news” elements. Attorney Jane Pine Wood of McDonald Hopkins, a law firm in Cleveland, Ohio, has pointed out that, when the FDA delivered its notice to Congress on July 31, it also gave lawmakers a draft of its proposed guidance on the regulation of LTDs. A careful reading of this document will provide clinical laboratory professionals with the general outlines of the FDA’s current thinking on its scheme to regulate LDTs.

FDA Describes Three Classes of LDTs for Regulation

On this point, the FDA is proposing to create three classes of LTDs. In its documentation provided to Congress, the FDA divided LTDs three classes. Every lab manager will want to know which of the medical laboratory tests that they currently offer may be categorized by the FDA as falling into one of these classes:

  1. Low-risk LDTs (Class I devices).
  2. LDTs for rare diseases and “Traditional LDTs.”  These types of LDTs reflect the types of LDTs that existed when the enforcement discretion policy was initially implemented.
  3. “LDTs for Unmet Needs,” when no FDA-approved or cleared equivalent device is available.

Another insight came from Kuo Tong, CEO of Quorum Consulting of San Francisco, California. He noted that the draft guidelines for LDT regulation incorporate elements from the FDA’s regulation of medical devices (including IVD devices). Thus, pathologists and lab directors may find it useful to learn more about existing medical device regulations as one way to get a better idea of what will be required to obtain FDA clearance of LDTs under the final regulations once they take effect.


Pictured above is Kuo Bianchini Tong, Founder and CEO of Quorum Consulting. He is an expert in the product life cycle for molecular diagnostics, genetic tests, and other advanced healthcare technologies. He is a featured speaker at Dark Daily’s upcoming webinar on the FDA’s proposed guidelines to regulate laboratory-developed tests (LDTs). Tong is shown speaking at last May’s Executive War College on Laboratory and Pathology Management that took place in New Orleans, Louisiana. (Photo copyright The Dark Report.)

Of course, it is a fact that the FDA has yet to take the next step. Given the 60-day notice to Congress on July 31, it is not until the end of this month—at the soonest—that the federal agency could move forward to publish a draft of its guidance for FDA regulation. That would initiate a period for public comment. Following that, the FDA would incorporate public comment into its revised guidelines. Those must be then published, along with a date when the agency would make the final LDT regulations effective.

Experts to Speak about FDA’s Draft Guidance to Regulate LDTs

With the FDA proposing to regulate a large number of LTDs performed daily in a substantial number of the nation’s clinical labs, molecular diagnostics companies, and gene testing labs, Dark Daily has assembled a team of experts to help you stay ahead of these important events. On Wednesday, September 17, 2014 at 1 P.M. EDT, Dark Daily will present the webinar “FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now.”

Providing insights and context about the regulatory, compliance, and procedural issues expected within the FDA’s draft guidelines for LDT regulation will be Attorney Jane Pine Wood of McDonald Hopkins and her colleague and attorney Richard S. Cooper of McDonald Hopkins.  Joining them is Kuo Bianchini Tong, Founder and CEO of Quorum Consulting. His firm provides a wide range of consulting services to labs, biotech companies, and private equity investors on the entire lab-test product lifecycle, including working with public and private payers to establish favorable coverage guidelines and reimbursement for clinical lab tests, including LDTs.

This is a must-attend webinar event for all clinical laboratory professionals responsible for LTDs within their own organizations. It is equally important for the investors, and analysts, financial experts, and consultants working with companies preparing to launch LDTs. The three experts believe that the FDA’s draft guidance is a useful roadmap for understanding what the federal agency wants to achieve, particularly when viewed in the context of how the FDA has regulated medical devices in recent years, including IVD instruments and test kits.

Some Labs with LDTs Will Get a Head Start Over Competing Labs

You are invited to participate in this special webinar and you can register at this link. (Or, copy this URL and paste into your web browser:

Because the FDA’s proposal to regulate LDTs will ensnare such a large proportion of the nation’s clinical laboratories, pathology groups, and specialty molecular/genetic testing organizations, it is possible that the federal agency will be hit with a large volume of LDT applications after the final regulations take effect. That alone is a reason why smart lab executives and pathologists will want to participate on this important webinar. It will help them decide how best to protect the clinical interest of their lab organization, while getting a jump on their toughest competitors.

Related Information:

Webinar: FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now

FDA News Release: FDA takes steps to help ensure the reliability of certain diagnostic tests

FDA Notification to Congress on July 31, 2014 (PDF)

F.D.A. Acts on Lab Tests Developed In-House

FDA Seeks to Regulate Lab-Developed Tests: Agency Says Certain Medical Tests Can Be Prone to Errors