Diagnostic tests play an important role in the advancement of patient care, from detection of new emerging infectious diseases and identification of effective antibiotics to the advanced molecular diagnostics that are accelerating the development and application of personalized medicine. These tests represent one of the most effective areas of healthcare, efficiently providing a wealth of information that is used by doctors and patients to make critical decisions at every stage of care.

Currently, a diagnostic test produced by a manufacturer and sold to a laboratory must first obtain pre-market clearance or approval from the FDA to support the safety and effectiveness of the test. These tests are also subject to comprehensive quality system requirements from design through distribution, as well as post-market oversight that includes mandatory adverse event reporting and FDA’s recall authority.

Labs that develop, manufacture and use their own similar tests (laboratory developed tests or LDTs), however, do not obtain pre-market approval and are not subject to a post-market surveillance system. Despite this lack of oversight, these LDTs are widely used as interchangeable with FDA-approved or cleared diagnostics. Often patients or even doctors are unaware of the regulatory status of the test being used to make critical treatment decisions.

In November 2015, the Food and Drug Administration (FDA) released a report: The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studiesthat outlines the harm that not regulating laboratory developed tests (LDTs) can cause to patients and to the economy. Included in the report were two case studies about LDTs that screen for ovarian cancer in asymptomatic patients and one LDT that claims it predicts the likelihood that a patient will develop ovarian cancer.

Due to the incredible importance of diagnostic accuracy and patient safety, it is absolutely essential to the patient community that LDTs are properly regulated. It is crucial that these tests are providing accurate and reliable results so that doctors and patients can make the best possible decision about treatments. The items below are the steps that Ovarian Cancer Research Fund Alliance has taken since 2014 to urge the regulation of LDTs for patient safety.

Our history in the regulation of LDTs is below.

June 19, 2015: OCNA Comment Letter to House of Representatives, Committee on Energy and Commerce Chairman in response to the Diagnostic Test Working Group proposal for regulation of all in vitro diagnostics (IVDs) and laboratory developed tests (LDTs)

March 19, 2015: OCNA Comments on FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests (FDA-2014-N-2214-0001)

January 28, 2015: OCNA Comments on Framework for Regulatory Oversight of Laboratory Developed Tests (Docket No. FDA-2011-D-0360)

January 8, 2o15: OCNA Remarks at the FDA LDT General Session

December 10, 2014:  Joint Patient and Provider group LDT Comment Letter to the FDA

July 31, 2014: Patient Advocates Praise Progress on Guidelines for Laboratory Developed Tests