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CMS Rejects Petition to Add Genetic Specialty to CLIA


Nearly one year after three nonprofits petitioned the Centers for Medicare and Medicaid Services to create a genetic specialty under the Clinical Laboratory Improvement Amendments, the agency has concluded that existing quality control guidelines can sufficiently ensure the safety of genetic tests and that adding new directives would be too costly.

Last September, Johns Hopkins University’s Genetics & Public Policy Center, Public Citizen, and Genetic Alliance filed a Citizen Petition asking CMS to strengthen its oversight of genetic tests by creating a genetic testing specialty. In its response, delivered 11 months later, CMS says it has “carefully considered” the petition and has “concluded that the arguments and supportive evidence do not justify rulemaking to establish a new genetics specialty under CLIA at this time.”

Creating a genetic testing specialty under CLIA would be a step toward making proficiency testing mandatory for all CLIA-certified laboratories — a requirement that would be too expensive to meet, according to the agency.

CMS, which last year said it would create a specialty area for genetic tests but changed its mind soon after, didn’t offer an estimate for how much it would cost to develop a genetic specialty. Regardless, GPPC slammed the agency for what it considers choosing cost over public safety.

“CMS has abdicated responsibility for ensuring the quality of genetic tests and has erroneously placed cost considerations above the public’s health,” GPPC Director Kathy Hudson said in a statement. “The letter uses the word ‘cost’ repeatedly, but not once does it mention health and safety. That’s astounding for an agency charged with protecting patients by ensuring laboratory quality.”

GPPC is reviewing its options and plans to offer its expertise to the HHS Secretary’s Advisory Committee on Genetics Health and Society and to Congress, two entities that are separately considering methods to ensure the safety of genetic tests, according to the organization’s Law and Policy Director Gail Javitt.

 — Turna Ray

Short Reads

Newly formed company ParagonDx acquired the assets of Gentris Diagnostics, a subsidiary of Gentris, and will focus on developing molecular diagnostic products for laboratories. ParagonDx also said that Joe Sorge, founder and former CEO of Stratagene, has assumed a controlling stake in the company.

The US Food and Drug Administration should amend the label of irinotecan, a commonly prescribed cancer drug, to reflect that a molecular diagnostic used to predict adverse events in some patients is not required for all patients, according to results of a study from the University of North Carolina at Chapel Hill. Irinotecan, also known as Camptosar, is mainly used as a second-line treatment for colorectal cancer.

Gene Logic announced two separate deals in which it will work with both Solvay Pharmaceuticals and Merck Serono. In both deals, Gene Logic will help identify alternative development paths for multiple drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety.

Royal Philips Electronics and the Institute of Health Sciences in China intend to create a joint research laboratory in Shanghai to study molecular medicine, especially pharmacogenomics. The goal is to perform biomarker discovery and development of in vitro diagnostic tests. Philips intends to locate a team of its own scientists at the joint research laboratory.


US Patent 7,266,483. System and methods for optimized drug delivery and progression of diseased and normal cells. Inventors: Zvia Agur, Sarel Fleishmann, Kirill Skomorovski, and Moshe Vardi. Assignee: Optimata. Issued: September 4, 2007.

This patent covers “systems for recommending an optimal treatment protocol for a specific individual” using “parameters specific to the individual; and a selector to select an optimal treatment protocol from said plurality of treatment protocols based on the modified system model.”

US Patent 7,266,457. High throughput functional genomics. Inventor: James Hickman. Assignee: Hesperos. Issued: September 4, 2007.

This innovative technology can be applied to neurotoxicity, and to screening compounds from combinatorial chemistry, gene function analysis, and basic neuroscience applications, according to the patent abstract. “The system of the invention analyzes how the action potential is interrupted by drugs or toxins.”

Data Point

Prolexys Pharmaceuticals announced the start of its first human trials of PRLX 93936, a potential anti-cancer compound. Phase I studies to test safety, efficacy, and pharmocodynamic properties of the compound will take place at a number of institutes, including Arizona’s TGen.

The Scan

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White-Tailed Deer Harbor SARS-CoV-2 Variants No Longer Infecting Humans, Study Finds

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