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As Implementation Looms, EEOC Holds GINA Meeting

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In line with the statutes of the Genetic Information Nondiscrimination Act, the Equal Employment Opportunity Commission issued a notice of proposed rulemaking to gather public comments on how best to implement the law and protect people from employment discrimination based on genetic information.

GINA, which was finally signed into law by President George W. Bush last year after being held up in Congress for more than a decade, prohibits genetic discrimination from insurers (Title I) and from employers (Title II).

Under Title II of the law, the EEOC must issue regulations by May. As a result, the commission in late February issued an NPRM implementing Title II and held a public hearing at its new headquarters in Washington, DC, to discuss the topic of genetic discrimination in the workplace. The public has 60 days from Feb. 25 to comment on the document.

Title II of GINA makes it unlawful for an employer to make hiring, firing, or compensation decisions based on the genetic information of an employee or their family members. Furthermore, the law generally prohibits employers from requesting, requiring, or purchasing their employees' genetic information.

At the public meeting, speakers from groups representing employers and employees pointed out the need for the EEOC to clarify the definition of "inadvertent acquisition" of genetic information under which employers would not be held in violation of the law, and to provide specific examples of the types of "manifested diseases" for which the law does not shield a person's genetic data from employment discrimination.

Employers would not be violating the law if they "inadvertently" gain access to the family medical history of employees through an employer-sponsored wellness program; via authorization by the employee; through publicly available, commercial information; or as part of a program to monitor biological effects of toxic substances in the workplace, according to GINA.

— Turna Ray


PGx & Molecular Dx Notes

Hewlett Packard and Partners HealthCare extended an agreement to develop software and implement hardware and services supporting Partners' personalized medicine and clinical genomics program. HP will extend Partners' IT infrastructure, with a particular focus on data storage capabilities to handle next-generation sequencing data.

Novartis formed an in-house molecular diagnostics unit to improve the co-development of companion diagnostics and drugs. The group, co-located in Cambridge, Mass., and Basel, Switzerland, was created in January.

CollabRx launched a new personal genomics service designed to provide cancer patients with information about specific treatment options that their physicians might otherwise overlook.


Datapoint

$50 million
Amount raised By Clinical in debt financing to support late-stage therapeutics development


Funded Grants

$155,774/FY 2008
Point of care genotyping assays, and algorithm for warfarin dosing
Grantee: Bertrand Lemieux, BioHelix
Began: Sep. 19, 2008; Ends: Mar. 18, 2009

This funding will go toward the development of "a low-cost, instrument free genotyping system that does not require large quantities of extensively purified DNA, and that includes a web-based computational tool that integrates genetic and physical factors to offer an individualized predictive model for warfarin dose," according to the abstract.

$180,360/FY 2008
Validation Study of Select Biomarkers for the Diagnosis of Pancreatic Cancer
Grantee: Michelle Ann Anderson, University of Michigan
Began: Apr. 15, 2008; Ends: Mar. 31, 2013

Anderson plans to help "determine whether a select panel of biomarkers can detect pancreatic neoplasia at an early stage," the abstract says. She will evaluate maspin, cathepsin E, ATDC, CEACAM-1, S100P, and CEA-6 as part of the study. The markers have proven to be detectable with qPCR and appear to differentiate pancreatic cancer, chronic pancreatitis, and normal tissue.

The Scan

Study Tracks Off-Target Gene Edits Linked to Epigenetic Features

Using machine learning, researchers characterize in BMC Genomics the potential off-target effects of 19 computed or experimentally determined epigenetic features during CRISPR-Cas9 editing.

Coronary Artery Disease Risk Loci, Candidate Genes Identified in GWAS Meta-Analysis

A GWAS in Nature Genetics of nearly 1.4 million coronary artery disease cases and controls focused in on more than 200 candidate causal genes, including the cell motility-related myosin gene MYO9B.

Multiple Sclerosis Contributors Found in Proteome-Wide Association Study

With a combination of genome-wide association and brain proteome data, researchers in the Annals of Clinical and Translational Neurology tracked down dozens of potential multiple sclerosis risk proteins.

Quality Improvement Study Compares Molecular Tumor Boards, Central Consensus Recommendations

With 50 simulated cancer cases, researchers in JAMA Network Open compared molecular tumor board recommendations with central consensus plans at a dozen centers in Japan.