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SACGHS, Genomic Health, Epigenomics, DeCode Genetics, Stanford University School of Medicine, Pathwork Diagnostics, Genome Canada, University of Victoria-BC, University of British Columbia, Biodiversity Institute of Ontario

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SACGHS Raises Privacy Concerns With DTC Genetic-Testing Services

A passage in a federal government report on genetic testing oversight raises the concern of whether disease-specific mailing lists, which contain medical information of those who have used direct-to-consumer genetic testing services, could violate consumers' privacy.

“While attention has focused primarily on the utility of DTC tests, significant privacy concerns may also arise,” according to the final version of the HHS Secretary's Advisory Committee on Genetics, Health, and Society, released last week. “Currently, many disease-specific patient mailing lists are available through list sellers and represent a strong profit center for these businesses.”

According to the advisory committee, although a keyword search on “genetic” at List Brokers, Inc., a typical list seller, did not produce a consumer list, “concerns exist that this information may become available in the near future.”

Although the Federal Health Insurance Portability and Accountability Act restricts the healthcare system from selling or releasing patient lists and medical information about individuals “given the current lack of regulation of DTC advertising and testing, it is likely that these may become sources of genetic information for marketing or other purposes,” the committee cautioned.

“Even if genetic test results are kept strictly confidential, it is possible that the results could be inferred by analyzing an individual’s Internet usage,” the committee added.

However, according to Genetic Alliance President Sharon Terry, this may be a bit of “fear mongering” on the part of the committee, since it is unlikely that genetic information would be available through purchasable patient lists.

“Everything is possible,” Terry acknowledged to Pharmacogenomics Reporter this week, but added that she is unaware that disease-specific patient mailing lists are widely available for sale and that she would like to see evidence of that.”

Furthermore, if such lists were to exist at some point, and an employer or an insurer got a hold of such a list, she said that under GINA people would be protected from discrimination in such circumstances.

“First, if these lists exist, I am guessing they contain names and addresses, not genetic testing results,” Terry said in an e-mail. “Further, if they do detail results (I can’t imagine that), then for an insurer or employer to rely on them is ludicrous.”

GINA “would absolutely protect someone who had been discriminated against based on information purchased,” she added. “I would be surprised if an insurer or employer would risk their credibility by depending on a purchased list.”

 

 
Sales for Genomic Health's Oncotype Dx Jump 78 Percent in Q1
 
Genomic Health said this week that sales for its Oncotype Dx breast cancer assay rose 78 percent for the first quarter ended March 31, and the firm shaved 4.3 percent off of its net loss year over year.
 
Genomic Health reported total revenues of $23.4 million, up 65.2 percent from revenues of $14.1 million in the first quarter of 2007. Sales of Oncotype Dx were $23.3 million versus $13.1 million in Q1 2007.
 
The Redwood City, Calif.-based firm posted a net loss of $6.6 million, or $.24 per share, compared with a net loss of $6.9 million, or $.28 per share, a year earlier.
 
Its R&D spending increased 23.1 percent to $6.4 million from $5.2 million, while its SG&A costs rose 50 percent to $18.3 million from $12.2 million year over year.
 
Genomic Health finished the quarter with $14.4 million in cash and cash equivalents.
 

 
Epigenomics' Q1 Revenues Increase 12 Percent as It Cuts Net Loss
 
Epigenomics said this week that its revenues increased 12 percent and its net loss decreased by the same amount for the first quarter ended March 31.
 
The Berlin-based molecular diagnostics firm reported revenues of €916,000 ($1.4 million), compared to revenues of €820,000 in the first quarter of 2007. Epigenomics said licensing deals brought in €620,000 of the revenue, while its diagnostics business contributed €106,000 and its biomarker solutions business brought in €190,000.
 
The firm’s net loss for the first quarter was €2.9 million versus a net loss of €3.3 million a year earlier.
 
Its R&D costs dipped slightly to €2.4 million from €2.5 million year over year. It said that its marketing and business development costs decreased 52.5 percent to €225,000, and its general and administrative expenses dropped 16 percent to €917,000 from €1.1 million.
 
Epigenomics finished the quarter with liquid assets of €21.2 million.
 

 
DeCode's Q1 Revenues, Net Loss Rise
 
DeCode Genetics last week reported a 74.4 percent increase in first quarter revenues and an 18.1 percent rise in its net loss.
 
The Reykjavik, Iceland-based firm generated first-quarter revenues of $15 million, compared to revenues of $8.6 million in the first quarter of 2007. The company said the revenue growth was due primarily to continued growth in its genomic services business.
 
"Since the beginning of the year we have sharpened our strategic focus on capturing the commercial potential of our growing portfolio of DNA-based diagnostics for assessing risk of common diseases, and of our personal genome analysis service DecodeMe,” DeCode President and CEO Kari Stefansson said in a statement.
 
DeCode’s R&D spending was flat year over year at $12.7 million, while its SG&A expenses grew 30.9 percent to $7.2 million from $5.5 million.
 
The firm’s net loss was $26.7 million, or $.44 per share, compared to $22.6 million, or $.37 per share, in last year’s first quarter.
 
DeCode finished the quarter with $69.5 million in cash, cash equivalents and investments, including restricted cash equivalents.
 

 
Stanford to Study Pathwork Dx's Unknown Tissue Cancer Test
 
The Stanford University School of Medicine has started a study evaluating a Pathwork Diagnostics tissue-of-origin diagnostic test for tumors that are hard to identify, the company said this week.
 
The company said the new test uses genomics technology to help doctors determine the origin of a tumor and help them plan treatments. Stanford physicians will evaluate the test for its impact on diagnosis for cancer patients with tumors that have been hard to identify, and they will process the samples at the medical school.
 
"Our test is available as a service through our CLIA-certified laboratory so that physicians outside of Stanford University can have specimens processed and clinical results provided,” said Deborah Neff, president and CEO of Pathwork Diagnostics. Neff added that the company is “actively working to obtain FDA clearance so that we can offer a diagnostics kit directly to clinical laboratories at major medical centers.”
 
Stanford also was involved in a four-lab comparison study that used the Pathwork Tissue of Origin Test to perform diagnosis of 60 metastatic and poorly differentiated and undifferentiated tissue samples, the company said.
 
The test measures the expression of over 1,500 genes to compare a tumor’s gene expression profile to 15 known tissues, and provides a probability-based score for each potential tissue, helping doctors to rule out some tissue types.
 
The test uses the company’s Pathchip microarray and runs on the Affymetrix GeneChip System.
 

 
Genome Canada Awards $9.24M for Genomics, Proteomics Research
 
Non-profit group Genome Canada announced this week that it will provide CDN$9.37 million (US$9.24 million) to 13 winning projects in the Genome Canada Technology Development Competition.
 
The competition received 51 proposals for genomics and proteomics projects from across Canada. Genome Canada, which receives funding from the Canadian government and international partners, said the winners received an additional CDN$9.63 million in co-funding from Canadian and international partners.
 
Among the winners are a study of mass spectrometry-based proteomics for drug development and design being conducted by Christoph Borchers at the University of Victoria in British Columbia; a study of single cell genomics led by Carl Hansen and Marco Marra at the University of British Columbia; and a study of environmental barcoding using massively parallel sequencing led by Paul Hebert at the Biodiversity Institute of Ontario. A full list of the grant winners can be found here.
 
The projects will begin this spring and run for two years, Genome Canada said.

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