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

Hosted by Robert Michel

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

Hosted by Robert Michel
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New Semiconductor Technology Accelerates Whole Genome Sequencing at Reduced Cost

Clinical and anatomic pathology laboratories may soon find next-generation DNA sequencing reliable and affordable

Swift advances in whole human genome sequencing may bring clinical applications to pathology on a much faster timeline than expected.

One impressive example of the fast pace of technology improvements is the Ion Torrent, which is a semiconductor-based DNA sequencer now capable of sequencing 100 million base pairs. That is ten times the sequencer’s capacity when it was launched just last December!

It was August of last year when Life Technologies (NASDAQ: LIFE) in Carlsbad, California, paid $375 million to acquire Ion Torrent Systems, a start-up with operations in Guilford, Connecticut, and South San Francisco. If Ion Torrent achieves certain technical milestones through 2012, it will earn another $350 million.

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Is Whole-genome Sequencing Reaching a Tipping Point for Clinical Pathology Laboratories?

High-Density Sequencing Chips Will Soon Be Able To Sequence Five Million SNPs

Rapid gene sequencing is catching the interest of progressive anatomic pathologists. These medical laboratory professionals are interested in using rapid gene sequencing technology to allow them to study tens and hundreds of genes on a patient specimen.

The technologies used in rapid gene sequencing are being developed and improved by a handful of biotech companies who are racing each other be first to deliver systems to the marketplace that can sequence whole human genomes at a cost of $1,000 or less. Some innovative medical laboratories are beginning to acquire these sequencing systems and explore how they might be used for clinical pathology laboratory testing. (more…)

Many Genetic Tests Offered to Consumers Over the Internet are Misleading and of No Practical Use

GAO Gives Congress a Poor Report on Direct-to-Consumer Genetic Tests Sold by Web-Based Companies

According to the Wall Street Journal, Direct-to-consumer (DTC) genetic tests from the four companies 23andMe, Navigenics, deCODE genetics, and Pathway Genomics Corp, are generating results “that are misleading and of little or no practical use.”  This was the finding of the U.S. General Accounting Office (GAO) in its recently released report.

Pathologists and clinical laboratory managers will be interested to know that the GAO sent multiple specimens to these four companies—each of which is organized to sell genetic tests and molecular diagnostics directly to consumers via the Internet. The GAO determined that, even when given identical DNA samples, the tests from these four companies yielded contradictory results.
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Illumina Intends to Migrate Array Technology to Clinical Laboratories

Firm will submit cytogenetic testing system to FDA using pre-IDE process

High-throughput microarray technology used in cytogenetics research may soon have an FDA-cleared product for use by clinical pathology laboratories.

Array-based comparative genomic hybridization can perform the equivalent of hundreds or even thousands of fluorescence in situ hybridization (FISH)  experiments in one array. This technology has become the preferred method for molecular cytogenetics research. Recent advances in the technology are making the system appropriate for use by clinical labs and at least one manufacturer is taking steps to enter this market. (more…)

Palomar Pomerado Health Partners with 23andMe for Genetic Testing

Nation’s largest public health district wants to promote personalized medicine

Here’s an unusual development in genetic testing that shows clinical laboratory managers how fast the lab testing marketplace is changing. Two-hospital Palomar Pomerado Health (PPH), California’s largest public health district, recently partnered with 23andMe to introduce a personalized medicine service in North San Diego County.

PPH now sells 23andMe genetic test kits for $399 at express care centers in two grocery stores and an outpatient center. The test kit, Time magazine’s 2008 pick for Invention of the Year, comes with a 30-minute education session by a nurse practitioner.

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