personalized medicine

Invitrogen gets breast cancer test approval

Maureen Martino — Wed, 09 Jul 2008 12:19:31 -0400

Invitrogen has won FDA approval of a test that can determine whether a woman with breast cancer will benefit from Genentech's Herceptin. The SPOT-Light test, as it is known, uses a DNA probe for the HER2 gene, which is amplified in 18 to 30 percent of breast cancers and can predict whether a patient will benefit from Herceptin. While a test is already available for Herceptin, many smaller hospitals don't have the resources to process the tests. Invitrogen's SPOT-Light doesn't require specialized equipment and can be processed in most hospital labs.

"Given the emerging potential use of trastuzumab (Herceptin) in the adjuvant setting, the need to accurately determine the front-line HER2 status in breast cancer has never been more critical," said Jeffrey Ross, M.D., of Albany Medical College. Invitrogen's test is yet another step in the direciton of personalized medicine. Such tests allow physicians to choose the right treatment for patients and save money by not giving the expensive drug to patients who won't benefit from it.

- check out Invitrogen's release
- read the Sign on San Diego article for more

Expert forecasts revolution in drug dev. work

John Carroll — Fri, 20 Jun 2008 07:14:19 -0400

In the not too distant future drug development work will be revolutionized by new computer technology that will "test" experimental therapies on virtual humans, says a new report from PricewaterhouseCoopers. The new computer-based human model will be instantly adapted to represent every disease, says Steve Arlington. And the cost of drug discovery can be cut by as much as two thirds.

That sort of brave new world would engineer a profound change for drug developers, who take years and hundreds of millions of dollars to advance a drug--often finding out in late-stage trials that they don't work as expected. It's also the kind of model that better suits an approaching age of personalized medicine, when a new generation of therapies will be developed that are more narrowly designed to address disease.

"We are not suggesting that drugs be trialed before they are ready but by 2020 we should be living in an environment where technology will allow doctors and patients to do this," says Arlington. Another sensible way to change the approval process, he says, would be to allow regulators to approve a drug for use in small populations and then expand its use as more data becomes available.

- read the article from The Times

Perlegen, 454 to study drug response

Tue, 02 Oct 2007 06:59:56 -0400

Perlegen Sciences and 454 Life Sciences (now owned by Roche) have teamed up to conduct large scale genetic re-sequencing in DNA samples collected from people with specific responses to an undisclosed class of drug. The companies hope to identify a specific genetic variation and create a test to administer to patients taking the drug that will determine what their response will be. "This study holds the promise to improve therapeutic outcomes for a vast number of patients," noted Bryan Walser, MD, CEO of Perlegen. Perlegen was a 2003 Fierce 15 company.

- check out the release on the deal

Related Articles:
Roche snares 454's sequencing tech in buyout. Report
454 makes big advance in sequencing technology. Report
Perlegen strikes collaboration deal with Genentech. Report

Genetic test seen as big step to personalized meds

Tue, 18 Sep 2007 06:59:58 -0400

A few weeks ago, the FDA roiled the scientific community with its decision that patients should be tested to determine if they were genetically inclined to dangerous reactions to the commonly used blood thinner warfarin. Now the FDA has approved the genetic test that can do just that. About one in every three patients taking the drug have genetic variations that expose them to an elevated risk of dangerous bleeding. Nanosphere (which recently launched a $100 million IPO) makes the newly-approved genetic test, but regulators say that patients will still need to receive blood tests.

The advent of the warfarin test has been held out as a concrete example of the dawning age when drugs will be delivered to populations that match a careful genetic profile. That's been one of the themes here at the 13th European Congress on Biotechnology. Dr. Jonathan Knowles, the president of group research at Roche, kicked off the keynote speeches here with a review of the drive toward more personalized medicines. But several speakers here have noted that the trend to develop drugs with higher efficacy rates among smaller populations is likely to fuel drug inflation--an extremely sensitive topic in Europe, where governments have used all their influence to negotiate lower prices for their populations.

- check out this release for more

Related Articles:
Warfarin label change spotlights molecular diagnostics. Report
Warfarin label to include genetic test suggestion. Report
Diagnostics tied to new drugs. Report
Personalized medicine advances with new genetic test. Report

Molecular diagnostics firm gains $34M in VC

Tue, 28 Aug 2007 06:59:55 -0400

Amsterdam-based Agendia, a molecular diagnostics company, has raised $34 million in its fourth venture round, adding ING to its list of backers. Current investors Van Herk Biotech, Gilde Healthcare Partners and Global Life Science Ventures also participated. The company developed the MammaPrint, a prognostic DNA microarray-based in vitro diagnostic test that measures the activity of 70 genes to assess the risk of breast cancer recurrence.

- check out the release on the latest round

Related Article:
Personalized medicine advances with Agendia's new genetic test. Report
Diagnostics tied to new drugs. Report