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Amgen UK, Lab21, Metabolon, European Group for the Study of Insulin Resistance, EU-EuroGentest, Perlegen Sciences, GlaxoSmithKline, Third Wave Technologies, FDA, DeCode Genetics

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Amgen, Lab21 Partner to Launch New Bowel Cancer Dx In UK
 
Amgen UK and Lab21 have announced their partnership to introduce a new gene-based companion diagnostic test for advanced bowel cancer treatment in the UK.
 
Under the terms of the agreement, Lab21 will provide a screening test that will gauge, which patients are likely to benefit from Amgen’s bowel cancer drug Vectibix, more commonly known as panitumumab. The diagnostic was developed by DxS, a UK-based company that specializes in biomarker assays and companion diagnostics for targeted cancer therapies.
 
“It is the first time that the European Commission has licensed a bowel cancer product with the stipulation that a predictive test should be carried out,” Amgen said in a statement.
 
Vectibix was approved in the UK earlier this year and is indicated for the treatment of metastatic bowel cancer for patients who have failed standard chemotherapy and have a specific gene mutation. Biomarker analysis of a pivotal clinical trial showed that the drug doubled median progression-free survival in patients with non-mutated wild type Kirsten Rat Sarcoma 2 viral oncogene homologue compared with patients receiving just best supportive care.
 
According to Amgen, scientists discovered that “only those patients with the non-mutated (wild type) KRAS would respond to Vectibix,” the company said in a statement. “Patients with metastatic bowel cancer will be tested for the presence of the wild type KRAS gene before they are prescribed the drug.”
 
Approximately 60 percent of advanced bowel cancer patients have wild type KRAS. Amgen estimates that of these patients, as many as 60 percent would likely respond to Vectibix. Over 36,000 people in Britain are afflicted with bowel cancer every year.
 
“We now know that Vectibix will only be effective in those patients whose cancers are positive for non-mutated (wild type) KRAS,” Charles Brigden, Amgen UK’s medical director, said in a statement. “Conversely, it also means that we can exclude those patients in whom the agent will not be beneficial.”
 

 
Metabolon Collaborates with Euro Sample Banks on Pre-Diabetes Dx
 
Metabolon will collaborate with a group of European research centers to find biomarkers that are related to insulin resistance in an effort to develop a test that could detect diabetes before an individual has the disease.
 
Under the collaboration, Metabolon said it will discover and validate biomarkers from samples collected from studies conducted at 19 different clinical research centers that are members of the European Group for the Study of Insulin Resistance.
 
Insulin resistance generally is an asymptomatic condition that can precede the arrival of type 2 diabetes, and it is estimated to affect around one-third of the adult population in the US, or around 75 million people, the company said. 
 
The company plans to use the research to speed up development of its Quantose test for screening of pre-diabetic patients.
 
Metabolon CEO John Ryals said the “routine test will help identify pre-diabetic patients years before they become diabetic,” and that it could be used to help doctors “intervene with lifestyle or drug therapies which may delay or prevent the onset of type 2 diabetes.”
 
Financial terms of the collaboration were not released.
 

 
EuroGentest Making Genetic Testing Lab Credentials Publicly Available
 
The European Union is making information about genetic testing labs available to individuals who are taking genetic tests, according to the EU-funded EuroGentest project.
 
“As genetic testing increases across the EU, it is essential that patients and their families have utmost confidence in the laboratories performing tests,” said Jean-Jacques Cassiman, who is a professor at the Center for Human Genetics and a coordinator for EuroGentest.
 
The project has collated data on the majority of the more than 1,500 labs involved in member and associated EU states, according to EuroGentest. The group has made that data available and free to access via a new version of Orphanet, a public portal for rare disease information.
 
The search tool lists the tests that labs perform, accreditation status, staff qualifications, and research interests.
 
Giving patients the ability to search a particular lab on Orphanet “gives confidence in the validity of the results of genetic tests, and means that families are able to make better, more informed decisions,” said Alastair Kent, who is director of the Genetic Interest Group.
 

 
Perlegen to Mine 4 Million Patient Records for Predictive Markers
 
Perlegen Sciences said this week it will work with an undisclosed electronic medical records company to search through data from four million patients for genetic markers that could help predict patient response to certain medical treatments.
 
Perlegen said it has reached an agreement under which it will have exclusive access to a database of US medical records, from which it will target patients who will be sought for DNA samples.
 
The EMR company will be paid subscription and program fees and milestone payments connected to the launch of any new diagnostic tests that result from the collaboration. Perlegen also said it will receive partial ownership in the EMR provider, the volume of which will be dependent on achieving certain revenue levels.
 
Perlegen, which is a spinout of Affymetrix, said it will work with the patients’ doctors to obtain the DNA samples in a way that is compliant with US privacy laws. That means that Perlegen “will never have access to specific patient identities, but instead will only receive de-identified patient records, which can then be re-identified only by participating healthcare institutions” in a manner that is consistent with US health insurance law.
 

 
GSK Study: Polymorphisms Don't Affect Response to Advair or Serevent
 
A GlaxoSmithKline study suggests variants in the gene coding for the beta-2 adrenergic receptor do not affect an individual’s response to its asthma drugs Advair Diskus (fluticasone propionate and salmeterol inhalation powder) or Serevent Diskus (salmeterol xinofoate inhalation powder), the company announced this week at the American Academy of Allergy, Asthma and Immunology annual meeting in Philadelphia.
 
The data, presented by Eugene Bleecker, the co-director of Wake Forest University School of Medicine’s Center for Human Genomics, was based on a trial of 544 patients taking Advair or Serevent for 16 weeks. Previous studies indicated that genetic differences in the beta-2 adrenergic receptor affect patient response to beta-agonists such as albuterol.
 
In contrast, the results of this study suggest that individuals with three different forms of the beta-2 adrenergic receptor all respond similarly to Advair and Serevent based on outcomes such as morning expiratory flow rate, improvement on treatment, forced expiratory volume, and symptom-free days. Another study examining 11 beta-2 adrenergic receptor polymorphisms found no single variation that influenced Advair or Serevent response.
 
Other data presented at the meeting by Harold Nelson, a researcher at Denver’s National Jewish Medical and Research Center, suggests that variations in the beta-2 adrenergic receptor gene also do not influence the incidence of exacerbated asthma symptoms or related hospital visits.
 

 
FDA Clears Third Wave's CF Genotyping Test
 
Third Wave Technologies last week said that the US Food and Drug Administration has cleared its InPlex cystic fibrosis genotyping test.
 
The InPlex CF Molecular Test is based on Third Wave's Invader chemistry and a microfluidic card developed in collaboration with 3M.
 
The company said that in studies submitted to the FDA as part of its clearance application, the test achieved 100 percent agreement on cystic-fibrosis positive samples and 99.96 overall agreement when compared to DNA sequencing.
 
Third Wave said the test can be used in carrier screening for adults, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.
 
Kevin Conroy, president and chief executive of Third Wave, said in a statement that around 70 labs are currently using the company’s InPlex analyte specific reagents for CF testing.
 
Conroy said that FDA clearance for the test will enable the company to expand its presence in the cystic fibrosis market. He estimated that Third Wave currently holds around 15 percent of that market.
 

 
DeCode Genetics' Q4 Revenues, Loss Rise
 
DeCode Genetics reported last week a 15.7 percent increase in fourth-quarter revenues and a 39.7 percent spike in its net loss.
 
The Reykjavik, Iceland-based firm brought in revenues of $13.3 million for the three months ended Dec. 31, compared with $11.5 million in the fourth quarter of 2006.
 
DeCode’s net loss for the quarter was $32.4 million, or $.53 per share, compared with a net loss of $23.2 million, or $.38 per share, for the fourth quarter of 2006. The Q4 2007 results include a $7.7 million charge related to impairment of auction rate securities that the firm holds.
 
"Recent uncertainties in the credit markets have prevented us and other investors from liquidating holdings of our remaining ARS in recent auctions because the amount of securities submitted for sale has exceeded the amount of purchase orders," the firm said in a statement.
 
“Obviously, we are not happy with the illiquidity of the auction rate securities," DeCode CEO Kari Stefansson said during a conference call last week. "However, we are taking the appropriate measures in an attempt to recover the money invested in them.”
 
The firm’s R&D costs dropped 11.3 percent to $12.6 million from $14.2 million, while its SG&A costs declined 10.5 percent to $7.7 million from $8.6 million.
 
For full-year 2007, DeCode’s revenues were flat at $40.4 million compared with $40.5 million in 2006. The firm’s net loss climbed to $95.5 million, or $1.57 per share, from $85.5 million, or $1.49 per share.
 
Its 2007 R&D spending dipped to $53.8 million from $57.1 million, and its SG&A expenses climbed slightly to $27.1 million from $25.2 million.
 
DeCode finished 2007 with $94.1 million in cash, cash equivalents, restricted cash equivalents, and current and non-current investments.
 
“A core focus this year will be on our diagnostic business," Stefansson said during the call. “We believe that we have put in place the key pieces to begin to reap the benefits of this work. We are working to speed the pace of commercial ramp up and expect to be in a position to give you guidance for diagnostic revenues in 2008 and perhaps 2009 in mid-year.”

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