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Monogram Announces First Medicare Payment for Trofile at List Price
 
Monogram Biosciences announced this week that the first Medicare payment for its Trofile Assay has been processed for an amount equaling Monogram's $1,960 list price, by the California-based contractor National Heritage Insurance Company.
 
“For patients throughout the US, Medicare claims for Trofile are submitted to NHIC, which is the local Medicare part B Contractor in California, where Trofile tests are performed,” Monogram said.
 
“NHIC's coding guidance for healthcare providers references the need for tropism testing as indicated in the FDA labeling for maraviroc, and acknowledges that Monogram's Trofile Assay was the test for tropism on which the FDA clinical trials of Selzentry were based.”
 
A difficult reimbursement environment has slowed market adoption of genetic tests in general. The tropism testing market will likely heat up now after the US Food and Drug Administration recently approved Pfizer’s CCR5 co-receptor-blocking anti-retroviral Selzentry. The label for the drug, also called maraviroc, states tropism testing and treatment history should guide treatment with the drug.
 
Pathway Diagnostics announced last week the nationwide availability of SensiTrop, a molecular heteroduplex tracking assay that has been demonstrated to be “highly sensitive in detecting CXCR4-tropic HIV in patient samples that contain as little as 1 percent CXCR4,” the company said in a statement. While Pathway will compete with Monogram, the new player said it is still in the early stages of reimbursement efforts.
 
In contrast, William Young, Monogram CEO, said in a statement that the company is making “good progress in … discussions with other public and private payors with regard to reimbursement for Trofile” and has so far submitted claims to 15 separate payors.
 
“We are encouraged by the initial adoption of Trofile by physicians," Young added.
 

 
Amgen To Use DxS K-RAS Test To Analyze Patient Samples for Pivotal Vectibix Study
 
DxS said this week that Amgen has selected the DxS K-RAS Cancer Mutation Detection Kit to analyze patient samples from its pivotal “408” study examining Vectibix versus best supportive care in patients with metastatic colorectal cancer who have progressed after all available chemotherapy regimens.
 
At a recent European cancer conference, Amgen presented “Analysis of K-RAS mutations in patients with metastatic colorectal cancer receiving panitumumab monotherapy”, which utilized the DxS K-RAS Cancer Mutation Detection Kit. In that study, researchers concluded that the efficacy of panitumumab monotherapy in metastatic colorectal cancer appears to be confined to patients with non-mutated K-RAS.
 
According to DxS, the test – combining Scorpions and allele specific PCR technologies – detects seven key mutations in the K-RAS gene.
 
“The assays can detect less than 1 percent of mutant in a background of wild type genomic DNA and have a limit of detection of 10 copies or below,” the company said.
 
The European Committee for Medicinal Products for Human Use has recommended the European Medicines Agency to issue a conditional marketing authorization for Vectibix in patients with refractory metastatic colorectal cancer whose tumors do not have a mutation of K-RAS. DxS said it is currently in discussion with regulatory authorities and service providers to ensure that an approved diagnostic is available to support the launch of Vectibix.
 

 
In Final Guidance, FDA Restricts Reagent Bundling, Claiming Multiple Functions for Single ASR
 
On Sept. 14, the US Food and Drug Administration issued a guidance document, “Commercially Distributed Analyte Specific Reagents: Frequently Asked Questions.”
 
The final guidance restricts ASR manufacturers from claiming multiple functions for a single ASR and from bundling reagents together in order to sell them as an ASR. Products of this kind that detect multiple genetic variants or simultaneously detect multiple gene expressions should be treated as test kits, and manufactures should subject these kits for premarket review, the agency states in the guidance.
 
The draft form of the guidance was released in September 2006.
 

 
Vanderbilt to Use GenoLogics Software for Colorectal Cancer Research
 
Vanderbilt University will use GenoLogics’ data-management software for research on colorectal cancer, the company said this week.
 
Researchers at Vanderbilt’s Jim Ayers Institute for Precancer Detection and Diagnostics will use the company’s Proteus system in a program aimed at developing a blood test for early detection of colorectal cancers as well as therapies for targeted treatment of specific tumor types, the company said.
 
The researchers are using the software to track samples and store data for clinical trials involving thousands of participants, GenoLogics said.
 
Proteus is enabling the investigators to incorporate clinical data, track non-identifiable patient data, and perform data comparisons involving disease states and tissue proteotypes.
 
Financial terms of the agreement were not released.
 

 
Cepheid Licenses Quantovir's HPV IP to Develop Predictive Dx for Cervical Cancer
 
Cepheid said this week that it plans to use a family of human papillomavirus patents it has exclusively licensed from the Swedish company Quantovir to develop a PCR-based diagnostic test for HPV that will predict a woman’s risk for developing cervical cancer.
 
Cepheid said the test, which will run on the GeneXpert system, will harness Quantovir's technology to create an HPV diagnostic that will measure HPV viral load. This capability, the company said, “may help to identify patients most at risk” of developing cervical cancer and will also make the test “unique among current HPV DNA testing products.”
 
Cepheid CEO John Bishop said in a statement that the company expects the HPV test to "provide accurate PCR results in minutes rather than days in a variety of clinical settings."
 
The estimated market for HPV diagnostic preventative testing may be between $600 million and $700 million, the company said.
 
Quantovir was founded in 2001, when it was spun out from the Genetics and Pathology department at Uppsala University.
 
Financial terms of the agreement were not released.
 

 
GATC to Coordinate International Sepsis-Pathogen Dx Project
 
GATC Biotech said this week that it is coordinating an international effort to develop a microarray-based diagnostics test for bacterial and fungal pathogens that trigger sepsis.
 
GATC, based in Constance, Germany, said that it will function as the coordinating partner for the project, which includes the Fraunhofer Institute in Germany and the National University of Pusan and Gene In, which are both located in South Korea.
 
The German Federal Ministry of Education, Science, Research and Technology will put up some of the funds for the research, the company added.
 
Each year, there are around 18 million cases of sepsis in the world, and between 28 percent and 50 percent of these infections are fatal, according to the company. GATC said the global financial cost of these illnesses total an estimated €7.6 billion ($10.7 billion).
 
The proposed diagnostic would “enable the immediate detection of organism-specific nucleic acid sequences, offering the advantage of reducing the time between sample collection and diagnosis, leading to a reduction in mortality rates,” the company said.
 
A timeline for completion of the diagnostic was not provided.
 

 
Cepheid Loses Influenza Dx Contract with CDC
 
Cepheid last week said its contract with the Centers for Disease Control and Prevention to develop an influenza virus diagnostic has been terminated.
 
The Sunnyvale, Calif.-based diagnostics developer did not explain why the CDC terminated the contract to develop a rapid point-of-care diagnostic to detect influenza viruses A and B and the H5N1 avian flu virus in human respiratory specimens.
 
Cepheid CEO John Bishop said in a statement that the company's financial guidance for 2007 "remains unchanged."
 
CDC awarded a $2.4 million contract to develop the test to Cepheid in December 2006.
 
At the time, the company said it would "develop an automated test for use on the GeneXpert system using real-time PCR, which will not require specific expertise or specialized training."
 
The CDC at the same time issued a small flurry of influenza diagnostic contracts totaling over $12 million, including $4.5 million to Nanogen, $3.8 million to Iquum, and $700,000 to MesoScale.
 
CDC Director Julie Gerberding said at the time of the awards that the center was aiming to discover "promising technology that could help doctors treat their patients faster and help public health authorities track influenza viruses that could spur a pandemic."
 
A company spokesperson said that Cepheid successfully completed the original $2.4 million contract.
 

 
Roche's Third $3B Offer for Ventana Rebuffed as 'Grossly Inadequate'
 
Roche said last week it has extended until Nov. 1 its offer to buy Ventana Medical Systems, which was set to expire at the close of business Sept. 20. Ventana immediately volleyed back that it would again reject the proposal, saying Roche's offer is "grossly inadequate."
 
This deadline is the third that Roche has set for its unsolicited offer to buy Ventana for $75 a share, or around $3 billion, which it first announced in late June. Roche reiterated last week that the offer is a 44 percent premium over Ventana's closing price before the deal was originally announced, and a 55 percent premium over Ventana's three-month average of $48.30 before the initial offer.
 
Ventana reiterated last week, following Roche’s offer, that the company is worth "significantly more than Roche is offering."
 
"We are continuing to build momentum in our core businesses and are increasingly well positioned to capitalize on the significant potential of the emerging field of companion diagnostics and personalized medicine," the company said, adding that its board of directors also has recommended that "stockholders not tender any of their shares to Roche.”
 
Roche pointed out that it now has tendered around 63,500 shares, but Ventana responded by saying that amounts to less than one percent of the company's roughly 34 million outstanding shares.
 
As Pharmacogenomics Reporter sister publication GenomeWeb Daily News reported in August, Roche also challenged a law in Arizona that would prevent it from exercising control over Ventana if it could get a majority stake in the company. Last week, the US District Court for the District of Arizona sided with Roche in ruling that Ventana may not take “any action to invoke, apply, or enforce the provisions” of the Arizona Control Share Act and the Arizona Business Combination Act.
 
Roche also had filed suit in Delaware that would take away Ventana's ability to employ a "poison pill" defense, which would dilute Roche's holdings if it attempts to buy more than 20 percent of the company. That challenge is ongoing.

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The Scan

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