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FDA, Exact Sciences, Nanosphere, Roche, RBM

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FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval
 
Exact Sciences said this week that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
 
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.
 
Company President Jeffrey Luber said in a statement that Exact has discussed the letter with the FDA, and that it is "committed to working collaboratively” with the agency to pursue the appropriate filing strategy for the test.
 
Luber said the firm has a meeting scheduled with the FDA in the “coming weeks” and that it plans to file a 510(k) application “as soon as possible to resolve these issues.”
 
He added that "a potential regulatory filing for our patent-protected technology had already been a long-term strategy for Exact and we will now be accelerating these activities."
 
Exact has an existing agreement with Laboratory Corporation of America to distribute the PreGen-Plus colorectal cancer screening test. The companies expanded the deal in June to give LabCorp rights to exclusively license the test through 2010. 
 

 
FDA Clears Nanosphere Assay for Coagulation-Linked Gene Mutations
 
Nanosphere this week said that the US Food and Drug Administration has cleared a test that detects gene mutations linked with blood coagulation and metabolism disorders.
 
Nanosphere’s F5/F2/MTHFR Nucleic Acid Test runs on the company’s Verigene System and can be applied in single or multiplex formats.
 
It tests for mutations in three specific genes that together can increase the risk of blood clots and resulting ischemic stroke.
 
As Pharmacogenomics Reporter last month reported, the FDA has also cleared Nanosphere’s test for gene variants linked to sensitivity to the anticoagulant warfarin.
 

 
Roche Molecular Dx Revenue Slides 3 Percent as Applied Science Surges 10 Percent Over Past Nine Months
 
Roche reported this week that total receipts for its molecular diagnostics segment declined 3 percent in the first three quarters of 2007, compared with the same period one year ago, but overall revenue for the entire Diagnostics business rose 5 percent year over year.
 
Diagnostics sales overall rose to CHF 6.8 billion ($5.7 billion) while Molecular Diagnostics declined to CHF 856 million. However, excluding industrial reagents, sales in Molecular Diagnostics were up 3 percent.
 
Virology, “one of the business area’s largest segments,” rose 3 percent, driven by placements of the automated Cobas AmpliPrep/Cobas TaqMan platform in European, Asia-Pacific, and US markets, Roche said
 
Meantime, Roche Applied Science posted a 10-percent increase in nine-month sales. The segment's main growth drivers were the LightCycler 480 and Genome Sequencer 20 systems and research reagents, according to the company.
 
The company said all regions contributed to diagnostics sales in the first nine months, but pointed out particularly strong growth of 18 percent in the Asia-Pacific regions.
 

 
RBM Nets $25M in VC Cash; Funds Will Help Finance M&A, Grow Dx Service
 
Multiplexed biomarker testing lab Rules-Based Medicine has raised $25 million in a Series A round of private equity financing, the company said this week.
 
The Austin, Tex.-based shop said it plans to use the cash for aggressive growth in the services business, to fund development of diagnostics services and kits, to shore up its balance sheet, to repay debts, and to make acquisitions and investments in the biomarker and medical diagnostics fields.
 
In addition, RBM will use $12.5 million of the financing to pay Luminex under the terms of a lawsuit settlement disclosed earlier this week. The suit has to do with Biophysical Corporation’s testing services, Luminex said.
 
RBM, which was spun off from Luminex in September 2002, initially filed the claims in a Travis County, Texas District Court in 2005, but Luminex soon afterward responded with its own counterclaims.
  
The settlement, which formally dismisses the lawsuit, includes the retirement of Luminex’s ownership of RBM stock and “the grant of certain additional licensing rights,” Luminex said.
 
All other terms of the agreement are confidential, Luminex said.
 

 
Rules-Based Medicine Gets $1.1M SBIR Grant to Develop 50 Cancer Biomarker Assays
 
The National Cancer Institute has given Rules-Based Medicine a $1.1 million Phase I/Phase II Small Business Innovation Research contract to develop immunoassays for cancer, the biomarker testing company said last week.
 
Austin, Texas-based RBM said it will use the cash to develop 50 new quantitative, multiplexed immunoassays for cancer-related proteins to add to its Human Multi-Analyte Profile platform.
 
RBM said its testing service, which is CLIA certified and supports Good Lab Practice studies, can generate data for hundreds of proteins "from a small sample volume and from multiple species."
 

 
Power3 Hires Middle East Distributor for Proteomic-Based Breast Cancer Dx
 
Power3 Medical Products said this week it has hired Bahrain-based Financial Advisory House to market and distribute a proteomics-based breast cancer test in 12 countries in the Middle East.
 
Under the agreement, FAH’s Medical Equipment Suppliers division will market and distribute Power3’s BC-SeraPro breast cancer diagnostic in Bahrain; Egypt; Iraq; Jordan; Kuwait; Lebanon; Saudi Arabia; Oman; Qatar; Syria; the United Arab Emirates; and Yemen.
 
BC-SeraPro is a proteomics-based blood serum diagnostic used for the early screening and diagnosis of breast cancer. FAH will market and distribute it to clinics and physicians in these countries, while the tests will be analyzed in Power3's Houston-based CLIA lab.
 
Financial terms of the agreement were not released.
 
“We selected the Middle East as our initial market because the healthcare systems in these particular countries are open to providing a test that offers new and innovative technologies for earlier detection of breast cancer,” Power3 CEO Steven Rash said in a statement.
 
The company also is seeking other distributors for the blood serum-based breast cancer test and is involved in discussions with international and domestic partners, it said.
 

 
Agendia to Develop Array-Based Dx for Herceptin Resistance
 
Agendia this week said it has acquired the rights to the discovery of a “major mechanism” of resistance to the breast cancer drug Herceptin, and plans to develop a microarray-based diagnostic that can identify resistance-associated biomarkers.
 
Agendia said it has acquired the rights to use the Herceptin-related biomarker method, which is detailed in a study written by CSO Rene Bernards that appears in the Oct. 15 issue of the journal Cancer Cell.
 
Herceptin targets the HER2 protein, which is involved in around a quarter of all breast cancer cases and contributes to the aggressiveness of the disease. And although around a quarter of patients treated with the drug together with traditional chemotherapy have shown “striking initial responses,” a majority become resistant to the treatment, the company said.
 
According to Agendia, the technology relies on RNAi to simultaneously inactivate thousands of genes in cells that are sensitive to a specific cancer drug. “If the inactivation of a specific gene confers resistance to a cancer drug, cells harboring the inactivated gene can continue to grow in the presence of the cancer drug and can be readily identified,” the company said in a statement.
 
In the Cancer Cell study, researchers identified the phosphatidylinositol 3-kinase pathway as a “major mechanism” of unresponsiveness to Herceptin-based therapies. According to Agendia, the pathway is mutated in up to half of all breast cancer tumors.
 

 
HiFi DNA Sues FDA for Dragging Feet on Reclassifying HPV Dx
 
HiFi DNA Tech said this week that it filed a lawsuit against the US Food and Drug Administration last week for allegedly failing to respond in time to the company’s petition to reclassify DNA tests for human papillomavirus from class III to class II devices.  
 
The Trumbull, Conn.-based company, which makes reagents and has developed a PCR-based HPV genotyping methodology, said the agency is required to either approve or deny such petitions within 210 days under the Federal Food, Drug and Cosmetic Act. The company filed its petition to reclassify the test in May.
 
The agency's "inaction" blocks the availability of newly developed molecular diagnostic tests and may be hindering women from accessing treatment and slowing therapeutic decision-making, President Sin Hang Lee said in a statement.
 
“Reclassification of HPV tests as class II in vitro devices will encourage small innovative companies to use the less burdensome 510k applications to introduce their new technologies for more accurate HPV testing on a competitive basis," Lee added.
 

 
Genomic Health’s Oncotype DX Yields Positive Results in Postmenopausal Women
 
Genomic Health last week said its Oncotype DX showed positive results in predicting the likelihood of recurrent breast cancer in postmenopausal women.
 
The test is currently used to predict recurrence and the likelihood of benefit from chemotherapy in women with estrogen-receptor positive, node-negative breast cancer.
 
The study in postmenopausal women, conducted by the Southwest Oncology Group, a National Cancer Institute clinical trials cooperative group, will be submitted for presentation at the 30th Annual San Antonio Breast Cancer Symposium in December.
 

According to a report in the Associated Press, Cantor Fitzgerald analyst George Zavoico said the new indication, if approved, would increase the number of patients eligible for the test annually by as much as 20 percent, to between 125,000 and 145,000 from between 100,000 and 120,000.

Filed under

The Scan

And Back

The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database.

Lacks Family Hires Attorney

A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports.

For the Unknown

The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona.

PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations

In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.