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 | DTTR August 2008 (full PDF issue) |
| TOP OF THE NEWS
California cracks down on DTC testing
Monogram enters oncology market
BUSINESS NEWS
Invitrogen to merge with Applied Biosystems
J&J acquires Swedish IVD company
Dako, Bristol-Meyers partner on companion diagnostics
Rosetta Genomics buys Pennsylvania lab
SCIENCE/TECHNOLOGY
BD’s C. difficile test gets CE Mark
Biomarker-based test predicts prostate cancer recurrence
Elevated liver protein linked to diabetes risk
Urinary albumin tied to hypertension
Boston researchers get grant for breast cancer biomarker discovery
INSIDE DIAGNOSTICS INDUSTRY
DTC genetic testing under state scrutiny
REGULATORY NEWS
FDA sends manufacturers ASR ‘reminder’ letters
CMS adds new waived tests to fee schedule
FINANCIAL NEWS
IVD stocks down 9%
G-2 INSIDER
See you at Lab Institute!
Full Article |
| Monogram Launches Breast Cancer Assay |
| Molecular diagnostics company Monogram Biosciences (South San Francisco, Calif.) is launching its first oncology product. Beginning July 15, the company will offer HERmark, a test that quantifies HER2 protein expression in patients with breast cancer to determine whether each can benefit from the drug Herceptin (trastuzumab). The HERmark test will be marketed to physicians nationwide and performed at Monogram’s College of American Pathologists (CAP)-certified clinical laboratory. List price for the test is $3,350, and turnaround time is seven days.
Full Article |
| California Cracks Down on DTC Genetic Testing |
| The California Department of Public Health (CDPH) is cracking down on companies offering direct-to-consumer (DTC) genetic testing, including such Silicon Valley "personal genomics" startups as 23andMe (Mountain View, Calif.), which promises individuals "deeper insights into personal ancestry, genealogy, and inherited traits" in return for $999 and a saliva sample. In June, CDPH sent notices to 13 laboratories to cease and desist performing genetic testing for California residents until the laboratories meet the requirements specified in state laws.
Full Article |
| Invitrogen, Applied Biosystems to Combine in $6.7B Deal |
| Invitrogen (Carlsbad, Calif.) and Applera (Norwalk, Conn., and Foster City, Calif.) have agreed to combine in a deal that would create a biotechnology reagents and systems giant with approximately $3.5 billion in combined sales and 9,700 employees. Under the terms of the agreement approved in June, Invitrogen will acquire all of the outstanding shares of Applera’s Applied Biosystems Group (AB) in a cash and stock transaction valued at $6.7 billion. Following the close of the transaction, expected this fall, the combined organization will be called Applied Biosystems and will be headquartered in Carlsbad.
Full Article |
| J&J Acquires Swedish IVD Company |
| Johnson & Johnson’s Nordic unit (Sollentuna, Sweden) has acquired Amic (Uppsala, Sweden), a developer of in vitro diagnostic (IVD) technology for use at the point of care, to bolster J&J-owned Ortho-Clinical Diagnostics. Johnson & Johnson expects to incur an estimated one-time after-tax charge of approximately $40 million during the second quarter of 2008 related to the deal. Other details of the transaction were not disclosed.
Full Article |
| BD’s C. difficile Molecular Test Gets CE Mark |
| BD Diagnostics, a segment of Becton, Dickinson, and Company (BD; San Diego, Calif.), has received the CE mark for its molecular test for the rapid diagnosis of Clostridium difficile infection. BD has submitted the assay to the U.S. Food and Drug Administration for clearance. List price is $49.50 per test.
Full Article |
| DTC Genetic Testing Under Greater Scrutiny |
| The California Department of Public Health (CDPH) is following the lead of the New York State Department of Health in cracking down on companies that offer genetic tests directly to consumers (DTC). In June, CDPH sent notices to 13 companies (listed below) ordering them to cease and desist performing genetic testing for California residents until they meet state laws that 1) require that all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination possess a clinical laboratory license or registration; and 2) prohibit the offering of a clinical laboratory test directly to the consumer without a physician order, unless specifically exempt.
Full Article |
| FDA Sends ASR ‘Reminder’ Letters to IVD Manufacturers |
| In June, the United States Food & Drug Administration’s (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Device and Radiological Health, sent a letter to manufacturers who have listed analyte specific reagents (ASRs) with the FDA, reminding them to ensure that their Class II or Class III in vitro diagnostic devices that are currently inappropriately labeled and marketed as ASRs comply with the law by September 15 of this year.
Full Article |
| Rosetta Genomics Buys Parkway Clinical Labs for $3m+ |
| To amplify the marketing and development of its microRNA-based tests, Rosetta Genomics (Jersey City, N.J.) has acquired Parkway Clinical Laboratories (PCL; Bensalem, Pa.) in a deal potentially worth $3.1 million. PCL’s revenues in 2008 are expected to be close to $3 million, putting the acquisition price at a 1.1x revenue multiple.
Full Article |
| Dako Partners With Bristol-Myers Squibb for Companion Diagnostics |
| Issue-based cancer diagnostics company Dako (Glostrup, Denmark), which was purchased last year by Sweden-based private equity group EQT, has announced a collaboration with Bristol-Myers Squibb (New York, N.Y.). Dako will develop clinical diagnostics to identify cancer patients who may receive greater benefits from certain drugs being developed by the pharmaceutical giant.
Full Article |
| Elevated Fetuin-A Levels Associated With Increased Diabetes Risk |
| Having a higher than normal level of fetuin-A, a protein produced in the liver and secreted into the blood stream, is associated with an increased risk of developing diabetes, according to a study published in the July 9 issue of the Journal of the American Medical Association.
Full Article |
| New Biomarker-Based Test Predicts Prostate Cancer Recurrence |
| According to research published in the June 15 issue of Clinical Cancer Research, the presence of seven biomarkers can predict with 86.6 percent reliability whether a patient who has had prostate cancer surgery will have a recurrence or spread of the disease. This is at least 15 percentage points higher than standard clinical measures currently in use, the researchers say.
Full Article |
| Urinary Albumin Levels Can Predict Hypertension |
| Healthy individuals with higher levels of albumin excretion, even levels considered normal, are at increased risk of developing high blood pressure (hypertension), according to a study that will appear in the October 2008 issue of the Journal of the American Society Nephrology (JASN) and was published online in late June. The study suggests that to prevent cardiovascular disease, the definition of "normal" urinary albumin excretion should be reconsidered.
Full Article |
| CMS Adds More Waived Tests to Lab Fee Schedule |
| Not waiting for the next annual update of the Medicare clinical lab fee schedule, the Centers for Medicare and Medicaid Services is adding 13 more waived tests to the schedule, effective July 1 with an implementation date of July 7. The tests are the latest approved by the Food and Drug Administration as waived under CLIA (the Clinical Laboratory Improvement Amendments).
Full Article |
| Boston Researchers Awarded Grant for Breast Cancer Biomarkers |
| Massachusetts General Hospital (MGH) and Northeastern University’s Barnett Institute have received a three-year, $1.26 million grant from Susan G. Komen for the Cure (Dallas, Texas) to carry out novel breast cancer research. Researchers from both institutions will use the joint award to discover protein biomarkers that can predict which women with benign diagnoses will go on to develop breast cancer and which will remain cancer free.
Full Article |
| IVD Stocks Fall 9%; Third Wave Rises on Takeover News |
| The 18 stocks in the G-2 Diagnostic Stock Index fell an average of 9 percent in the five weeks ended July 3, with 14 stocks down in price, two up, and two unchanged. The G-2 index is down 18 percent so far this year, while the Nasdaq is down 14 percent and the S&P 500 has fallen 13 percent.
Full Article |
| See You at Lab Institute! |
| Lab Institute 2008 to Tackle Changing of the Guard . . . Join Washington G-2 Reports for its 26th annual Lab Institute, September 17-19 at the Crystal Gateway Marriott in Arlington, Va. This year’s program, "Changing of the Guard: Working With a New Administration, the New Millennial Generation, and a New Health Care System," examines fundamental realignments in politics, Medicare and health care reform policy, personalized medicine, and the molecular diagnostics market. At this year’s Lab Institute, you will:
Full Article |
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