Subscribe Now
 Already a subscriber? Log-in!
Diagnostic Testing & Technology Report contains up-to-the-minute information and unique perspectives on where diagnostic testing is headed, covering every innovation, new product, manufacturer, market and end-user application. Each monthly issue provides an unbeatable blend of news, analysis, statistics, and forecasts.
Keep up with the latest trends in esoteric lab testing and what the hottest new tests are worth to your bottom line. Plus, find out about the strategies that individual companies are implementing now to win the fight for specific local markets and which sector has the most potent resources and best game plan for the long term.
|
|
|
 |
 | DTTR February 2007 (full PDF issue) |
| TOP OF THE NEWS
Siemens, GE Build Diagnostic Powerhouses
FDA to hold IVDMIA meeting
SCIENCE/TECHNOLOGY
New ACOG screening guidelines
FDA approves Chagas disease test
Screening newborns for SCID
MERGERS & ACQUISITIONS
Pfizer buys Genizon diagnostic rights
Luminex to buy Tm Bioscience
BD closes on TriPath Imaging
REIMBURSEMENT
Aetna, United will reimburse for OncotypeDX
JAMA study links reimbursement, clinical value of colon cancer screening
INSIDE DIAGNOSTICS INDUSTRY
Pharmacogenomics: Believe the hype?
PEOPLE
Epigenomics chooses new CEO
FINANCIAL NEWS
IVD stocks up 20% in 2006
G-2 INSIDER
Molecular diagnostics: the conference
Full Article |
| FDA to Hold Meeting on IVDMIA Draft Guidance |
| The Food and Drug Administration (FDA) Office of In Vitro Diagnostic Evaluation and Safety (OIVD) will hold a public meeting on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) on February 8 at 8:00 a.m. at the Hilton Washington, DC/Gaithersburg Hotel. The meeting is intended to provide a public forum during which OIVD will hear presentations and comments from interested stakeholders, regarding the draft guidance issued late last year, which is intended to provide clarification on FDA’s approach to regulation of in vitro diagnostic multivariate index assays.
Full Article |
| Siemens, GE Build Diagnostic Powerhouses |
| The medical division of the industrial conglomerate Siemens (Berlin and Munich, Germany) has completed its purchase of Bayer Healthcare’s diagnostic division and merged it with Diagnostic Products Corporation (DPC), which Siemens Medical Solutions acquired last July, to create Siemens Medical Solutions Diagnostics. The new entity is headquartered in Tarrytown, New York, and Los Angeles, California, and has approximately 8,000 employees. The business will be led by CEO Anthony Bihl, who previously served as president of Bayer’s diagnostics division.
Full Article |
| New ACOG Guidelines Urge Earlier Screening for Down Syndrome |
| The American College of Obstetricians and Gynecologists (ACOG) now recommends universal screening for Down syndrome and other fetal chromosomal abnormalities in the first trimester of pregnancy, according to revised clinical management guidelines published in this month’s issue of Obstetrics & Gynecology. Down syndrome, the most common major chromosomal abnormality in the United States, occurs in about 5,000 infants each year.
Full Article |
| Pfizer Buys Diagnostic Rights for Genizon’s Disease Markers |
| Change is afoot at the world’s largest drug company. After safety concerns led Pfizer (New York, NY) to halt development of Torcetrapib, the blockbuster cholesterol drug in which it invested $800 million, the company has been scrambling to refocus itself. As Pfizer seeks to fill the gaps in its pipeline, it is hungry for acquisitions in the areas of "diabetes, neurology, infectious disease, and oncology that combined have a worldwide market potential significantly in excess of $200 billion," according to management.
Full Article |
| Initiative Seeks Routine SCID Screening for Newborns |
| A new initiative is laying the groundwork to add severe combined immune deficiency disease (SCID) to the 47 existing screening parameters in Wisconsin’s newborn screening program. Several other states are expected to follow Wisconsin’s lead. SCID, often called "the bubble boy disease," is one of the most lethal primary immune deficiency diseases. The defining characteristic is usually a severe defect in both the T- and B-lymphocyte systems. Because physicians do not routinely perform a test in newborns to count white blood cells, early diagnosis of SCID is rare.
Full Article |
| FDA Approves Ortho-Clinical’s Chagas Disease Screening Test |
| The U.S. Food and Drug Administration (FDA) has approved the first test to screen blood donors for Chagas disease, also known as American trypanosomiasis, a potentially fatal parasitic infection. The ORTHO T. cruzi ELISA test system, manufactured by Johnson & Johnson subsidiary Ortho-Clinical Diagnostics (Raritan, NJ), qualitatively detects antibodies to the Trypanosoma cruzi parasite in serum and plasma. The test is not yet approved to diagnose the disease.
Full Article |
| Genomic Health Gets United, Aetna Reimbursement for Oncotype DX |
| Genomic Health (Redwood City, CA) has signed national contracts with both United Healthcare (Minnetonka, MN) and Aetna (Hartford, CT) for Oncotype DX, the company’s flagship test that quantifies the likelihood of breast cancer recurrence and predicts the likelihood of chemotherapy benefit for many early-stage breast cancer patients.
Full Article |
| Pharmacogenomics: Are Labs Believing the Hype? |
| Slowly, test by test, the clinical laboratory industry is entering the field of pharmacogenomics, or what is often called "personalized medicine" or "predictive medicine," the use of advanced molecular diagnostic tools to tailor therapeutics.
Full Article |
| Epigenomics Chooses New CEO, Contracts With Centocor for Cancer Biomarkers |
| Molecular diagnostics company Epigenomics (Berlin, Germany), which specializes in cancer testing using DNA methylation markers, will appoint Geert Walther Nygaard as its new CEO on February 1. Nygaard, 46, joins Epigenomics from Abbott, where he served as managing director and a member of the management board and was responsible for the diagnostic division. A native of Denmark, Nygaard previously held positions with Beckman Instruments and Dako. Alexander Olek, the founder of Epigenomics, stepped down from his position as CEO in August of last year.
Full Article |
| JAMA Study Links Expanded Medicare Reimbursement With Increased Colon Cancer Screening, Earlier Diagnosis |
| Since Medicare’s 1998 reimbursement expansion for colon cancer screening, more Medicare beneficiaries are getting colonoscopies and patients are being diagnosed with colon cancer at an early stage, according to a study published in the December 20 issue of the Journal of the American Medical Association (JAMA). Before 1998, Medicare did not routinely reimburse for colon cancer screening, and many have pointed to this as a barrier to widespread screening and early detection.
Full Article |
| BD Closes on $350m TriPath Acquisition |
| Global medical technology company Becton, Dickinson, and Company (BD; Franklin Lakes, NJ) has closed on its $350 million purchase of the approximately 93.5% of outstanding shares in TriPath Imaging (Burlington, NC), a leading player in the increasingly crowded market for cervical cancer screening. BD has held a 6.5% equity interest in TriPath since 2001, when the two companies began their ongoing collaboration to discover cancer biomarkers.
Full Article |
| Luminex to Buy Tm Bioscience for $37.9M |
| Molecular diagnostics company Tm Bioscience (Toronto, Canada) has been acquired by Luminex (Austin, TX), best known for its xMAP testing platform. Under the terms of the agreement, valued at $37.9 million, each Tm Bioscience share will be exchanged for 0.06 shares of Luminex common stock. This represents a 41.5% premium for Tm shares based on the stock’s closing price on the day of the acquisition. The transaction is expected to close in the first quarter of this year.
Full Article |
| IVD Stocks Rose 20% in 2006 Led by Immucor, Cholestech, Digene |
| The 21 IVD stocks in the G-2 index climbed an unweighted average of 20% last year versus respective gains of 14% and 10% for the S&P 500 Index and the Nasdaq.
Full Article |
| Molecular Diagnostics: The Conference |
| Make 2007 the year that your lab puts molecular diagnostics to work! Learn key strategies for success at Washington G-2 Reports’s 2nd Annual Molecular Diagnostic Conference: Integrating MDx Into Your Lab, Feb. 7-9, 2007, at the Renaissance Tampa Hotel International Plaza in Tampa, Florida. This year’s conference will focus on how to leverage molecular diagnostic manpower, intellectual property, and novel technology.
Full Article |
|
|
Please choose an archived issue to view newsletter table of contents above
|
|
