Steve,
Thanks for the news about Chlamydia. Here are a couple links to the news release and some highlights from the articles, further evidence Quidel's sales are sure to increase:
CDC Urges Routine Chlamydia Screening Of Adolescent Girls reutershealth.com
". . . .Dr. Wasserheit says chlamydia screening and treatment "...should be a standard of care for sexually active adolescents and young adults," and she urges providers to make this a "...routine part of preventive healthcare." According to the CDC, untreated chlamydia infections and related complications cost roughly $2 billion in 1994 alone."
Screening an effective way to combat chlamydia, CDC says nando.net
". . . .The government said screening is the best way to stop chlamydia, a sexually transmitted disease that is the nation's most commonly reported infection. . . .It's also common among young men, who are seldom offered screening. . . .Chlamydia is easy to cure, but often goes undiagnosed because it seldom causes symptoms. As many as one in 10 infected women becomes infertile from it. Untreated chlamydia infections cost more than $2 billion a year. The CDC estimates national screening would cost about $175 million."
Also, recall Quidel's news release back in late 1995: Regarding the CDC Chlamydia Symposium: QUIDEL's Recently Introduced Chlamydia Test Among Fastest and Easiest to Use, New CDC Strategies to Benefit QUIDEL quidel.com
". . . Quidel commented on Wednesday's (11/8/95) satellite symposium on Chlamydia disease - diagnosis, treatment, and prevention - sponsored by the Centers for Disease Control and Prevention (CDC). The CDC identified non-laboratory methods of diagnosis, such as non-instrumented and in-office rapid antigen tests, which can facilitate early detection and cure. QUIDEL's recently introduced QuickVue Chlamydia Test offers the highest sensitivity and accuracy of any antigen test, with results in as little as 12 minutes. . . .Chlamydia affects an estimated one in twenty women under the age of 24 years. "We pay a very high price for Chlamydial infections both in terms of human costs and in terms of economic costs," said Judith N. Wasserheit, MD, MPH, Director of the CDC's Division of STD Prevention. "Three of the four long term or irreversible complications that make sexually transmitted diseases a central public health priority are caused by Chlamydia." In commenting on the medical costs to the U.S. health care system, Dr. Wasserheit said, "We estimate that routine screening and treatment of women at risk for Chlamydia and their male partners could save the United States up to $2.2 billion annually over the present cost of treating these women and their partners for the consequences that result when Chlamydia goes undetected." The CDC also indicated that the scenario for Chlamydia infections is improving. "The frequency, severe complications, and high cost of Chlamydia, combined with the availability of new diagnostic, therapeutic, and programmatic tools make effective management of this STD one of the most exciting and important opportunities that we've ever had to improve the health of women in this country," continued Dr. Wasserheit. Traditional detection of Chlamydia has involved culturing the organism in the laboratory. This lack of point-of-care testing, which delays results for several days, has been a contributing factor, along with Chlamydia's asymptomatic nature, in spreading the disease."
The CDC's not the only government body encourage screening. Look at what the German government did just last July according to Quidel's press release: QUIDEL Receives German Registration Approval for QuickVuer Chlamydia Test quidel.com
". . . Quidel announced today receipt of product registration approval from Germany's Paul Ehrlich Institute (PEI) for the QuickVue" Chlamydia Test. . . . The market for chlamydia testing in Germany is expected to double by the year 2000. The new QuickVue Chlamydia Test is a lateral flow immunoassay containing highly specific antibodies reactive to the Chlamydia organism. The test is a direct antigen test and offers superior performance advantages over products in use today. Fewer steps and faster results, combined with the highest sensitivity among rapid tests, enable doctors to perform immediate, in-office detection and treatment. . . ."With high infection rates among the general population and expectant mothers, the German government has established new reimbursement guidelines for chlamydia testing at the point of care in an effort to gain control of the disease and to improve prenatal care," said Steven T. Frankel, president and chief executive officer of QUIDEL. "This action has provided the catalyst for rapid market expansion of chlamydia testing in that country. Our QuickVue Chlamydia Test could become one of our largest selling products through our German subsidiary."
Also, check out Quidel's news release just last September about France granting expanded use for Quidel's rapid Chlamydia test: QUIDEL's Rapid Chlamydia Test Granted Expanded Use in France quidel.com
". . . Quidel today received approval from the Agence Du Medicament, the French government health agency, for expanded use of its QuickVuer Chlamydia Test with male urine samples. The test was previously approved for use with endocervical swabs only. Chlamydia infections are one of the most widely spread sexually transmitted diseases in the world and are a large and growing public health concern. . . .The expanded use of the QuickVue Chlamydia Test is an important prevention strategy because it allows for accurate diagnosis and treatment to be accomplished during a single doctor's office visit. "With the added ability to test male urine, an infected woman's partner may be more easily screened for chlamydia at the point of care to help prevent spreading the disease. This is a significant improvement over the traditional detection method used in males that utilizes a urethral swab," said Steven T. Frankel, President and Chief Executive Officer of QUIDEL. . . ."Because our test can be performed in-office and completed in minutes while the patient waits, treatment outcomes are improved by enabling doctors to immediately administer single-dose antibiotic therapy. In the past, doctors have had to wait sometimes days for lab results before following up with patients. Because most infected people do not have symptoms, it has been difficult to get patients to return for a prescription and to comply with the antibiotic regimes."
With the CDC now urging routine Chlamydia screening, recent German and French approvals and all Quidel's recent distributors on board with their mergers, it's pretty obvious Quidel's Chlamydia test market is expanding very fast.
I wouldn't be surprised to see Quidel soon announce a CLIA waived Chlamydia test.
Mike |