QUIDEL Receives FDA Clearance to Market New, Rapid Pregnancy Tests
SAN DIEGO, Dec. 18 /PRNewswire/ -- QUIDEL Corporation (Nasdaq: QDEL - news) today announced it has received U.S. Food and Drug Administration (FDA)
clearance to market two new tests designed for use in the clinical laboratory market that detect human chorionic gonadotropin (hCG), the hormone produced during
pregnancy.
Over 45 million tests for hCG are performed each year in doctors' offices, clinics and emergency rooms generating a market estimated at $50 million dollars annually.
hCG is a hormone produced by the placenta shortly after implantation of a fertilized egg. It is present in the serum and urine of pregnant women, making it an excellent
market for confirming pregnancy. These new products from Quidel have an enhanced low-end sensitivity that make them excellent choices for clinical use where the
determination of an unknown pregnancy can prevent unnecessary procedures from being performed on the mother that could be harmful to the fetus.
These new tests are greater than 99% accurate. Test results are available in minutes after the addition of sample with no additional reagents or steps required.
The new products are to be sold under the brand names, QuickVue(R) One- Step hCG-Combo, CARDS(R) QS(R) hCG Serum/Urine and CONCISE(R) Performance
Plus(TM) hCG-Combo. These tests offer added conveniences over the two current market leaders, such as no pre-treatment of serum samples and room temperature
storage. The CARDS QS and CONCISE Performance Plus brands also provide test results in the universally recognized ''+'' sign for a positive results and a ''-'' sign
for a negative result.
QUIDEL Corporation discovers, develops, manufactures and markets rapid immunodiagnostic products for point-of-care detection of human medical conditions and
illnesses. These products provide accurate and cost-effective diagnoses of acute and chronic conditions in the areas of reproductive and women's health, infectious
diseases, allergies and autoimmune disorders. QUIDEL's products are sold to professionals in the physician's office and clinical laboratory under the QuickVue, CARDS
QS and CONCISE Performance Plus brandnames, as well as to consumers through retail drug stores under the brandnames Conceive(R), QTest(R), RapidVue(R),
OvuQuick(R) and OvuKit(R).
SOURCE: QUIDEL Corporation |
