BIOMERICA LAUNCHING PRIVATE LABEL OTC PREGNANCY TESTS modeled after Warner-Lambert's e.p.t. home pregnancy test and Johnson & Johnson's Fact Plus. Newport Beach, California-based Biomerica plans to begin shipping Fortel Midstream, a knock-off of e.p.t., and Fortel Plus, designed after J&J's product, during the first half of 1994. Biomerica's two new tests were among a number of new entries into the OTC testing market announced at the Private Label Manufacturers Association's annual trade show in Chicago Nov. 14- 17. Other private label versions of over-the-counter pregnancy tests launched at the trade show included Clinical Diagnostics, Inc.'s Sure Check and Qualis' Bio-Sentry one-step pregnancy tests. Biomerica's Fortel Midstream is comprised of a test stick and a desiccant (drying agent) and requires no urine collection, Biomerica said. The test stick features two viewing windows -- a control window that shows whether the test is working properly and a larger test window that shows the results of the test. On the other side of the test stick from the viewing windows are two absorbent windows through which a consumer urinates to begin the test; the stick must be held in the urine stream for at least six seconds to function properly. At five minutes, a result can be read in the viewing windows -- a rose/pink color band will appear in the test window if the result is positive; the absence of a color band indicates a negative result. Fortel Plus contains a test device, a urine dropper and a moisture-absorbent packet. Consumers are directed to collect urine in a cup, fill the dropper with urine and deposit six drops of urine into a well on the test device. After five minutes, a color band appears in a control window to indicate that the test has been completed; the test is invalid if the color band does not appear. As with the Fortel Midstream, the presence of a color band in the test window indicates a positive result, while the absence of a color band signifies a negative result. Biomerica estimated Fortel Midstream will carry a retail price of $8.99 while Fortel Plus will be priced around $6.99. According to Biomerica, e.p.t. and Fact Plus tests are retail priced at $12.99 and $13.99, respectively. Biomerica primarily manufactures and markets in vitro diagnostics for the physician's office and clinical laboratory markets. The company entered the OTC test market in 1991 with EZ Detect tests for hidden blood in the stool and urine. Chester, South Carolina-based Clinical Diagnostics' Sure Check one-step pregnancy test is copied from J&J's Fact Plus. Clinical Diagnostics expects to make the product available both under the Sure Check control name as well as to private label customers. Qualis' Bio-Sentry one-step home pregnancy test is expected to begin shipping to retailers in the beginning of January. In addition to being offered under the Bio-Sentry name, the test will be available to private-label customers including several "major chains," the company said. The Bio-Sentry test also is modeled after J&J's Fact Plus home pregnancy test. The OTC pregnancy test is Qualis' first foray into the home diagnostics market. The Des Moines-based company mostly manufactures personal care and dermatological OTCs, particularly focusing on "niche" products such as lice treatment items, medicated powders and antiseptic skin cleansers.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
