February 25, 2020
Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce the availability of its new CRYOcheck Hex LA™ kit in Canada, the European Union, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities.
CRYOcheck Hex LA is intended for use in clinical labs to aid in the detection of lupus anticoagulants (LA) in human plasma. Hex LA is an integrated (screen and confirm) assay and, as its name suggests, applies hexagonal phase phospholipids. It is the first commercially available hexagonal phase LA test available in a frozen format, allowing for fast and easy preparation. Designed to work on many common automated coagulation analyzers, Hex LA offers valuable time savings to today’s busy labs.
CRYOcheck Hex LA is Precision BioLogic’s second product to launch this year. Coinciding with its release is the introduction of a third product, CRYOcheck Lupus Negative Control. Hex LA and Lupus Negative Control are the latest additions to Precision BioLogic’s suite of LA testing products, which includes LA Check™ (a dRVVT screening reagent), LA Sure™ (a dRVVT confirmatory reagent), Platelet Lysate, and two lupus positive controls.
“The launch of Hex LA rounds out our LA offerings and illustrates our commitment to bringing novel solutions to clinical hemostasis labs,” says Paul Empey, President & CEO of Precision BioLogic.
Precision BioLogic has submitted a premarket notification 510(k) for the device to the U.S. FDA for clearance and is actively pursuing other opportunities to innovate in the field of hemostasis and diagnostics.
About Lupus Anticoagulant
Lupus anticoagulants (LA) are autoantibodies produced by the immune system, which mistakenly attack certain components of the body's own cells. LA interferes with the blood clotting process and increases a person's risk of developing a blood clot, which can lead to stroke, heart attack or pulmonary embolism. LA is also associated with recurrent miscarriages. There is no gold standard test for the detection of LA, and it cannot be measured directly. Given the complexity of LA, its presence is often determined using a series of tests. There is no cure, however, there are treatments to help decrease the risk of excessive clotting.
About Precision BioLogic
Precision BioLogic Inc. is a privately-held company that develops, manufactures and markets the CRYOcheck™ line of frozen products used by medical professionals and researchers around the globe to diagnose coagulation disorders. Precision BioLogic also has several active initiatives with pharmaceutical partners who seek to ensure that the diagnostic implications for their novel therapeutic agents have been well characterized. In November 2018, Precision BioLogic acquired Affinity Biologicals, enabling the company to expand its clinical and research offerings to include an extensive line of coagulation-related antibodies as well as other products and services. For more information, visit www.precisionbiologic.com.