Progenity, Inc. Reaches Two Million Test Milestone
January 20, 2021 at 12:30 pm
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Progenity, Inc, has reported the completion of two million diagnostic tests by its CLIA-certified and CAP-accredited laboratory in Ann Arbor, Michigan. This notable milestone comes as Progenity celebrates the ten-year anniversary of the company’s founding. Progenity was established in 2011 as a women’s health molecular diagnostics company offering a genetic carrier test for the detection of cystic fibrosis. the company has commercialized a portfolio of diagnostic products, including the Preparent® Carrier Test for hereditary genetic diseases; the Innatal® Prenatal Screen for chromosomal disorders; the Riscover® Hereditary Cancer test, and the Resura® Prenatal Test, which provides noninvasive prenatal screening for monogenic diseases. Progenity’s preeclampsia rule-out test, Preecludia™, has the potential to be the first test in the United States to help healthcare providers evaluate patients who have symptoms of possible preeclampsia, a potentially deadly condition for both pregnant mothers and their babies. This novel protein biomarker assay is designed to address the unmet need for tools to aid in the triage and management of preeclampsia. The Preeclampsia Foundation recently issued a national call to action for the development of biomarker tests specific to the pathophysiology of preeclampsia due to this unmet need. Last November, the company released strong verification performance data for Preecludia and plan to enter validation later in Q1, followed by a targeted launch in the second half of 2021. Progenity is also building upon its core competencies in molecular testing by developing and commercializing a disruptive platform of gastrointestinal (GI) health diagnostics and targeted therapeutics. Leveraging a proprietary autonomous localization technology, Progenity is developing a noninvasive, ingestible capsule technology platform, with investigational devices and drug/device combinations designed for both diagnostic and therapeutic purposes. Progenity believes product candidates, if successfully developed and approved or cleared, could become the first precision medicine products to diagnose and treat at the site of disease within the GI tract.
Biora Therapeutics, Inc. is a biotechnology company, which is focused on creating smart pills designed for targeted drug delivery to the gastrointestinal (GI) tract, and systemic, needle-free delivery of biotherapeutics. The Companyâs pipeline includes two therapeutic delivery platforms: NaviCap and BioJet. The NaviCap, targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract. The BioJet, systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules. It has two demonstration drug-device combination programs for the BioJet platform, BT-200 (GLP-1 receptor agonist) and BT-002 (adalimumab variant). Its other two programs include BT-600 (NaviCap + tofacitinib) and BT-001 (NaviCap + variant of adalimumab) for the treatment of ulcerative colitis.