Becton Dickinson & Co. and Laboratory Corp. of America Holdings (Labcorp)are teaming up to develop, market and commercialize flow cytometry-based companion diagnostics (CDx) for cancer and other diseases. The agreement also paves the way for BD and Labcorp to collaborate with pharmaceutical partners.
A new assay developed by Metadeq Inc. may be bringing the days of the invasive liver biopsy for non-malignant conditions to a close. The company’s liquid biopsy successfully used the presence of two proteins in blood to identify and stage non-alcoholic steatohepatitis (NASH) and liver fibrosis in a study published in Gut.
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.
Quidel Corp. reported a definitive agreement to acquire Ortho Clinical Diagnostics Holdings plc in a nearly $6 billion deal expected to close in the first half of 2022. The $24.68 per share offered by Quidel represents a nearly 25% premium over Ortho’s closing price as of Dec. 22.Quidel will also assume $2 billion in debt.
In addition, Laboratory Corp. of America Holdings (Labcorp) said it would acquire Baltimore-based Personal Genome Diagnostics Inc., which offers a portfolio of genomics-based liquid biopsy and tissue-based diagnostic products, for $450 million in cash at closing plus up to $125 million contingent on achieving specific performance milestones. That deal is also expected to close in the first half of 2022, pending approval by both companies’ shareholders.
The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists.
Laboratory Corporation of America Holdings (Labcorp) further consolidated its position as a leading provider of rheumatoid arthritis testing with a definitive agreement to acquire the Vectra assay from Myriad Genetics Inc. along with other assets of the Salt Lake City-based company’s autoimmune business unit in a deal valued at $150 million in cash. The transaction is expected to close by the end of the third quarter of 2021.
Laboratory Corporation of America Holdings (Labcorp) reported its financial performance for the fourth quarter of 2020, which included a jump in revenues of 52%, a result enabled in part by its quick response to the COVID-19 pandemic. However, Labcorp said that revenues related to pandemic testing could decline by anywhere from 35% to 50% over the course of calendar year 2021.
