Celltrion Inc. recently received FDA emergency use authorization (EUA) for its Diatrust COVID-19 Ag home test. “With the FDA approval, we will now prioritize getting the test kits to the U.S. and into users’ hands as soon as possible,” a spokesperson for the Incheon, South Korea-based Celltrion told BioWorld. The test kits will be distributed through Celltrion’s U.S. arm, Celltrion USA Inc. Celltrion is currently in the final stage of negotiations with the U.S. government, as well as online and offline distributors.

Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.

Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.

The parent company of digital health unicorn Everlywell Inc. is expanding its portfolio of women’s health products through the acquisition of Charleston, S.C.-based startup Natalist Inc. The purchase marks Everly Health’s third acquisition of the year following agreements to buy national clinician network PWN Health and home lab testing company Home Access Health Corp. Financial terms of all deals were not disclosed. Headquartered in Austin, Texas, Everly Health will add Natalist’s suite of reproductive products to its existing tests for menopause, fertility hormones and sexual health.

The COVID-19 testing rebound driven by the Delta variant’s extended surge pushed Abbott Laboratories’ earnings per share for the third quarter nearly 50% higher than consensus estimates. Sales climbed to $10.928 billion, up 15% from expected estimates of $9.564 billion. COVID-19 testing accounted for $1.9 billion in sales, but even without that boost, the company posted year-over-year growth of 11.7% compared to the third quarter of 2019. With COVID testing included, Abbott had organic sales growth of 22.4% compared to the same quarter of 2020 and up 35% compared to the third quarter of 2019. With the third-quarter results, the company announced an increase in the full-year guidance to $5 to $5.10, nearly 40% higher than last year.

Castle Biosciences Inc. is acquiring gastrointestinal (GI) diagnostics company Cernostics Inc. in a transaction valued up to $80 million. The deal marks a move from Castle’s focus on dermatology diagnostics to include GI disorders and could expand its estimated U.S. total addressable market by approximately $1 billion, the company said. Shares of Castle Biosciences (NASDAQ:CSTL) jumped 7.8% to close at $67.58 on Tuesday Oct. 19.

Patent subject matter eligibility has emerged as arguably the most controversial patent policy theme of the past two decades, one which has been most keenly felt in the world of in vitro diagnostics (IVDs). A new study pending publication suggests that venture capital (VC) investment in IVDs would have been $9.3 billion higher in the four years following the Supreme Court’s decision in Mayo v. Prometheus, a finding which the author said leads inevitably to the conclusion that the subject matter eligibility crisis “should receive Congress’ immediate attention.”

The FDA issued an Oct. 18 reminder to the diagnostics industry that the agency still requires test developers to register with an institutional review board (IRB) for all studies of human subjects. This still pertains to studies that make use of leftover, de-identified specimens in FDA-regulated studies, an alert to industry which suggests that enforcement actions may be in the near offing.

Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91.

LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies.