NEW YORK – LumiraDx said this week that its SARS-CoV-2 Antigen test has received emergency use approval from India's Central Drugs Standard Control Organisation for use in that country. The test received Emergency Use Authorization from the US Food and Drug Administration in August 2020 and CE marking a month later. It detects antigen nucleocapsid protein from a nasal swab and provides results in 12 minutes, the London-based firm said.
Mesa Laboratories said this week that it has closed its $300 million acquisition of Agena Bioscience. Agena is expected to add between $63 million and $67 million of revenues to Mesa during the first 12 months of the deal, with high single digit organic revenue growth over the next several years, Mesa said. The company also noted that Agena is expected to add $3 million to $5 million of COVID-19-related revenues during the first year of the deal.
Lucid Diagnostics said this week it has closed its initial public offering of 5 million shares of common stock at $14 per share, for gross proceeds of $70 million. The firm also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its stock at the IPO price, minus underwriting discounts and commissions. Cantor and Canaccord Genuity acted as the joint bookrunning managers for the offering, while BTIG and Needham acted as the co-lead managers.
Bioinformatics firm Deep Lens and health system Ocala Oncology/Florida Cancer Affiliates announced this week that they would expand their clinical research program using Deep Lens' artificial intelligence-based clinical trial matching solution, Viper. Ocala Oncology/Florida Cancer Affiliates is aiming to make more clinical trials available to its patients using Deep Lens' technology to automate identification of eligible patients. Viper will integrate with the health system's EMR to identify patients at diagnosis and integrate pathology feeds and molecular data feeds from Caris Life Sciences, Foundation Medicine, and Guardant Health.
Digital health firm Everly Health this week announced the acquisition of Natalist, a women's health company that provides conception and pregnancy products for consumers. Specific terms of the all-cash transaction were not disclosed.
Natalist's products expand Everlywell's existing women's health offerings, which currently include at-home collection lab tests for menopause, fertility hormones, and sexual health, Everly Health said. In addition to its signature pregnancy and ovulation tests, Natalist's product suite supports women from pre-conception through pregnancy and includes tests, supplements, education, lubricants, and self-care items. Natalist is Everly Health's third acquisition this year.
In March, Everlywell acquired telehealth company PWNHealth and its subsidiary Home Access Health for an undisclosed amount, and subsequently formed Everly Health.
Biological Dynamics said this week that the US Food and Drug Administration has granted breakthrough device designation for its liquid biopsy assay, Exo-PDAC. The test is designed to provide early detection for pancreatic ductal adenocarcinoma by identifying exosomal biomarkers.
Exo-PDAC is the first assay to use Biological Dynamics’ Verita platform, an alternating current electrokinetic-based technology, which the firm is exploring for cancer, Alzheimer’s disease, and infectious disease detection. The test requires a small amount of blood from patients, which is then analyzed with minimal sample preparation or processing.
Diagnostic testing company Plexision announced this week that it has received accreditation from the College of American Pathologists for its CLIA-certified reference laboratory in Pittsburgh. The lab performs cell-based blood tests for management of transplant rejection, infections in immunocompromised patients, and immune therapy in oncology. The firm’s tests can also be used to determine disease risk for several immunological disorders and develop personalized dosing recommendations.
Verogen and Cellmark Forensic Services this week announced a partnership to offer next-generation sequencing-based forensic services. Cellmark has received ISO17025 accreditation from the UK Accreditation Service for NGS-based forensic DNA analysis. It will use Verogen's ForenSeq DNA Signature Prep Kit and the MiSeq FGx sequencing system.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.