Acupath Laboratories Inc., of Plainview, N.Y., said it is expanding COVID-19 testing options with the introduction of a low-cost saliva polymerase chain reaction (PCR) assay. Acupath launched its FDA emergency use authorized COVID-19 real-time PCR assay in May 2020. The new saliva assay was developed in conjunction with Lighthouse Lab Services, of Charlotte, N.C.
Nashville-based Change Healthcare Inc. said its stockholders approved the previously announced combination with Optuminsight Inc., of Eden Prairie, Minn., a part of Unitedhealth Group Inc. Of the approximately 222 million shares voted at the April 13, 2021, special meeting of stockholders, 99.9% voted in favor of the merger agreement.
Cormedix Inc., of Berkeley Heights, N.J., said it met with the FDA to discuss proposed resolutions to deficiencies identified the complete response letter (CRL) to the company and the post-application action letter received by the third-party manufacturer from FDA for the NDA for Defen Cath (taurolidine/heparin catheter lock solution). There is now an agreed upon protocol for the manual extraction study identified in the CRL that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials.
Madison, Wis.-based Exact Sciences Corp. has completed its acquisition of Phoenix-based Ashion Analytics LLC from the Translational Genomics Research Institute, an affiliate of City of Hope. Financial terms were not disclosed.
Leiden, Netherlands-based Genscript Biotech BV, a subsidiary of Genscript Biotech Corp., and IES Diagnostics Inc., of Wayne, Pa., the life science division of IES Medical of Bilbao, Spain, have inked an agreement for the exclusive distribution of the Genscript Cpass SARS-CoV-2 Neutralization Antibody Detection Kit in Spain, Portugal and Andorra.
Paris-based HTL Biotechnology and Echelon Biosciences Inc., of Salt Lake City, Utah, have forged a partnership to enable distribution of high-quality hyaluronic acid and glycosaminoglycan (GAG), and the co-development of novel GAG products.
Inari Medical Inc., of Irvine, Calif., reported a global partnership with Tel Aviv-based Aidoc Medical Ltd. to accelerate the adoption and clinical impact of artificial intelligence to advance timely detection and treatment of pulmonary embolism.
Infinity Biologix LLC, a next-generation central laboratory headquartered in Piscataway, N.J., has been awarded a contract from the CDC to provide genomic sequencing and new variant identification of samples of SARS-CoV-2. IBX will sequence the viral genomes of random, de-identified samples in the U.S. that test positive while providing molecular diagnostic testing for SARS-CoV-2 for providers and patients, and will provide the CDC with completed whole viral sequences in order to aid in its large-scale longitudinal genomic survey of the virus. The CDC’s survey expects to provide baseline information for national and state-level surveillance, identify new variants, and ultimately improve the public health response in the U.S.
New York-based K Health and funds managed by Blackstone Growth, of New York, reported the formation of Hydrogen Health LLC to create digital-first health care solutions. The joint venture is also backed by an investment from Indianapolis-based Anthem Inc. Hydrogen Health will seek to lower health care costs by leveraging K Health’s artificial intelligence technology to bring digital-first health care to the employer and consumer markets.
Katena Products Inc., of Parsippany, N.J., a provider of ophthalmic instruments, biologics and devices, has acquired ophthalmic surgical instruments company Asico LLC, of Westmont, Ill.. Financial terms of the transaction were not disclosed.
PRA Health Sciences Inc., of Raleigh, N.C., said its subsidiary Care Innovations was selected by the Maryland State Medical Society (Medchi) to be a preferred provider of remote patient monitoring, telehealth and digital health services. Medchi is a nonprofit membership association of Maryland physicians.
Renalytix AI plc, of New York, entered an exclusive option agreement with Boston-based Joslin Diabetes Center for patent filings on certain additional biomarkers in kidney disease for development and deployment in the Kidneyintelx in vitro prognostic platform. Renalytix AI plans to begin evaluating these new biomarkers in expanded clinical validation studies beginning in the second half of 2021.
Twist Bioscience Corp., of South San Francisco, reported a partnership with Pure Biologics SA, of Wroclaw, Poland, to accelerate the discovery of immuno-oncology antibody-based drugs. Under the terms of the agreement, Twist Biopharma, a division of Twist Bioscience, will grant Pure Biologics’ access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging artificial intelligence and big data analytics.
Wellframe Inc., of Boston, and Validic Inc., of Durham, N.C., entered a strategic collaboration to integrate Validic’s medical device data within the Wellframe mobile app. This integration will enable Wellframe users to track their blood glucose levels across 50 glucometer devices.