NEW YORK — The US Department of Defense announced last week that it has awarded Hologic a $93.3 million fixed-price contract for the company's test kits with an estimated completion date of May 5, 2029. A Hologic spokesperson said that the contract will be used to order various assays including tests for sexually transmitted infections, virology, and respiratory diseases.
Infectious disease diagnostic firm Karius said this week that its Karius Test for diagnosing and managing lung infections in immunocompromised patients has received US Food and Drug Administration breakthrough device designation. The blood-based laboratory-developed test is a liquid biopsy that leverages metagenomic sequencing to detect more than 1,000 pathogens that cause bloodstream infections, Redwood City, California-based Karius said, adding that results can be achieved in one day. The company noted that clinical data that support use of the test include results from a clinical trial, which demonstrated that the Karius Test increased the relative yield for detecting the probable cause for pneumonia by 40 percent.
Quest Diagnostics this week released findings from an analysis of roughly 9.8 million workforce drug tests conducted by the lab company in 2023 that showed that overall drug positivity rates held steady year over year while marijuana positivity rose as did the rates of tampered, substituted, or invalid samples. Drug positivity in the general US workforce was 5.7 percent, flat with 2022. Marijuana positivity was 4.5 percent, up 5 percent from 4.3 percent in 2022. The rate of substituted samples rose 633 percent, to .11 percent from .015 percent in 2022, while the rate of invalid samples rose 45 percent to .45 percent from .31 percent in 2022. According to Quest, a result of substituted or invalid suggests a specimen has been tampered with in an attempt to conceal drug use.
Separately, Quest said this week that its board declared a quarterly cash dividend of $.75 per share, payable on July 22 to shareholders of record on July 8.
T2 Biosystems said this week it has closed its previously announced private placement, raising $8 million in gross proceeds. The financing will be used for working capital and other general corporate purposes, including sales and marketing, manufacturing, and clinical development purposes, the Lexington, Massachusetts-based developer of tests to detect sepsis-causing pathogens and antibiotic resistance genes said.
The Foundation Fighting Blindness said this week that it has partnered with PreventionGenetics, a unit of Exact Sciences, and InformedDNA to provide services for the My Retina Tracker genetic testing program. The initiative, launched in 2017, provides genetic testing and counseling at no cost to patients with a clinical diagnosis of inherited retinal diseases who meet certain eligibility criteria. So far, more than 20,000 individuals have received testing through the program. Under the new agreement, PreventionGenetics will serve as the testing laboratory, using a targeted gene panel, while InformedDNA will offer genetic counseling services. Previously, Blueprint Genetics, part of Quest Diagnostics since 2020, had been providing genetic testing for the program.
Fungal diagnostics company Immy of Norman, Oklahoma, said this week that it has acquired UK-based OLM Diagnostics for an undisclosed amount. OLM, founded in 2014, offers real-time PCR assays in different medical areas.
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.