NEW YORK – ARUP Laboratories issued a public comment this week on the US Food and Drug Administration’s proposed rule for regulation of laboratory-developed tests, urging the agency to withdraw the rule. In its comment, the lab said it believes the rule uses flawed estimates regarding the number of LDTs ordered and their performance and also challenged the agency’s authority to regulate these tests. It said the rule would negatively impact patient care and reduce access to testing.
Thermo Fisher Scientific and Project HOPE said this week that they have partnered to expand access to HIV testing and support services in Nigeria. The partnership specifically advances Project HOPE's efforts in Northwestern Nigeria by expanding access to critical community HIV testing services, Thermo Fisher said in a statement. Project HOPE, supported by local community partners, will identify and help connect HIV-positive adolescents and young persons with appropriate treatment and essential social and economic support services. Additionally, Thermo Fisher will engage its employees in volunteer opportunities to augment Project HOPE's services, the partners said.
Centogene said this week that it has completed the formation of a joint venture with Lifera, a biopharma company wholly owned by Saudi Arabia's Public Investment Fund (PIF). The deal was originally announced in June. The JV, to be located in Riyadh and named Lifera Omics, aims to increase access to genomic and multiomic testing to patients in Saudi Arabia and countries of the Gulf Cooperation Council.
Under the terms of the agreement, Lifera will own 80 percent and Centogene 20 percent of the JV. According to a filing with the US Securities and Exchange Commission, Centogene also granted the JV an exclusive license to certain know-how, patents, and data in the Kingdom of Saudi Arabia. Centogene is eligible to earn performance-related milestone payments, including a $10 million upfront JV milestone payment and low-single-digit royalties on the JV's net revenues starting on the sixth anniversary of the JV until 2033. Both companies will be represented on the board of Lifera Omics, and two Lifera representatives will join Centogene's supervisory board. As previously reported, Lifera also made a $30 million investment in Centogene in the form of a convertible loan, which will automatically convert into common stock no more than six months from Oct. 26, 2023.
Hologic, investment firm KKR, and Ajax Health said this week that they formed a partnership to acquire, develop, and commercialize medical devices to aid lung cancer diagnosis and treatment. Under the terms of the deal, Hologic and KKR will invest in a platform, dubbed Maverix Medical, that will be managed by Ajax Health. Ajax is also contributing the technologies of its subsidiary Serpex Medical, which develops tools to target lung tissue for biopsy or therapy delivery. Financial and other terms of the deal were not disclosed.
Clinical lab firm Atalan said this week that it has added Albuquerque, New Mexico-based TriCore to its network of clinical labs. Atalan, which was launched in October by Froedtert Health, Wisconsin Diagnostic Laboratories (WDL), and HealthEco, has developed an informatics package that allows multiple laboratories to order tests from one another and track and manage results, with the initial goal of developing a network of clinical laboratories that can leverage each other’s capabilities.
Twinsburg, Ohio-based pharmacogenomic testing firm Xact Laboratories this week said it is partnering with an unnamed national prescription claims clearinghouse to offer a new PGx service to health insurers. With the new offering, PGx test results are automatically integrated into the prescription fulfillment workflow, so that clinicians and pharmacists treating members of participating health plans can be notified if a patient has actionable PGx results that might impact their prescription.
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.