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In Brief This Week: Roche, GenMark, Ortho Clinical Diagnostics, Thermo Fisher Scientific, and More

NEW YORK – Roche announced this week that it has begun a cash tender offer for all of GenMark Diagnostics’ outstanding shares of common stock at $24.05 per share. The offer is being made after the company announced earlier this month that it plans to acquire GenMark. The offer period will expire April 21 unless it is extended. GenMark’s board of directors unanimously recommended that stockholders tender their shares in the offer. Any shares not acquired in the offer will be acquired in a second step merger, Roche said. The deal is expected to close in the second quarter.


Ortho Clinical Diagnostics said this week that it has received authorization from the US Food and Drug Administration to update key claims for its Vitros SARS-CoV-2 Antigen Test.

The updated claims are related to improved sensitivity data, updated specimen collection methods, and additional viral transport media. Ortho said that its Vitros SARS-CoV-2 Antigen Test, which was granted FDA Emergency Use Authorization in January, demonstrates 94.8 percent sensitivity for samples with a PCR cycle threshold of less than 30. Studies have shown that samples with PCR CT values of 30 to 33, or greater, carry little to no live virus, suggesting these patients may no longer be infectious, the firm added. Personnel in hospitals, reference labs, and other healthcare settings will now be able to use a nasal sample, which is more convenient than the nasopharyngeal swab specimen collection method, and testing leaders will be able to utilize three additional viral transport media options.


Thermo Fisher Scientific said this week that it has completed listing its Applied Biosystems QuantStudio 5 Dx Real-Time PCR system with the US Food and Drug Administration. The system already has the CE-IVD mark and has been certified and approved by China's National Medical Products Administration.


In its 10-K form filed with the US Securities and Exchange Commission last week, Progenity disclosed that diagnostic firm Ravgen sued it for patent infringement in December. Ravgen claimed in its suit that Progenity’s Innatal Prenatal Screen and Resura non-invasive prenatal tests infringe on Ravgen’s patents 7,727,720 and 7,332,277 for methods of detection of genetic disorders. These methods involve increasing the percentage of cell-free fetal DNA in a maternal blood sample to create a non-invasive test. The suit claims Progenity knew about the patents and continued to commercialize its tests without licensing Ravgen’s technology or paying for its use. The deadline for Progenity to respond to the suit was March 23.


Inspirata this week announced a multiyear extension of its partnership with Ohio State University Comprehensive Cancer Center's Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. The partnership was initiated in 2016 and has resulted in more than 1.75 million whole-slide images being scanned and the first primary diagnosis sign-out through digital in the US, according to the Tampa, Florida-based digital pathology firm.


Natera said this week that the US Food and Drug Administration has granted it two Breakthrough Device Designations covering new intended uses of its Signatera molecular residual disease test. The new Breakthrough Device Designations, which support the development of Signatera through Phase III clinical trials as a companion diagnostic to two unnamed cancer therapies, add to another such designation for Signatera that Natera received in 2019.


Molecular diagnostics firm PreludeDx said this week that it has entered into an agreement with MultiPlan to participate in the healthcare cost management company's primary and complementary networks. Under the terms of the agreement, more than 60 million members and nearly 1 million providers will obtain access at discounted rates to the PreludeDx genomic test DCISionRT. Financial and other terms of the agreement were not disclosed.

DCISionRT predicts recurrence risk and radiation therapy benefits for patients with ductal carcinoma in situ (DCIS), an early form of breast cancer confined to the milk ducts.


Caris Life Sciences said this week that the Cancer Center at California Pacific Medical Center (CPMC) has joined Caris’ Precision Oncology Alliance, a collaborative network of cancer centers working to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through research on predictive and prognostic markers that improve clinical outcomes.

The alliance now includes 49 cancer centers and academic institutions, Caris said. These institutions have early access to the company’s database and artificial intelligence platform to establish evidence-based standards for cancer profiling and molecular testing in oncology, as well to the Caris CODEai data solution, which contains cancer treatment information and clinical outcomes data for more than 244,000 patients.


Exagen announced this week that it has closed its public offering of 4,255,000 shares of its common stock, including 555,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, at a price of $16.25 per share. Gross proceeds from the offering were approximately $69.1 million.

The company said it plans to use the proceeds to develop multiomics capabilities, advance its product pipeline, enhance its intellectual property protection, and for working capital and other general corporate purposes. Cowen, William Blair, and Cantor Fitzgerald were joint bookrunning managers for the offering, with BTIG acting as lead manager.


Myriad Genetics said this week that its myChoice Diagnostic System will be reimbursed in Japan when it is used to determine which advanced ovarian cancer patients have homologous recombination repair deficiency and may benefit from first-line maintenance treatment with olaparib (AstraZeneca's Lynparza). In November, Japan’s Ministry of Health, Labor, and Welfare approved myChoice as a companion diagnostic for olaparib in this setting. The test is also approved and reimbursed in Japan as a companion test to identify ovarian cancer patients who are likely to benefit from niraparib (GlaxoSmithKline's Zejula). Myriad has a deal with SRL, a subsidiary of HU Group Holdings, to commercialize myChoice in Japan.


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.