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In Brief This Week: Roche, Progenity, NanoString Technologies, 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.

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 two of Ravgen's patents for methods of detection of genetic disorders, patents 7,727,720 and 7,332,277. 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.

NanoString Technologies said this week that it will begin offering GeoMx Digital Spatial Profiler technology access program grants to at least one startup in each Illumina Accelerator funding cycle.

The first startup to receive a grant is Doloromics, a Dallas-based startup working on therapeutics for chronic pain. Doloromics will use its GeoMx grant to spatially characterize the dorsal root ganglion with NanoString's Whole Transcriptome Atlas. Financial and other details of the grant were not disclosed.

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 BDDs, which support the development of Signatera through Phase III clinical trials as a companion diagnostic to two unnamed cancer therapies, add to another BDD for Signatera that Natera received in 2019.

Akoya Biosciences said this week that it will offer its CODEX single-cell, whole-tissue imaging technology to members of the Human Cell Atlas consortium under what it called "favorable commercial terms."

The CODEX platform generates high-resolution maps of millions of cells from each tissue section, enabling comprehensive spatial phenotyping, which complements single-cell RNA-seq-driven cell phenotyping, the company said. This will help provide unbiased, whole-tissue, and single-cell imaging that will contribute towards building a cell atlas to advance the mission of the HCA program, Akoya added.

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 $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 multi-omic 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 acted as 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.

Twist Bioscience announced this week it has entered a partnership with Kyowa Kirin Pharmaceutical Research to discover novel antibodies for therapeutic use against an undisclosed G protein-coupled receptor target molecule.

Under the terms of the agreement, Twist's biopharma division will apply the firm's DNA synthesis platform to design and manufacture proprietary antibodies for Kyowa Kirin. Twist received an upfront payment and Kyowa Kirin retains an option to obtain development and commercial rights to any antibodies resulting from the partnership.

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 have 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. MultiPlan's clients, their members, and network providers will have access to DCISionRT, which determines whether surgery alone or surgery coupled with radiation therapy is appropriate for DCIS, PreludeDx said.

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.

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 EUA in January, demonstrates 94.8 percent sensitivity for samples with a PCR cycle threshold — which is an assessment of viral load — 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 now be able to utilize three additional viral transport media options, Ortho said.

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.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.