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In Brief This Week: Becton Dickinson, Proscia, Co-Diagnostics, Biocept, and More

NEW YORK – Becton Dickinson said this week that its board has approved the spinoff of its diabetes care business into a separate company called Embecta. BD also declared a pro rata distribution of all outstanding shares of Embecta's common shares to BD shareholders. The spinoff will occur on April 1 and will allow BD to focus on its core innovation priorities, the Franklin Lakes, New Jersey-based company said. After the spinoff, Embecta will be an independent publicly traded firm, and BD will have no ownership interest in it.

Sophia Genetics said this week that is has extended its 2016 partnership with the Institut Paoli Calmettes, one of 18 Comprehensive Cancer Centers in France, to further support the implementation, automation, and accreditation of cancer tests, including for lung, breast, ovarian, and hematological cancers.

Proscia and Sweden's Uppsala University Hospital announced a multiyear agreement this week to digitize the region's pathology workflows using Proscia's Concentriq Dx digital pathology technology. Financial and other terms of the deal were not disclosed. Proscia CEO David West said in a statement that Uppsala aims to achieve full digitization by 2024.

Co-Diagnostics and its Indian joint venture CoSara Diagnostics said this week that India's Central Drugs Standard Control Organization has cleared the Saraq Hepatitis B Viral Load Kit for manufacturing and sale as an in vitro diagnostic. CoSara's test leverages Co-Diagnostics' CoPrimer technology and is designed to help assess response to antiviral treatments in patients diagnosed with HBV.

Sera Prognostics said this week that it has reached an agreement to participate in preferred provider organization MultiPlan's PHCS and MultiPlan networks, expanding access to the PreTRM proteomic test for measuring a woman's risk of spontaneous preterm birth. More than 700 healthcare payors and 1.2 million providers participate in MultiPlan's networks, Sera said in a statement.

Biocept disclosed in a regulatory document filed with the US Securities and Exchange Commission this week that the company and its accounting firm have determined that its unaudited interim financial statements for the third quarter "can no longer be relied upon." Biocept found that it did not accrue for certain expenses incurred during Q3 totaling about $1 million to $1.2 million. The expenses are mostly for contract labor charges related to the firm's community college COVID-19 testing business. Biocept said that it plans to restate the relevant financial statements soon in its amended Form 10-Q.

Aspira Women's Health said this week that it has reached deals to provide its testing services to Medicaid plan members in New Hampshire and Washington, D.C. New Hampshire covers 200,000 lives under its Medicaid program while D.C. covers 265,000 lives under its program. Aspira said it is now credentialed to provide its OVA1 test to about 80 percent of the Medicaid population, or 60 million lives, in the US.

Bluejay Diagnostics said this week that it has filed a pre-submission package for its Symphony IL-6 test with the US Food and Drug Administration. Based on this, the Acton, Massachusetts-based firm will request feedback from the agency before it submits a medical device application to market the test. Bluejay added that the FDA will now be able to review its clinical trials and analytical testing and provide comments.

On-demand mobile health service firm Sprinter Health said this week that it is collaborating with molecular diagnostics company Naveris to provide a Sprinter nurse or phlebotomist for at-home blood specimen collection for human papillomavirus-related cancer testing. Naveris will offer its NavDx blood test for the detection of circulating tumor tissue-modified HPV DNA. According to Sprinter, the test can detect cancer recurrence a median of four months earlier than a PET or CT scan. Sprinter and Naveris have worked together in California for several months and plan to expand their collaboration to new states in the first half of 2022.

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.