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In Brief This Week: Aspira Women's Health, Sprinter Health, Naveris, Sophia Genetics, Theseus, Syros

NEW YORK – 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.

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.

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.

Theseus Pharmaceuticals said this week that the US Food and Drug Administration has granted orphan drug designation to its lead therapeutic candidate THE-630 for treating advanced gastrointestinal stromal tumors. The Cambridge, Massachusetts-based firm is developing the pan-variant KIT inhibitor for advanced GIST patients who have become resistant to earlier kinase inhibitor treatments through the emergence of KIT mutations and began a Phase I/II trial in this setting in January. The FDA grants orphan drug designation to treatments for rare diseases. The designation gives drug sponsors assistance with drug development, tax credits for clinical trial costs, exemption from certain regulatory fees, and seven years of marketing exclusivity.

Syros Pharmaceuticals said this week that the US Food and Drug Administration has granted orphan drug designation to its selective retinoic acid receptor alpha agonist tamibarotene for treating newly diagnosed, higher-risk myelodysplastic syndrome patients who are RARA positive. The Cambridge, Massachusetts-based firm is studying the activity of the drug with azacitidine in this patient subgroup in the Phase III SELECT-MDS-1 trial, which is expected to read out between Q4 2023 and Q1 2024. The firm hopes to file for regulatory approval sometime in 2024.

Syros is also studying tamibarotene with azacitidine and Genentech/AbbVie's Venclexta (venetoclax) in newly diagnosed, unfit acute myeloid leukemia patients who are RARA positive. This treatment also has orphan drug designation in this setting. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.