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In Brief This Week: Hologic, Chembio Diagnostics, uBiome, and More

NEW YORK – Hologic announced this week that it has completed the previously announced divestiture of its Cynosure medical aesthetics business to an affiliate of investment funds managed by Clayton, Dubilier & Rice for a total purchase price of $205 million in cash, subject to certain closing adjustments. Hologic said that net of these adjustments, it received cash proceeds at closing of approximately $142 million. The firm added that the purchase price remains subject to adjustment upon finalization, pursuant to the terms of the purchase and sale agreement.

Chembio Diagnostics said this week that it anticipates obtaining premarket approval from the US Food and Drug Administration during the first quarter of 2020 for its DPP HIV-Syphilis System.

Chembio’s DPP HIV-Syphilis System is a single-use, 15-minute screening test for the simultaneous detection of antibodies to HIV types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. The system includes the DPP HIV-Syphilis test and DPP Micro Reader. 

The Psomagen-Macrogen Consortium said this week that it has completed the acquisition of all key assets of uBiome, a San Francisco-based microbiomics company that declared bankruptcy earlier this year. The acquisition includes a microbiome patent portfolio comprising 246 patents, anonymized microbiome data, nearly 300,000 samples, and laboratory equipment. The acquisition price is $7.05 million, slightly short of the $7.7 million that was reported by several media outlets in mid-December. The acquisition price represents approximately 1 percent of uBiome's estimated corporate value, the consortium said. The Psomagen-Macrogen Consortium comprises Korean precision medicine firm Macrogen and its US-based clinical diagnostics and direct-to-consumer genomics firm Psomagen. 

Agendia said this week that a German public health insurance fund, Techniker Krankenkasse, will start reimbursing gene expression-based tests for breast cancer patients. Under the fund's contract with the German Pathologists Organization, it will pay for diagnostic tests with the CE mark, including Agendia's MammaPrint test. Agendia said a decision about reimbursement of MammaPrint by all public health insurance funds in Germany is still pending and expected for early 2020.

The Centers for Medicare and Medicaid Services this week officially delayed for one year the gathering of laboratory payment data under the Protecting Access to Medicare Act. On Thursday, the agency announced that data reporting for clinical diagnostic laboratory tests that are not advanced diagnostic lab tests will be reported between Jan. 1, 2021 and March 31, 2021. Originally, the data was supposed to be reported between Jan. 1, 2020 and March 31, 2020. The delay comes as a result of passage of the Lab Act just before Christmas. PiperJaffray analyst William Quirk said in a research note that while the data collection would originally have provided a "small positive update" in reimbursements to labs in 2021, the delay will impact 2022 pricing, instead, as reimbursements in 2021 under PAMA will be based on the original PAMA schedule from data collected during the 2017 period and not the 2020 reporting period. He added the delay is "incrementally negative" for Laboratory Corporation of America and Quest Diagnostics.

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.