Hologic (HOLX) ThinPrep Genesis Processor Gets FDA Approval

Hologic, Inc. HOLX recently announced the receipt of FDA premarket approval (PMA) of ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications. Notably, the ThinPrep Genesis processor is the newest addition to Hologic’s suite of cytology instruments offering simple, multipurpose and scalable solutions for laboratories of all sizes.

Per Hologic’s management, the launch of the ThinPrep Genesis processor is toward the continued commitment to improve the testing experience for laboratory partners, and helping them and clinicians deliver accurate results for women.

The latest approval will boost Hologic’s diagnostics solutions offering.

More in the News

The ThinPrep portfolio was first launched with the first liquid-based Pap test transformed and increased the precision of cervical cancer screening. The product line later included the ThinPrep Imaging System. The newest addition of automated, assisted imaging can increase the sensitivity of detecting suspicious cells compared to manual slide review as validated by the independent studies.

ThinPrep Genesis processor provides new automation capabilities and workflow enhancements with features like automated tube and slide labeling, barcode scanning, vial uncapping/capping and sample aliquoting.

The instrument simplifies workflows with advanced automation capabilities, including chain of custody verification, which prevents sample misidentification and allows for accuracy in results.

Industry Prospects

Per a report by Grand View Research, the global histology and cytology market size is expected to reach $37.7 billion by 2028, at a CAGR of 13.1%. Increasing incidence of cancer, development of advanced tools for early disease diagnosis and innovation in microscopy are driving the market.

Notable Developments

In May 2021, Hologic launched Project Health Equality (PHE) – an initiative that committed to address the structural and cultural barriers that prevent Black and Hispanic women in the United States from receiving the same quality health care as white women. PHE will initially focus on how health care is experienced by thousands of Black and Hispanic women in the United States.

In the same month, Hologic subsidiary, Biotheranostics, Inc., received broader Medicare coverage for its Breast Cancer Index test under an expanded Medicare Local Coverage Determination. Under the new criteria, the Breast Cancer Index  test is now covered for post-menopausal women diagnosed with early-stage node-positive (one to three axillary lymph nodes), non-relapsed, estrogen receptor (ER) and/or progesterone receptor (PR) positive, HER2 negative breast cancer to help physicians manage treatment of the patient.

Recent Developments by Peers in Women Health Offerings

Hologic is facing tough competition from companies like Becton, Dickinson and Company BDX or BD, Myriad Genetics, Inc. MYGN and Exact Sciences Corporation EXAS.

In May 2021, BD announced the industry-first CE marked assay for HPV screening from at-home self-collected vaginal samples. Per BD management, not only does self-collection allow women with greater access to testing but they may also feel confident that the reliability of HPV testing of self-collected samples is the same as if they went to a clinician.

In March 2021, Myriad Genetics announced the receipt of additional reimbursement in Japan for its myChoice Diagnostic System. Notably, the test aids in identifying patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib). This reimbursement for use in first-line treatment is in addition to the existing reimbursement for the fourth-line treatment of ovarian cancer.

In December 2020, Exact Sciences’ RxPONDER study results showed that the Oncotype Dx test can now spare chemotherapy use in majority of women with node-positive early-stage breast cancer. During the study, no chemotherapy benefit was observed regardless of the number of affected nodes, tumor grade, or size. Two-thirds of the women in the trial were postmenopausal.

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