Industry roundup: Oncology dominates noncoronavirus IVD news

2019 08 08 22 40 7691 Carlson Bruce Aacc 2019 400

While COVID-19 now dominates the clinical diagnostics industry, there has been a growing number of IVD product launches in unrelated test areas, from blood cancers to Legionnaires' disease to bee sting allergies.

There's no doubt that COVID-19 tests remain a focal point for research and development -- IVD manufacturers have released scores of COVID-19 tests in the U.S. and Europe, as the decline in elective procedures dragged down demand for traditional diagnostics. But companies increasingly are announcing new non-COVID-19 innovations designed to help them stay competitive for when reopening occurs. We have also seen some merger activity, though reduced from the prepandemic days.

Cancer dominated these recent non-COVID announcements:

  • Qiagen's therascreen BRAF V600E kit, a polymerase chain reaction (PCR) assay, has been cleared by the U.S. Food and Drug Administration (FDA) as a companion diagnostic to Pfizer's targeted drug encorafinib (Braftovi) in metastatic colorectal cancer. The test will help identify which patients are eligible for treatment with Braftovi, which is a BRAF inhibitor approved for use in combination with Lilly's cetuximab (Erbitux) in adults with previously treated metastatic colorectal cancer and who have a BRAF V600E mutation. Qiagen noted that in patients with primary and metastatic colorectal cancer, BRAF mutations (nearly always V600E) are found in up to 15% of patients; they are thought to be key drivers of tumor growth.
  • Roche's HPV test has been cleared by the FDA for use on the fully automated, high-throughput cobas 6800/8800 systems. The test was previously cleared for the cobas 4800 model, and the new approvals allow for much greater throughput. Roche also received FDA clearance for its Elecsys Brahms procalcitonin (PCT) electrochemiluminescence immunoassay, as well as for its Tina-quant hemoglobin A1c (HbA1c) Gen.3 assay for the diagnosis of diabetes and identification of patients at risk of developing diabetes.

Furthermore, Roche announced that the tissue diagnostics segment of its diagnostic division had an impressive first quarter despite the pandemic. The division is focused on cancer, companion testing, and inherited diseases. The company reported that revenues were not impacted by SARS-CoV-2. Tissue diagnostics revenues grew 8%. Advanced staining sales were up by 11%, primary staining sales grew 3%, and companion diagnostics sales increased by 30%.

  • Bio-Rad acquired Ann Arbor, MI-based Celsee, a company that offers instruments and consumables for the isolation, detection, and analysis of single cells.
  • Quest Diagnostics-owned Blueprint Genetics and North American Immuno-Hematology Clinical Education & Research (NICER) announced that they are teaming up to develop a genetic test for immunologic and hematologic disorders. Their comprehensive immune and cytopenia 600-gene panel test, which is performed on a whole exome sequencing backbone, will support the creation of a patient registry and innovative research in the field, according to the companies.
  • Hologic received FDA clearance for the Aptima Combo 2 assay for Trichomonas vaginalis, a sexually transmitted infection (STI), for use on its Panther system.
  • Thermo Fisher Scientific's ImmunoCap Specific Immunoglobulin E (IgE) Stinging Insect Allergen Components blood test was just cleared in the U.S. The test was designed to analyze a patient's sensitivity to up to eight different proteins found in bee and wasp venom that may cause anaphylaxis and other allergic symptoms.
  • Denmark-based SSI Diagnostica received FDA clearance for its ImmuView antigen test for Legionella pneumophila, a bacterium known to cause Legionnaires' disease.
  • Grail launched a large prospective interventional study of its multicancer blood test. The study -- called Pathfinder -- will look for cancer signals and help assess tissue origin in 6,200 participants.
  • Thrive Earlier Detection released data for its investigational multicancer test in the 10,000-patient Detecting Cancers Earlier Through Elective Mutation-based Blood Collection and Testing (DETECT-A) study at the American Association for Cancer Research (AACR) virtual meeting in April. The test showed promise for increasing the number of screen-detected cancers beyond the standard of care, and a registrational study is in the planning stages.
  • ArcherDX and Premier are collaborating on a genomic sequencing assay for cancers. The firms will compare Stratafide, a pansolid tumor diagnostic test that identifies actionable genomic alterations in tissue or blood samples, with other diagnostic tests in a retrospective study.

There was also an important change unrelated to COVID-19 on the regulatory front of late. In April, the FDA finalized guidance related to the development and labeling of companion diagnostics in oncology. The guidance smooths the way for developers of oncologic companion diagnostics to develop and pursue approval of an assay for guiding the use of a group of similar drugs rather than a specific named drug.

Previous guidance made this pathway possible, but it was confusing for test vendors, and in practice most FDA approvals of companion tests had labeling referencing a specific drug. The FDA now says a test can qualify in the context of a therapeutic group of drugs that have the same indication, "including the same molecular alteration(s), such as mutation(s), amplification(s), and fusion(s)." Vendors still have to show evidence that their companion test will work with multiple therapies.

Non-COVID-19 diagnostic product launches and developments could be taken as a good sign for the future market by test vendors, particularly in oncology testing, which is a very important sector for revenue lines of major IVD firms.

Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group.

Disclosure: LabPulse.com is a sister company of Kalorama Information.

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