FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market

September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.

But on Sept. 23, less than three weeks later, things turned around when Exact Sciences announced that the FDA had widened its approval for Cologuard to include people age 45 and older, as opposed to the previous approval for people age 50 and older. The clearance, which came a year before the company expected, adds 19 million potential users to Cologuard’s target market. It also greatly improves the prospects for a U.S. Preventive Services Task Force (USPSTF) thumbs-up on mtSDNA colorectal cancer screening. The USPSTF decision is expected by the end of the year.

New FDA Approvals

Here’s a look at all the important new product approvals announced from late September through early October:




Exact Sciences Expanded clearance for Cologuard DNA-based colorectal cancer screening test in average-risk people age 45 and older (as opposed to previous clearance for people age 50 and over)
Cepheid Clearance for Xpert BCR-ABL Ultra test for monitoring disease burden in patients with chronic myeloid leukemia
Luminex 510(k) clearance for real-time PCR-based Aries MRSA Assay running on firm’s Aries sample-to-answer system
Abbott Clearance for Architect Stat highly sensitive troponin blood test for more rapid detection of heart attacks
Bühlmann Laboratories 510(k) clearance for Calex Cap fecal extraction device for use with firm’s fecal calprotectin test
Qiagen Clearance for Therascreen PIK3CA RGQ PCR Kit as companion diagnostic to identify advanced breast cancer patients with PIK3CA mutations likely to respond to Novartis’ Piqray (alpelisib)
Roche Diagnostics Clearance for cobas Babesia whole-blood test for screening blood donations
Roche Diagnostics Clearance for Cobas Pro Integrated Solutions
Roche Diagnostics Clearance for Elecsys Anti-HAV II test to detect total antibodies (IgG and IgM) to hepatitis A virus
 Siemens Healthineers Clearance for Advia Centaur Testosterone II assay to detect total testosterone run on firm’s Advia Centaur XP system
Siemens Healthineers Clearance for the Advia Centaur SHBG immunoassay run on Advia Centaur XP system to measure sex hormone-binding globulin (SHBG) used to diagnose androgen disorders
Axis-Shield Diagnostics Clearance for received clearance for Advia Centaur Erythropoietin assay to diagnose anemias and polycythemias run on Siemens Advia Centaur XP system
Grifols Clearance for QNext fully automated random-access instrument to perform hemostasis testing by detecting changes in optical density
Fujirebio Diagnostics Clearance for Lumipulse G Whole PTH chemiluminescent enzyme immunoassay to measure parathyroid hormone levels during differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism
Check-Points Clearance for BD Max Check-Points CPO Assay run on Becton Dickinson BD Max System
Healstone Biotech Clearance for Accurate Multi Panel Drug Urine Test Cup lateral flow immunochromatographic assay for detecting a combination of two to 15 drugs of abuse
Laboratory for Advanced Medicine Breakthrough device designation for liquid biopsy blood test to detect liver cancer at Stage I
Prescient Metabiomics Breakthrough device designation for LifeKit Prevent Colorectal Neoplasia Test for non-invasive detection of precancerous polyps and early-stage carcinomas

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