Exact Sciences' Stool-DNA-Based Colorectal Cancer Screening Test Likely To Get Favorable Review On Its PMA

Summary

  • Exact Sciences (EXAS) is a molecular diagnostics company focused on colorectal cancer.
  • On March 27, 2014, the Molecular and Clinical Genetics Panel will review the premarket approval application (PMA) for the company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test.
  • After carefully reviewing the published scientific evidence, we believe that Cologuard will receive favorable review on its PMA.

Exact Sciences (NASDAQ:EXAS) is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. On March 27, 2014, the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration will review the premarket approval application (PMA) for the company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test. After carefully reviewing the published scientific evidence, we believe that Cologuard will receive favorable review on its PMA.

Over 600,000 people die from colorectal cancer (CRC) annually worldwide [1]. It is the second leading cause of cancer deaths in the US [2]. According to the Journal of the National Cancer Institute, CRC is often considered the most preventable, yet least prevented cancer. Nearly 50 percent of those age 50 and older have not been screened as recommended. Over 75% of CRC occurs in people with no genetic risks. Most common risk factors include increasing age and unhealthy lifestyle choices [3]. People with inflammatory bowel disease or family history of genetic syndromes such as familial adenomatous polyposis are at higher risk of CRC [3]. Most deaths due to CRC are associated with metastatic disease. CRC confined in the colon is curable by physical removal of the cancer. Standard screening methods are invasive colonoscopy and sigmoidoscopy, which involve a lighted flexible tube passed through the anus, providing a visual diagnosis and opportunity for biopsy. Fecal occult blood test (FOBT) is a non-invasive test, which checks for hidden blood in fecal material by detecting hemoglobin protein stool samples [4].

Cologuard assays exfoliated DNA markers (methylated BMP3 and NDRG4, mutant KRAS, beta-actin) and fecal hemoglobin to detect CRC and its precursors, advanced adenoma (AA) and sessile serrated adenoma (SSA) [5]. In the company's early trial, using 385 cases (133 AA + 252 CRC) and 293 controls collected from 5

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Beacon VP is a multidisciplinary team of Harvard/MIT scientists who are passionate about transforming scientific insights into actionable investment ideas.Beacon VP invests in the scientific foundation of biotech firms, with a focus on drugs and devices progressing through the FDA review process. Our philosophy is: "The business value of small to mid-cap life science companies depends on the underlying science of its drugs. We assess its safety and efficacy, then buy low and sell high".

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