The U.S Food and Drug Administration approved the blood based diagnostic
of cobas EGFR Mutation Test v2 for Tarceva (erlotinib) cancer
drug. It is the first blood test that will be able to detect a gene mutation, a
leading breakthrough in the non-small cell lung cancer market, and a
novel genetic test for detecting epidermal growth receptor gene mutation for
relevant patients.
These mutations are affecting 10 to 20 percent of NSCLC, and a prime
cause for cancer linked death in men more, but increasingly even women are
dying due to related consequences. The
test approved gives positive results, thus is it a great option for people who
are unable to undergo examination of tumor specimen through EGFR testing. The
efficacy of this test has had backing of clinical trials and determined safe.
Blood Sample Testing Helps Patients with NSCLC
NSCLC is among most common lung cancer type, which sheds tumor DNA in the
patient’s blood, thus, making it possible for analyzing specific mutations via
blood samples. Examining the tumor DNA blood is also known as liquid biopsy,
whose approval can deliver individualized health care to people. These biopsies
are potential in identifying patients with tumors specific mutation in most
non-invasive way.
The cobas EGFR
Mutation Test v2 detects NSCLC mutation specific presence in blood samples,
assisting in selecting the ones that has benefits with treatment by
Tarceva. As per the medical market research, about 221,200 Americans may be
diagnosed with lung cancer and the deaths will account for 158,040 people this
year. The exon 21 substitution or exon 12 deletion mutations if not
detected in person’s blood, can b studied via tumor biopsy then.
Tarceva as First-Line Treatment and Facts
FDA had given approval in 2004 for in treating patients with advanced
locally or metastatic NSCLC following failure of a chemotherapy regimen. In
2013, the FDA certified the treatment as first-line in people with metastatic non-small
cell lung cancer, with tumors of EGFR exon 19 deletions by an approved
testing method. The common side effects for the treatment are anorexia, rash,
fatigue, diarrhea, cough, dyspnea, vomiting, and nausea.
Tarceva is not for people who have taken a platinum underlined
chemotherapy. It is not as first-line remedy for patients with NSCLC metastatic
tumprs with EGFR mutations different than L858R
substitution mutations or exon 19 deletions. The manufacturer of cobas EGFR Mutation Test v2 is Roche
Molecular Systems in Pleasanton, California, while Tarceva is a brainchild of
Astellas Pharma Technologies, Inc. of Norman, Oklahoma.
