cobas® MAI Positive Control Kit - India CDSCO Medical Device Registration

Product Information

cobas® MAI Positive Control Kit is to be used in conjunction with the cobas® MAI Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® MTB-RIF/INH(cobas® MAI Positive Control Kit)-cobas® MTB-RIF/INH for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection of rifampicin-resistance associated mutations of the rpoB gene, and isoniazid-resistance associated mutations in the katG and inhA genes, of Mycobacterium tuberculosis, from human respiratory specimens. The test is intended for use on either acid-fast bacilli (cobas® MAI Positive Control Kit) smear-positive or smear-negative, raw sputum, and digested and decontaminated (cobas® MAI Positive Control Kit) sputum and bronchial alveolar lavage (cobas® MAI Positive Control Kit) samples, that tested positive for Mycobacterium tuberculosis complex (cobas® MAI Positive Control Kit) by cobas® MTB. This test is intended for use in conjunction with culture and drug susceptibility testing, and as a reflex test together with cobas® MTB, as an aid in the diagnosis of infection with a multidrug resistant M. tuberculosis (cobas® MAI Positive Control Kit).,cobas® MTB-RIF/INH Positive Control Kit(cobas® MAI Positive Control Kit)-cobas® MTB-RIF/INH Positive Control Kit is to be used in conjunction with cobas® MTB-RIF/INH Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® DPX(cobas® MAI Positive Control Kit)-The cobas DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (cobas® MAI Positive Control Kit) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.,cobas® DPX Control Kit(cobas® MAI Positive Control Kit)-"The cobas® DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (cobas® MAI Positive Control Kit) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.",cobas® HEV - 96(cobas® MAI Positive Control Kit)-"The cobas® HEV test for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (cobas® MAI Positive Control Kit) RNA (cobas® MAI Positive Control Kit) in human plasma. This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (cobas® MAI Positive Control Kit), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for HEV." ,cobas® HEV Control Kit(cobas® MAI Positive Control Kit)-cobas® HEV Control Kit will be used with the main kits cobas® HEV - 96 ,cobas® WNV - 96(cobas® MAI Positive Control Kit)-"cobas® WNV for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of West Nile virus (cobas® MAI Positive Control Kit) RNA in human plasma. This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating or from cadaveric (cobas® MAI Positive Control Kit) donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or in pools comprised of not more than six individual samples. For all other donors, samples may only be screened as individual samples. This test is not intended for use as an aid in diagnosis of WNV infection. This test is not intended for use on samples of cord blood." ,cobas® WNV Control Kit(cobas® MAI Positive Control Kit)-cobas® WNV Control Kit will be used with the main kits cobas WNV test ,cobas® EGFR Mutation Test v2(cobas® MAI Positive Control Kit)-"The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (cobas® MAI Positive Control Kit) gene in non-small cell lung cancer (cobas® MAI Positive Control Kit) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (cobas® MAI Positive Control Kit) or circulating-free tumor DNA (cobas® MAI Positive Control Kit) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with EGFR tyrosine kinase inhibitors (cobas® MAI Positive Control Kit) in accordance with the approved therapeutic product labeling: Table 1: Drug: TARCEVA® (cobas® MAI Positive Control Kit) FFPET Exon 19 deletions and L858R Plasma Exon 19 deletions and L858R. Drug:TAGRISSO® (cobas® MAI Positive Control Kit): FFPET Exon 19 deletions, L858R and T790M Plasma:Exon 19 deletions, L858R and T790M. Drug:IRESSA® (cobas® MAI Positive Control Kit) FFPET Exon 19 deletions and L858R Plasma Exon 19 deletions and L858R Testing of plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained. Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine tissue biopsy and testing for EGFR mutations with the FFPET sample type, if available. Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2: TARCEVA® (cobas® MAI Positive Control Kit):G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861Q TAGRISSO® (cobas® MAI Positive Control Kit) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 20 insertions, S768I, and L861Q IRESSA® (cobas® MAI Positive Control Kit) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861Q The cobas® EGFR Mutation Test v2 for use with plasma includes a semi-quantitative measurement of mutations in exons 18, 19, 20, and 21 of the EGFR gene. This measurement, reported as a semi-quantitative index (cobas® MAI Positive Control Kit), correlates to the amount of target mutant cfDNA in plasma and can be used to determine changes in target mutant cfDNA load over time for a given patient. For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection" ,cobas® 4800 BRAF V600 Mutation Test(cobas® MAI Positive Control Kit)-The primary use of the cobas® 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (cobas® MAI Positive Control Kit) tissue. In melanoma, it is intended to be used as an aid in selecting patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (cobas® MAI Positive Control Kit).,cobas® KRAS Mutation Test(cobas® MAI Positive Control Kit)-"The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of somatic mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (cobas® MAI Positive Control Kit) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cobas® MAI Positive Control Kit) or with Vectibix® (cobas® MAI Positive Control Kit) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cobas® MAI Positive Control Kit) or Vectibix® (cobas® MAI Positive Control Kit) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.",cobas® PIK3CA Mutation Test(cobas® MAI Positive Control Kit)-The cobas® PIK3CA Mutation Test is a real-time PCR test for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10 and 21 in the gene encoding the catalytic subunit of phosphoinositide 3-kinase (cobas® MAI Positive Control Kit) in DNA isolated from formalin-fixed paraffin-embedded tumor tissue (cobas® MAI Positive Control Kit). The cobas® PIK3CA Mutation Test is a real-time PCR test for use on the cobas® 4800 System intended to be used to identify patients with metastatic breast cancer whose tumors harbor these mutations.,cobas® MTB(cobas® MAI Positive Control Kit)-cobas® MTB for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection of Mycobacterium tuberculosis complex (cobas® MAI Positive Control Kit) DNA in either acid-fast bacilli (cobas® MAI Positive Control Kit) smear-positive or smear-negative, human respiratory specimens; including raw sputum, and digested and decontaminated (cobas® MAI Positive Control Kit) sputum and bronchoalveolar lavage (cobas® MAI Positive Control Kit) samples. This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended for the aid of pulmonary tuberculosis diagnosis, and in conjunction with culture and other laboratory findings, as well as clinical signs and symptoms.,cobas® MTB Positive Control Kit(cobas® MAI Positive Control Kit)-cobas® MTB Positive Control Kit is to be used in conjunction with the cobas® MTB test on cobas 6800 and cobas 8800 system,cobas® MAI(cobas® MAI Positive Control Kit)-cobas® MAI for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in human respiratory specimens including inactivated raw sputum, and inactivated digested and decontaminated (cobas® MAI Positive Control Kit) sputum inactivated, digested and decontaminated (cobas® MAI Positive Control Kit) bronchoalveolar lavage (cobas® MAI Positive Control Kit) samples. This test is intended for use in conjunction with culture as an aid in the diagnosis of M. avium-intracellulare complex (cobas® MAI Positive Control Kit) infection.,cobas® MTB(cobas® MAI Positive Control Kit)-cobas® MTB for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection of Mycobacterium tuberculosis complex (cobas® MAI Positive Control Kit) DNA in either acid-fast bacilli (cobas® MAI Positive Control Kit) smear-positive or smear-negative, human respiratory specimens; including raw sputum, and digested and decontaminated (cobas® MAI Positive Control Kit) sputum and bronchoalveolar lavage (cobas® MAI Positive Control Kit) samples. This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended for the aid of pulmonary tuberculosis diagnosis, and in conjunction with culture and other laboratory findings, as well as clinical signs and symptoms.,cobas® CMV(cobas® MAI Positive Control Kit)-cobas® CMV is an in-vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (cobas® MAI Positive Control Kit) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.,cobas® EGFR Mutation Test v2(cobas® MAI Positive Control Kit)-"The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (cobas® MAI Positive Control Kit) gene in non-small cell lung cancer (cobas® MAI Positive Control Kit) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (cobas® MAI Positive Control Kit) or circulating-free tumor DNA (cobas® MAI Positive Control Kit) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with EGFR tyrosine kinase inhibitors (cobas® MAI Positive Control Kit) in accordance with the approved therapeutic product labeling: Table 1: Drug: TARCEVA® (cobas® MAI Positive Control Kit) FFPET Exon 19 deletions and L858R Plasma Exon 19 deletions and L858R. Drug:TAGRISSO® (cobas® MAI Positive Control Kit): FFPET Exon 19 deletions, L858R and T790M Plasma:Exon 19 deletions, L858R and T790M. Drug:IRESSA® (cobas® MAI Positive Control Kit) FFPET Exon 19 deletions and L858R Plasma Exon 19 deletions and L858R Testing of plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained. Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine tissue biopsy and testing for EGFR mutations with the FFPET sample type, if available. Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2: TARCEVA® (cobas® MAI Positive Control Kit):G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861Q TAGRISSO® (cobas® MAI Positive Control Kit) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 20 insertions, S768I, and L861Q IRESSA® (cobas® MAI Positive Control Kit) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861Q The cobas® EGFR Mutation Test v2 for use with plasma includes a semi-quantitative measurement of mutations in exons 18, 19, 20, and 21 of the EGFR gene. This measurement, reported as a semi-quantitative index (cobas® MAI Positive Control Kit), correlates to the amount of target mutant cfDNA in plasma and can be used to determine changes in target mutant cfDNA load over time for a given patient. For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection" ,cobas® 4800 BRAF V600 Mutation Test(cobas® MAI Positive Control Kit)-The primary use of the cobas® 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (cobas® MAI Positive Control Kit) tissue. In melanoma, it is intended to be used as an aid in selecting patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (cobas® MAI Positive Control Kit).,cobas® KRAS Mutation Test(cobas® MAI Positive Control Kit)-"The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of somatic mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (cobas® MAI Positive Control Kit) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cobas® MAI Positive Control Kit) or with Vectibix® (cobas® MAI Positive Control Kit) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cobas® MAI Positive Control Kit) or Vectibix® (cobas® MAI Positive Control Kit) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.",cobas® CMV - 96(cobas® MAI Positive Control Kit)-"cobas® CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (cobas® MAI Positive Control Kit) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings." ,cobas® CMV Control Kit(cobas® MAI Positive Control Kit)-The cobas® CMV Control Kit is to be used in conjunction with the cobas® CMV Quantitative nucleic acid test for use on the cobas® 6800/8800 Systems cobas® CMV Quantitative nucleic acid test for use on the cobas® 4800 System ,cobas® DPX(cobas® MAI Positive Control Kit)-The cobas DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (cobas® MAI Positive Control Kit) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.,cobas® DPX Control Kit(cobas® MAI Positive Control Kit)-"The cobas® DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (cobas® MAI Positive Control Kit) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.",cobas® HEV - 96(cobas® MAI Positive Control Kit)-"The cobas® HEV test for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (cobas® MAI Positive Control Kit) RNA (cobas® MAI Positive Control Kit) in human plasma. This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (cobas® MAI Positive Control Kit), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for HEV." ,cobas® HEV Control Kit(cobas® MAI Positive Control Kit)-cobas® HEV Control Kit will be used with the main kits cobas® HEV - 96 ,cobas® WNV - 96(cobas® MAI Positive Control Kit)-"cobas® WNV for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of West Nile virus (cobas® MAI Positive Control Kit) RNA in human plasma. This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating or from cadaveric (cobas® MAI Positive Control Kit) donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or in pools comprised of not more than six individual samples. For all other donors, samples may only be screened as individual samples. This test is not intended for use as an aid in diagnosis of WNV infection. This test is not intended for use on samples of cord blood." ,cobas® WNV Control Kit(cobas® MAI Positive Control Kit)-cobas® WNV Control Kit will be used with the main kits cobas WNV test ,cobas® MTB Positive Control Kit(cobas® MAI Positive Control Kit)-cobas® MTB Positive Control Kit is to be used in conjunction with the cobas® MTB test on cobas 6800 and cobas 8800 system,cobas® MAI(cobas® MAI Positive Control Kit)-cobas® MAI for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in human respiratory specimens including inactivated raw sputum, and inactivated digested and decontaminated (cobas® MAI Positive Control Kit) sputum inactivated, digested and decontaminated (cobas® MAI Positive Control Kit) bronchoalveolar lavage (cobas® MAI Positive Control Kit) samples. This test is intended for use in conjunction with culture as an aid in the diagnosis of M. avium-intracellulare complex (cobas® MAI Positive Control Kit) infection.,cobas® MAI Positive Control Kit(cobas® MAI Positive Control Kit)-cobas® MAI Positive Control Kit is to be used in conjunction with the cobas® MAI Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® MTB-RIF/INH(cobas® MAI Positive Control Kit)-cobas® MTB-RIF/INH for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (cobas® MAI Positive Control Kit), for the direct detection of rifampicin-resistance associated mutations of the rpoB gene, and isoniazid-resistance associated mutations in the katG and inhA genes, of Mycobacterium tuberculosis, from human respiratory specimens. The test is intended for use on either acid-fast bacilli (cobas® MAI Positive Control Kit) smear-positive or smear-negative, raw sputum, and digested and decontaminated (cobas® MAI Positive Control Kit) sputum and bronchial alveolar lavage (cobas® MAI Positive Control Kit) samples, that tested positive for Mycobacterium tuberculosis complex (cobas® MAI Positive Control Kit) by cobas® MTB. This test is intended for use in conjunction with culture and drug susceptibility testing, and as a reflex test together with cobas® MTB, as an aid in the diagnosis of infection with a multidrug resistant M. tuberculosis (cobas® MAI Positive Control Kit).,cobas® MTB-RIF/INH Positive Control Kit(cobas® MAI Positive Control Kit)-cobas® MTB-RIF/INH Positive Control Kit is to be used in conjunction with cobas® MTB-RIF/INH Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® PIK3CA Mutation Test(cobas® MAI Positive Control Kit)-The cobas® PIK3CA Mutation Test is a real-time PCR test for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10 and 21 in the gene encoding the catalytic subunit of phosphoinositide 3-kinase (cobas® MAI Positive Control Kit) in DNA isolated from formalin-fixed paraffin-embedded tumor tissue (cobas® MAI Positive Control Kit). The cobas® PIK3CA Mutation Test is a real-time PCR test for use on the cobas® 4800 System intended to be used to identify patients with metastatic breast cancer whose tumors harbor these mutations.