CLIA Application from MOTIONS IN LIMINE
Hello Anvil, here's what was said in the recent In Limne rulings:
According to the Government, the evidence at trial will show that in or around November2016, Arrayit was notified by CDPH that it had received complaints that Arrayit was engaging inallergy testing without possessing a state license from CDPH or a CLIA certification. CPDH discovered that Defendant had made false and fraudulent statements that it was CLIA certified when it was not. After this investigation, CDPH denied Arrayit’s application for a state license. CDPH informed Arrayit that one of the reasons for the denial was that Arrayit failed to satisfy numerous requirements regarding the roles and responsibilities for the role of a laboratory director. Ultimately, Arrayit was able to obtain a CLIA COR. See Govt. Opp. No. 4 at 4. The SI alleges that Defendant obtained this certification by making numerous false statements regarding the roles and responsibilities of Dr. Taguchi and others at the laboratory and concealed his true role. SI ¶¶ 38, 39. However, Arrayit still had to obtain proof of accreditation by CAP. According to the Government, the evidence at trial will show that Defendant was unable to satisfy the requisite requirements. In December 2019, CAP issued a report denying Arrayit’s request after determining that because the tests Arrayit performed were “complex,” Defendant was required to have a license under CLIA to load the assays as the lab manager (which he did not), and Arrayit needed to have a lab manager that was on-site more frequently. Arrayit disagreed and provided a detailed response. CAP rejected the application for reconsideration. Defendant was advised that CAP’s determination to deny accreditation would lead to a revocation of its CLIA certification. Defendant was also advised that any person who intentionally violates CLIA requirements was subject to sanctions, including imprisonment. Defendant did not disclose the revocation to investors, despite having issued earlier public statements touting Arrayit’s purported successes in obtaining licensure and accreditation by CDPH, CLIA, and CAP.
Thereafter, Defendant submitted a new application for a CLIA COC. The Government maintains that this application contained similar false statements regarding the roles and qualifications of laboratory personnel, and failed to address the deficiencies identified by CAP. The application was granted in April 2020. CDPH subsequently requested proof that Arrayit had cured the deficiencies identified by CAP, but Arrayit failed to provide such documentation.
